Podcasts about quality systems

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements.00:00 Introduction and Guest Introduction00:37 The Importance of Documentation in Quality Systems01:30 Hierarchy and Structure of Documentation02:44 Standard Operating Procedures (SOPs) vs. Work Instructions11:22 Document Control and Change Management15:52 Roles and Responsibilities in Quality Systems18:20 RACI Matrix and Its Importance20:47 Common Issues in Documentation and Training25:25 Conclusion and Where to Find More InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Guests: Roger Gerard: Owner of Sloan & Gerard Consulting and Author Dr. Roger A. Gerard is the owner of Sloan & Gerard Consulting, a private consulting practice serving executives and boards in strategic planning, operational planning, executive coaching, and management development. He also specializes in process improvement, and the use of lean methodologies in bringing about significant and measurable organizational improvement. He is the former Chief Learning Officer for ThedaCare, an integrated healthcare delivery system, retiring from that position in 2014 after 23 years in that role. Dr. Gerard has a 52-year career history leading executive and management development initiatives, in both large and small organizational environments. His work has been primarily within the healthcare industry, but he has also spent a quarter of his career consulting in manufacturing and service industries nationwide. In addition, he is a creative photographer, and provides help to his wife Debra in her fine art business. Previously, Dr. Gerard served as Vice President of Northern Michigan Hospitals and as theDirector of Organizational Development. Before joining NMH, he was Creative Manager for Quality Systems for Sandy Corporation where he consulted with major clients (Burroughs, IBM, General Motors, Hyatt, etc.) on systemic leadership development and quality improvement projects. Dr. Gerard is the author of Owning the Room: Leading with Mind, Heart and Spirit to Make Extraordinary Choices in a Demanding World and the forthcoming title, Lead With Purpose: Reignite Passion and Engagement For Professionals in Crisis. He also co-authored On the Mend: Revolutionizing Healthcare to Save Lives and Transform the Industry. Dr. Gerard has presented at numerous national conferences and locally throughout Wisconsin and Michigan on leadership and lean in the healthcare industry. He earned his Ph.D. in Management and Applied Decision Sciences from Walden University in 2001. Join us as we discuss how leaders can cull the cynics, apathetics and naysayers Host: Andy Goram

Send us a textTradespeople bring expertise, innovation, high quality, and leadership to product development. If we're lucky enough to be able to work with them, they're an invaluable part of the engineering team. What about when we're working without them? How can we create a culture of craftsmanship in a company that uses a quality system? In this episode, we talk about the crafts' and trades' relationship with quality systems, and steps toward creating a culture of craftsmanship.Visit the podcast blog for this episode.**BI-WEEKLY EPISODES**Subscribe to this show on your favorite provider and Give us a Rating & Review to help others find us!**ONLINE COURSE**FMEA in Practice: from Plan to Risk-Based Decision Making is enrolling students now. Join over 200 students in taking your FMEA to the next level. Click Here**MONTHLY DIGEST**Subscribe to the free monthly e-newsletter at www.qualityduringdesign.com.About meDianna Deeney is a quality advocate for product development with over 25 years of experience in manufacturing. She is president of Deeney Enterprises, LLC, which helps organizations optimize their engineering processes and team performance by promoting the use of reliability and quality methods during design. She offers consulting services for managers and directors, training for engineers through the Quality During Design program, and other practical resources.

In this episode, Jill Hoffman, Senior Director of Food Safety and Quality at B&G Foods, and Jacqueline Southee, North American representative for the FSSC 22000 Foundation, discuss their respective career journeys, challenges women face in the food safety industry, and the critical importance of networking and mentorship. Jill and Jacqueline emphasize the need for proper education in food safety, the development of cultural impact at all organizational levels, and the advocacy for a better understanding of ISO management systems in the U.S. This episode delves into the empowering community of Women in Food Safety, exploring opportunities for future initiatives and the importance of engaging young professionals in the field. Episode Highlights: 02:49 Jill Hoffman's Career Journey in Food Safety 05:10 Jacqueline Southee's Diverse Background and Career Shift 08:31 The Importance of Networking and Mentorship 20:53 Challenges and Opportunities for Women in Food Safety 28:01 Expanding the Women in Food Safety Community Jill is currently the Senior Director of Food Safety and Quality at B&G Foods. Before moving over to B&G, Jill was previously the Director of Global Food Safety and Quality Systems at McCormick & Co., Inc. Over her career she has worked across numerous product categories in various functions to include Food Safety and Quality, Operations, and Continuous Improvement. Jill has had the opportunity to engage and speak in various forums across the globe on topics such as supply chain integrity and food fraud and has contributed to various publications on these topics. Jill has a passion for transforming the quality and food safety functions through continuous improvement, digital enablement, and data analytics. She sees an abundance of opportunities to create efficiency and insights by greater adoption within food companies. Jill holds a B.S. in Food Science from Virginia Tech and a Masters in Food Safety from Michigan State. Connect with Jill:LinkedIn: https://www.linkedin.com/in/jill-hoffman-853a9a12/ Jacqueline Southee is the North American Representative for Foundation FSSC 22000, the owner of the globally recognized GFSI benchmarked food safety certification system, FSSC 22000, and the new FSSC 24000 certification for Social Management Systems. Based in Washington DC, Jacqueline works with the public and private sector to build a broader understanding of how accredited FSSC 22000 certification and the ISO management system approach can contribute to global harmonization, forge international compliance and help industry achieve the UN sustainability goals. A native of the UK Jacqueline is a “seasoned” player with a PhD in Animal Science from he University of Nottingham and a background in international business development. Jsouthee@fssc.com Connect with Jacqueline: Company Website: www.fssc.com LinkedIn: https://www.linkedin.com/in/jacquelinesoutheebruner/ For more insights: Book a call: https://bit.ly/4cToGDs Follow me on my YouTube Channel: https://bit.ly/47GgMdn Sign up for my Weekly Newsletter: https://bit.ly/3T09kVc See omnystudio.com/listener for privacy information.

Welcome back to the podcast, Episode 252, as we kick off 2025 with fresh insights and learnings. This episode is a deep dive into the heart of quality assurance, exploring why achieving excellence in the manufacturing industry goes beyond simple end-line inspections. Join your hosts, Adrian and Renaud, as they break down the crucial concept that 'quality is made, not found.' We explore W. Edward Deming's significant influence on manufacturing philosophies, particularly in Japan, and how his insights led to a quality revolution. This episode examines real-world scenarios in automotive and electronics giants like Toyota and Apple, offering invaluable lessons on how a meticulously structured approach to product design and development can lead to superior product quality and reliability. The podcast also navigates through the essentials of implementing a robust quality system - from initial product design phases, and supplier qualification, to the final stages of manufacturing. Discover why companies like Toyota shine as examples of building quality from the ground up and how other industries can emulate such successful strategies. This is a timely reminder for manufacturers and business leaders to reassess their quality systems and ensure that proactive approaches are in place to maintain excellence in their products and processes.    Show Sections 00:00: Introduction: A Fresh Start to 2025 and CES Las Vegas 02:56: Why Quality Starts at the Source 07:38: Deming's Legacy: Japan and a Philosophy of Quality Control 12:35: The need for a Systematic Quality Management System 18:34: Common Pitfalls: When Inspections Aren't Enough 21:32: The Proactive Approach: Embedding Quality in Processes 35:10: Industry Examples where Quality Systems were Implemented Successfully 41:24: Wrapping Up   Related content... What Is Quality Assurance? Sofeast QA Program: Reduce Your Risks When Launching New Products How To Choose Which Product Quality Inspection You Need? The Sad State of Quality Systems in Most Chinese Factories What Is The Minimum Viable Quality Management System For A New Manufacturer? [8 Steps]   Get in touch with us Connect with us on LinkedIn Contact us via Sofeast's contact page Subscribe to our YouTube channel Contact us on X @sofeast Prefer Facebook? Check us out on FB

Send us a textWhat does the FDA jurisdiction for LDTs mean for the labs? Do they need to worry? How do they need to change the way they operate?In this episode, I talk with Dr. Thomas Nifong, a clinical pathologist and VP of CDX operations at Acrovan Therapeutics, about the recent FDA ruling on laboratory-developed tests (LDTs) issued on May 6th, 2024. We discuss the implications of considering LDTs as medical devices, requiring regulation, and explore the authority of FDA versus CLIA. The conversation also covers historical contexts, practical implications of regulatory changes, and the roles of organizations like CAP, ACLA, and AMP in legal challenges against the FDA. We dive into the differences in requirements between CLIA and FDA, New York's alternative approval route, and potential impacts on lab operations and compliance. Join us for an insightful conversation filled with essential information for those in the field of molecular pathology.00:00 Introduction and Special Guest Announcement00:24 FDA's New Rule on Laboratory Developed Tests (LDTs)01:58 Recording the Podcast: A Casual Lunch Conversation03:47 Understanding FDA's Authority Over Medical Devices08:07 Disputes and Legal Challenges12:03 Practical Implications and Industry Reactions12:47 Understanding FDA's Focus: Safety and Efficacy14:11 The Role of CMS and Medical Necessity14:48 Congressional Involvement and Legal Authority16:06 Impact on Labs and Future LDTs18:33 Quality Systems and Compliance20:16 Modifications and Software Updates21:16 Conclusion and Next StepsSupport the showBecome a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation. Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony.Key Timestamps:[00:01] – Introduction: Vincent Cafiso's background as an FDA investigator and transition into industry.[04:15] – Crayo Consulting's Scope: How Creo Consulting supports MedTech companies from launch strategy to compliance.[12:40] – Bridging R&D and Production: Overcoming challenges when R&D environments don't align with production standards.[19:50] – Top Trends in Quality Systems: Addressing documentation gaps and missing standards in design history files.[27:10] – Management's Role in Supporting Quality: The importance of management's involvement in enforcing quality controls and processes.[38:30] – From FDA to Industry: How Vincent's FDA background influences his approach to quality and compliance.[54:25] – Skip-Level Meetings and Breaking Silos: Enhancing collaboration and communication within large organizations.[1:06:00] – Final Takeaways and Advice: Building a culture of quality and fostering innovation while staying compliant.Key Quotes:“The regulations are written for tongue depressors and pacemakers—two very different devices. It's up to the companies to interpret how to apply those rules to their specific products.” – Vincent Cafiso“Documentation shouldn't just be a checkbox for submission. There's a lot more innovation happening that doesn't make it onto paper because companies don't realize its value.” – Vincent CafisoKey Takeaways:1. MedTech Trends:Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework.Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance.Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality.2. Practical Tips for MedTech Professionals:Integrate Quality Early: Implement quality controls and validation processes at the R&D stage to avoid repeating tests or redesigns during production.Leverage Skip-Level Meetings: Encourage direct communication between upper management and employees for better understanding and faster issue resolution.Document Everything: Don't treat documentation as a formality. Capture all the engineering studies and real data to support design decisions and regulatory submissions.3. Questions for Future...

Joining me for episode #106 was Mr. Naveen Agarwal, the Founder at Creative Analytics Solutions. If you're in Med-Tech, & you browse LinkedIn, chances are you've seen some of Naveen's content, especially centered around Risk.Naveen comes to the show with over 25 years industry experience. He's worked for well known organizations like Kimberly-Clark as a Research Scientist and for J&J in Business Analytics & Quality Management. Over the last 7 years or so he has led Creative Analytics which is a consulting firm providing Quality Systems expertise to Medical Device organizations through it's trademarked platform called Exceed Innovative Quality Solutions Platform across 4 broad areas (Customer Experience, Regulatory compliance, Risk Management & Quality Culture) Some of the highlights we discussed:-Biggest pitfalls when it comes to device manufacturers risk management programs -What are some low hanging fruit teams can go after when it comes to improving risk management safeguards? -Regarding the new QMSR , from a risk perspective, what will be the biggest challenges for companies when it comes to implementation ?...and so much more!Naveen Agarwal on LinkedIn:https://www.linkedin.com/in/naveenagarwal/Creative Analytics Solutions:https://www.linkedin.com/company/exeedqm/

About the Guest(s): Christina Kasprzak and Dr. Megan Vinh are the Co-Directors of the Early Childhood Technical Assistance Center (ECTA). Christina brings her expertise in leading initiatives to develop equitable and sustainable state systems for children with disabilities and their families. Her personal connection to the cause comes from a family that valued community and respect for all, emphasizing the importance of education in life. Dr. Megan Vinh's drive is equally personal, vaulting from family experiences into a professional passion for inclusion as a human right. She co-directs not just ECTA, but also the STEM Innovation for Inclusion in Early Education (STEMIE) center, championing proactive and inclusive STEM learning for young children.Episode Summary: In a candid conversation with Tim Villegas, Christina Kasprzak and Megan Vinh discuss their role in shaping inclusive educational systems for early childhood. The episode begins with an exploration into the work ECTA does in supporting state administrators and educators. With a heartwarming emphasis on equitable access, these leaders exemplify the importance of building an all-embracing infrastructure from policy to practice.Christina and Megan delve into the tools and resources provided by ECTA that supports practitioners and families directly, such as the DEC recommended practices guides and family-friendly video materials. As they reveal challenges in creating inclusive systems, including the need for de-siloing state departments, they reaffirm the proven benefits of inclusion for children both with and without disabilities.Transcript: https://otter.ai/u/Vz2ZPx3GpJO_iB8HGeqX51SI9e4Key Takeaways:ECTA predominantly supports state administrators in improving early intervention and preschool special education programs, advocating for all-encompassing and effective practices.Both guests emphasize the profound personal and professional belief in the power and necessity of inclusive education for every child.Christina and Megan discuss the practical tools ECTA offers, which are popular with professionals and families.Inclusion benefits all children, and dismantling myths around it is essential to its advocacy and implementation.The guests point out that everyone has a role to play in advocating for inclusion, and change is possible when people at every level of the system lead from their positions.Resources:ECTA Center: https://ectacenter.org/Practice Improvement Tools: https://ectacenter.org/decrp/Indicators of High-Quality Inclusion: https://ectacenter.org/topics/inclusion/indicators.aspState Examples for Inclusion: https://ectacenter.org/topics/inclusion/stateexamples.aspMCIE: https://www.mcie.org/ Hosted on Acast. See acast.com/privacy for more information.

The FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing. With over two decades of dedicated service in the biopharmaceutical industry, most recently serving as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos provided profound insights into the pivotal role of phase-appropriate quality systems in managing drug development from research to commercialization. Our discussion focused on how these systems facilitate the rapid delivery of treatments to patients in urgent need. Discussion points include: Defining Phase-Appropriate Quality Systems: Carlos detailed these systems as strategic frameworks designed to adapt to the requirements of different stages of drug development, emphasizing their critical role in accelerating the development process. Regulatory Framework and Impact: Insights into how FDA guidelines are tailored to expedite the transition from laboratory research to market, highlighting the regulatory nuances that allow for such flexibility. Handling Variability in Drug Development: Strategies for managing the inherent variability in early development phases were discussed. Carlos emphasized the necessity of flexible, responsive quality systems that facilitate quick adaptations. Analytical Testing and Development Oversight: Carlos explored the significant role of analytical testing in early phases, focusing on controlling and understanding variability to improve assay development continuously. Challenges in Preclinical to Clinical Transition: He underscored the importance of maintaining consistency in the quality of preclinical materials to ensure seamless progression into clinical trials. Importance of Effective Change Control Systems: The conversation covered how early-stage quality systems should anticipate and manage frequent changes to support rapid learning and adaptation. Strategic Approach to Quality System Design: Carlos discussed designing quality systems that reflect the company's risk tolerance and the urgency of patient needs, effectively balancing speed, cost, and compliance. Future Trends in the Life Sciences Sector: Carlos provided predictions on the evolution of quality systems to meet the dynamic needs of ongoing and future drug development projects. Carlos Yuraszeck is a distinguished leader in biopharmaceutical compliance, operations, and quality assurance, specializing in cell therapy manufacturing. Over his extensive career spanning more than two decades, Carlos has significantly impacted the biopharmaceutical industry through his leadership in various pivotal roles. As the Executive Director of GMP Operations at Astellas Pharma US, he led the transformation of research groups into fully operational GMP manufacturing facilities. Earlier, as Senior Vice President of Technical Operations at Talaris Therapeutics, he managed operations focused on groundbreaking organ transplantation therapies. At Celgene, Carlos directed clinical production and supply, where he scaled up manufacturing operations to support the delivery of life-saving CAR T-cell therapies. His tenure in the industry is marked by a commitment to excellence, deep regulatory knowledge, and strategic oversight, which have driven the successful development and commercialization of novel therapies. Carlos's leadership style emphasizes collaboration, transparency, and continuous learning, aiming always to enhance patient outcomes and advance the field of biopharmaceuticals through innovative and efficient manufacturing practices.

On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the second half of the episode talk about risk acceptability charts, risk & quality policy, explaining vs. justifying risk based decision making with regards to the traffic light charts that most companies use for risk acceptance. Episode Chapters: 02:00 Interpreting the QMSR and Its Implications 05:56 Impact of QMSR on Risk Management 08:34 Risk Management in Practice 12:09 Insights from FDA Inspections and Warning Letters 23:30 The Importance of Process-Based Approach 24:57 Deep Dive into Risk Policy and Risk Acceptability 26:05 Understanding the Framework of 14971 26:42 The Role of Quality Policy in Risk Management 27:32 Risk Control 29:47 Risk Acceptability in Risk Policy 30:59 Understanding Risk Matrix 32:16 Risk Control and Quality Policy 41:00 Understanding Risk Acceptability Charts Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal. In this episode, Naveen discussses: - How FMEA's fit into ISO14971 - pFMEA's from External Partners and linking to risk files - Simplifying Risk Management outputs for Audit Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert. Show Notes and Links: Let's Talk Risk Newsletter: https://naveenagarwalphd.substack.com Naveen's Video on “When FDA Disagrees with your risk calculation method”: https://youtu.be/Y14_RTHMGqw Warning Letter 1: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medtronic-inc-617539-12092021 Warning Letter 2: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irhythm-technologies-inc-643474-05252023 M

On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO) Clifton Ericcson How concepts/tools like these fit into the ISO14971 and ISO TR 24971 framworks Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

Silvia Liñán TreviñoConexión | Afinidad | Disciplina| Aprendedor | LogradorSocia fundadora de Concordia Bienestar y Productividad, Consultora experta en PYMES, Coach ejecutiva certificada por la Universidad Iberoamericana, Coach de fortalezas certificada por Gallup. Obtuvo el Certificado de Competencia Laboral en Consultoría por la International Certification of Quality Systems y el registro como Consultor Pyme-JICA por la Agencia de Cooperación Internacional del Japón. Actualmente estudia la Maestría en Desarrollo Humano en el ITESO de Guadalajara.Cuenta con más de 20 años de experiencia en el ámbito organizacional. Ha realizado proyectos en diferentes áreas de negocios para cerca de 300 empresas de muy diversos sectores y giros. Ha colaborado con el International Center for Work and Family del IESE Business School en los estudios: “Responsabilidad Familiar Corporativa en Cd. Juárez”, “Mujeres y hombres en trabajo en remoto: cómo, cuándo y quién” y “El futuro del trabajo”. Actualmente realiza su trabajo de grado enfocado en mujeres empresarias de pequeñas y medianas empresas.El Llamado del Coach (vía You Tube) es un programa que permite, a los coaches actuales y a quienes quieren convertirse en coaches, interactuar con coaches en fortalezas que han encontrado el éxito en el desarrollo basado en fortalezas.Durante cada sesión, profundizaremos en estrategias y tácticas que puedes llevar a tu organización y ayudarán a ti y a tu equipo a lograr un mejor desempeño.Aprende más sobre otros recursos de coaching basado en fortalezas de Gallup:• Artículos & Videos• Programas en línea• Guías & Reportes• Inscríbete a nuestro boletín informativo en inglés (Newsletter)También visita Gallup Access.

Silvia Liñán TreviñoConexión | Afinidad | Disciplina| Aprendedor | LogradorSocia fundadora de Concordia Bienestar y Productividad, Consultora experta en PYMES, Coach ejecutiva certificada por la Universidad Iberoamericana, Coach de fortalezas certificada por Gallup. Obtuvo el Certificado de Competencia Laboral en Consultoría por la International Certification of Quality Systems y el registro como Consultor Pyme-JICA por la Agencia de Cooperación Internacional del Japón. Actualmente estudia la Maestría en Desarrollo Humano en el ITESO de Guadalajara.Cuenta con más de 20 años de experiencia en el ámbito organizacional. Ha realizado proyectos en diferentes áreas de negocios para cerca de 300 empresas de muy diversos sectores y giros. Ha colaborado con el International Center for Work and Family del IESE Business School en los estudios: “Responsabilidad Familiar Corporativa en Cd. Juárez”, “Mujeres y hombres en trabajo en remoto: cómo, cuándo y quién” y “El futuro del trabajo”. Actualmente realiza su trabajo de grado enfocado en mujeres empresarias de pequeñas y medianas empresas.El Llamado del Coach (vía You Tube) es un programa que permite, a los coaches actuales y a quienes quieren convertirse en coaches, interactuar con coaches en fortalezas que han encontrado el éxito en el desarrollo basado en fortalezas.Durante cada sesión, profundizaremos en estrategias y tácticas que puedes llevar a tu organización y ayudarán a ti y a tu equipo a lograr un mejor desempeño.Aprende más sobre otros recursos de coaching basado en fortalezas de Gallup:• Artículos & Videos• Programas en línea• Guías & Reportes• Inscríbete a nuestro boletín informativo en inglés (Newsletter)También visita Gallup Access.

On this episode, we were joined again by Susan Neadle! This episode was focused on the current state of Combination Products globally. Susan and I discuss: - CPC Summit and Updates from FDA - Essential Performance Requirements(EPR's) - ASTM Harmonization for an International  Combination Products Terminology Standard -Different Approaches to Combination Products Globally : US, EU, UK, Canada, Japan, China, Australia, and Saudi Arabia -Upcoming Combination Products Conferences in Q4 Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience.  She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee. Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development. Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.

Stuart Smith Stuart Smith is the IT Director at Medtronic. Stuart has been working at Medtronic for 22 years, climbing the IT ladder from Principal IT Project Leader to IT Director of R&D and Quality Systems. Starting out in economics and languages, Stuart came to IT in an indirect way, but has been with the...

Way of the Quality Warrirorwayofthequalitywarrior.comThe tools and concepts of Quality are powerful instruments to make things better--products, processes, and services. This podcast explores those ideas plus concepts of psychology, social and cultural norms, strategy, and business to strengthen the capability of professionals motivated to make things better--the Quality Warriors. The host is Keith Fong who is a Six Sigma Master Black Belt, Shainin Red X Master, and Robust Engineering Coach. He has over 20 years as a quality and continuous improvement practitioner, teacher, and coach. He has supported functions ranging from Engineering and Manufacturing to Finance and Human Resources internal to his employer and at suppliers and customers.In Systems We TrustThe "In Systems We Trust" podcast is where owners and leaders of businesses talk about the systems, processes, and operational efficiency practices they use every day to make their organizations successful. If you love order, structural organization, and productivity, then this is for you!http://insystemswetrust.libsyn.com/Need a domain for your show? See Name Cheap.Systems Made Simple systemsmadesimple.co When you depend solely on your own effort to scale your business, you're capping your influence, income, and impact. But we'll let you in on a secret: there's NO limit to systems and support you build into the back-end of your business so you can step forth as the Visionary Leader you were born to be. Listen in as Courtney Elmer, business systems expert and Founder of The EffortLESS Life®, shows you how to simplify your workflows and get the right systems, structure, and support in place so you can spend more time in your zone of genius. Ranked globally among the top shows in Business and Marketing, the SYSTEMS MADE SIMPLE™ podcast is the best business podcast for everything you need to know about streamlining your business systems, hiring and growing your team, scaling beyond six figures, and stepping fully into your role as the Visionary Leader of your company. It's time for a new way to live + work: welcome to SYSTEMS MADE SIMPLE™ResourcesThe School of Podcasting - use the coupon code trailerAudry.io - Podcasting is hard - our community makes it easierPodpage . A great looking website for your show with zero codingMore resources

In this episode, Kyle Rose from Rook Quality Systems and Duane Mancini discussthe FDA's ISO-13485 transition plan, when it was announced, what it looks like, the differences 21 CFR Part 820 vs. ISO 13485, the importance of a risk based approach in quality, updates on the MDR and current trends, could the FDA move towards requiring more clinical data from medical device manufacturers, if regulatory and quality were the only factors in determining your global get-to-market strategy…where would you go, and so much more. Kyle Rose LinkedIn Rook Quality System Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn

The audit procedures require end-to-end traceability and visibility into your processes. While they might vary a bit across industries such as medical or aerospace, the fundamentals are still the same. They are the same in how you vet your suppliers, how you ensure that the due dates are accurate on your POs, and finally, how you deliver to your customers with consistency. So how do you ensure that you are not going to get any red flags during the audit process?In today's episode, our guest, Anna Reyes-Potts, shares her insights into the audit and quality processes for machine shops. She also discusses the differences in the quality and audit process for various industries. Finally, she discusses how the processes of a machine shop differ from generalized manufacturing, including inventory, inspection, procurement, and supplier quality control.For more information on growth strategies for SMBs using ERP and digital transformation, visit our community at wbs.rocks or elevatiq.com. To ensure that you never miss an episode of the WBS podcast, subscribe on your favorite podcasting platform.

On this episode of the podcast, Naveen Agarwal PhD from Creative Analytics Solutions. Naveen and I discuss: Running almost 1500 miles and the importance of constraints Risk Management Vigilance vs. Surveillance Customer Experience focused Quality Improvement and Post-Market Surveillance Common Issues with P1/P2 Implementation Data Based Decision Making Frameworks Methods NIST Malcolm Baldridge Award Appraisal Toastmasters Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

Joining me on this episode was the VP of Quality Systems & Compliance at Roche Molecular Solutions, Ms. Michaela Hart. Michaela is a leader I personally have a lot of respect for. With her no BS style, she's led teams for the better part of 30 years for a variety of organizations, but primarily at Roche. She likes to go fast in business and in life being an avid race car driver!She really works her butt off to empower teams while holding them accountable.To help inspire other leaders, she wrote a book in 2015, "Let them Lead"..How to Command Less & Accomplish More (available on Amazon).She's also in the process of writing a brand new book which we discuss during the episode as well.-Hiring givers & firing takers-Performance management, what exactly does this truly mean?-Managing across multi-generational workforces and the key differences-The importance of having a personal 'board of advisors'-Michaela's upcoming book, "Let them leave"...and much more!

On this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss: Her career starting in consumer health and pivoting into Medical Devices then Pharmaceuticals Design to Value, Design Excellence and Process Excellence The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was revealed. Creating future plans using tools like the Merlin Exercise, and Future/Back Vocabulary in Combination Products AAMI TIR 48 and TIR 105 Her involvement in ASTM, AAMI, ISPE, FPIA, DIA, AFDA, TOPRA and RAPS Prioritization, Passion and her upcoming book ------------------------------------- Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge, and genuine passion for sharing that knowledge, with others. Susan's leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA's 2021 Awards for Regulatory Affairs Excellence. She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, and teaches a Master's Curriculum on Combination Products at University of Maryland Baltimore Campus. Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She served as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction. Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health sectors, including strategic Enterprise leadership as Chair of J&J's Design Council, advancing world-class practices in customer-centric product/process design and development. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.

On this episode we had Kathy Walsh, Director and Principal at Quality Systems. Kathy and I discuss: Her Book: "Eliminating the Gobbledygook: secrets to writing plain language procedures" Her background starting as a PhD Microbiologist and moving into Quality Systems/Technical Writing Where most companies have issues with their procedures Plain Language Skills: Active voice vs. passive voice, Process Mapping, Inference Building, Sentence Parsing, document structure and more The origins and history of "plain language" The history of Fonts How to make for more efficient document reviews and advice she has for writing technical documents and procedures Dr. Kathy Walsh is a scientist, a PhD biochemist with post-doctoral work turned QS expert. She helps companies in regulated industries design & implement quality compliance solutions that increase productivity and master the quality challenges in their marketplace. She most recently wrote her book "Eliminating the Gobbledygook: secrets to writing plain language procedures" and is joined us from Melbourne, Australia. ------------------------------------------------------ Links: Kathy can be reached on LinkedIn HERE QSN: https://www.qualitysystemsnow.com.au/ Eliminating the Gobbledygook: secrets to writing plain language procedures: Book Link

Welcome to Breaking The Chain – The Leadership Series, hosted by Director of Career Coaching and Leadership Development at Impel Talent, Terentia Browne.In this episode Terentia sits down with Michelle Williams-Swartz,  Global Head of Quality Systems and Performance at Johnson and Johnson. Together they talk about Michelle's journey throughout the COVID-19 pandemic and her experience in growing her global team virtually. Follow Impel TalentLinkedIn: Impel TalentTwitter: @ImpelTalentFacebook: @Impel TalentInstagram: @ImpelTalentJoin us for illuminating discussions, practical insights, and a roadmap for thriving in an ever-shifting world. Subscribe now and join the conversation as we break new ground in leadership excellence!

Description: With increasing compliance requirements and resource challenges around the world, there is a growing need for the integration of digital platforms to reduce errors, reduce the need for double checks/signoffs, and provide greater process efficiency. There is a need for laboratories to implement workflow tools that automate processes and test rules to improve efficiency. Join our speaker in learning how in an evolving health care industry automation is possible for the laboratory's goals.   About our Speaker: Aaron W. Hurst MLT(ASCP) is the Laboratory Supervisor of Quality Systems of the Newton Medical Center in Kansas. His responsibilities include supervisory roles as the second shift supervisor, blood bank supervisor, and chemistry laboratory supervisor. He still retains these last 2 responsibilities along with the quality systems management role. Aaron has devoted his medical technologist career to help evolve the Newton Hospital laboratory with activities focused on improved efficiency, applied lean management, and enhanced patient safety. Aaron has been a contributor speaker in National and International forums. He has been recognized by the American Red Cross, Wichita, for “maximizing efficiencies.” and recently by the Medical Laboratory Observer for Automation in Action in the blood bank.

Scalewerks Mark Jacobs, Scalewerks.co   – The Sharkpreneur podcast with Seth Greene Episode 674 Mark Jacobs Mark B. Jacobs has spent 30 years in executive leadership successfully guiding major growth initiatives – many starting as turnaround efforts. He has led re-capitalizations, start-ups, and key organizational change agendas that have scaled company growth and performance. He co-authored the SmartScale process which is built on his years of hands-on experience and expertise in Lean Manufacturing, Quality Systems, Sales & Operations Planning, Category Design & Development, Leadership Development, and Technology-Driven transformations.   Listen to this illuminating Sharkpreneur episode with Mark Jacobs about growing and scaling businesses. Here are some of the beneficial topics covered on this week's show: ●    Why entrepreneurs need to know their audience to provide the right product. ●    How entrepreneurs need the right business model to grow their businesses. ●    Why leadership is everything when it comes to a company's culture. ●    How people grow is an indicator of how their business can grow. ●    Why entrepreneurs should stop pitching and just be themselves.   Connect with Mark: Guest Contact Info LinkedIn linkedin.com/in/mbjacobs Links Mentioned: scalewerks.co   Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Digital Transformation Initiative" This discussion was moderated by Daniel Matlis and features Sam Cheemokati, Paul Hurlocker, and Ron Schardong.  The discussion will be focused on exploring organization-wide digital transformation initiatives. The panel will share their firsthand experiences of point solutions to platforms transitions. And, the best practices when shifting to cloud computing and the cloud-first approach. About the panel: Daniel Matlis Daniel R. Matlis is the Founder and President of Axendia – a trusted advisor to Life-Science and Healthcare executives on business, technology, and regulatory issues. Dan's career in the industry spans over 20-years and has included projects in research & development, manufacturing, regulatory compliance, business development and information technology. Prior to founding Axendia, Dan was General Manager & VP at Stelex (now a GE company) – a leading consultancy to life-science companies. He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.   Sam Cheemakoti Sam is the GMP Head at Beiersdorf for the Coppertone Division overseeing GMP compliance of its computer and automated systems. Sam has held positions of increasing responsibility at various Pharmaceutical companies such as Bayer, Merck, and Schering Plough in the areas of Computer Systems Validation, IT Compliance, and Quality Assurance. As a Quality leader with 20+ years in the industry with a demonstrated ability to produce and deploy Part 11 and Data Integrity remediation programs, validation programs, quality systems, strategic initiatives for Quality and Compliance especially under conditions of the consent decree, acquisitions, and divestitures has lent him unique perspectives as a change ambassador and thought leader. Sam earned his MS in Industrial Engineering from Louisiana Tech University and his Project Management credentials from Villanova University. He more recently completed a course on Digital Transformation: Leading People, Data and Technology from the University of Berkeley under their Executive Education Program in order to gain synergies between the two journeys of Digital Transformation and Computer Software Assurance for Quality.    Paul Hurlocker Paul is the CTO at Spring Oaks Capital, a technology-driven financial services company whose mission is to reinvent the debt recovery industry by providing a customer-centered user experience and streamlined operations powered by data and machine learning. Paul previously served as the Senior Director and Vice President of the Center for Machine Learning for Capital One. Paul founded Notch, Co and served as the CEO before selling the company to Capital One. Ron Schardong Ron is privileged to lead Johnson & Johnson's Technology Quality group responsible for computerized systems validation of business applications in the Medical Devices, Consumer, and Pharmaceutical segments worldwide. The applications include ERP, Warehouse Management, Manufacturing, Laboratory, Quality Systems, Clinical, R&D, Enterprise Tools, Services, and Infrastructure. He has over 25 years of experience in quality engineering, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of FICSA Group (FDA + Industry Computer Assurance Group).   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

In this episode, Stacey is joined by Valarie King-Bailey to discuss some of the key topics from the recent CSV panel on "Excellence and Next-Generation Approaches to Quality System Monitoring." The panel provided reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enabled facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control. Valarie will share his perspective on these topics as an industry expert.  About our Guest Valarie King-Bailey is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products, and solutions.  OnShore's product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market.  ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works.  At QUMAS, an Irish-based software company, she served as Chief Marketing Officer. She was responsible for all global tactical and strategic marketing initiatives and the development of their validation toolkit.  Valarie founded OnShore Technology Group in 2004.  OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008).   She also received a nomination for the Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from Wisconsin–M Madison (1982).   She is a member of the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society (RAPS), and a U.W. College of Civil Engineering Advisory Board Member. She can be reached at vkbailey@onshoretech.com  Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.     

This week, Stacey welcomes back Nuala Calnan and Lori Richter for another episode in the Risk Revolution series. In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource.   Resources in this episode: Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein The Surprising Power of Questions HBR Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT Bias, Heuristics & Risk (Pt. 2) on Risk Revolution | IVT   About Our Speakers Lori Richter Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx, she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada, and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a Ph.D. at Technological University Dublin. Nuala Calnan –  Nuala is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the  Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient-focused regulatory science research projects at the Masters and Ph.D. levels.   Tiff Baker –  Tiff Baker, is a Senior Consultant at Valsource.  Tiff has been working full time in the QRM space for over ten years, and in micro roles within the industry prior to that.  She has implemented QRM programs for companies internationally, delivered risk training to industry and regulators alike, developed custom risk tools to meet client needs, and facilitated many risk assessments over the years.  She is a co-lead for the Parenteral Drug Association's Remote Audits and Inspections Task Force as well as an instructor for the PDA Training and Research Institute.  In addition, Tiff contributed as an author to ISPE's Baseline Guide 5 for Commissioning and Qualification to incorporate risk as well as several Points to Consider documents for the PDA.   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

Today, joining the SCC for a great conversation is one of its founding members David Vaillencourt, Founder & CEO of the GMP Collective. David brings a wealth of experience in GMP (Good Manufacturing Practices) and Quality Systems. Together, we will dive into what GMP and Quality Systems mean for Cannabis Operators and the industry at-large, what are some of the best practices around quality control and Cannabis, as well as how GMP and Quality Systems help not only with driving sustainability, but also risk mitigation. It's a quality episode, pun definitely intended so you don't want to miss out! --- Send in a voice message: https://anchor.fm/sustainable-cannabis/message

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.Some highlights of this episode include:Why are some notified bodies not interested? There's a ton of work, audits, and corrective actions. They don't view it as necessary to move forward and pursue.First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.Even if you don't have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance. Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.Memorable quotes from Joanne LeBrun:“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we're supposed to go live. They have a year to get more notified bodies.”“I think that notified bodies are very overwhelmed.”“While the MDR has more constituents involved, I think that it's going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.” “That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEU IVDREU MDRNotified BodiesNew Approach Notified and Designated Organizations (NANDO)ISO 13485:2016ISO 14971:2019 ISO/TR 24971:2020Medical Device Single Audit Program (MDSAP)Overview of the 510(k) ProcessAllison Komiyama from AcKnowledge Regulatory StrategiesGlobal Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun Greenlight Guru AcademyGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Host Tom Bronson chats with guest Rick Robinson, Managing Director of Ramsee Consulting Group, on this week’s episode of the Maximize Business Value Podcast. The two discuss leadership development that leads to success including the three main goals of leaders and Rick’s four C’s: commitment, content, coaching and community. Tom regards company CEOs as the keeper of the company culture which is imperative because culture is the only sustainable competitive advantage businesses have in the marketplace. Interested in building a strong leadership team to maximize your business value? Listen now!As Managing Director of Ramsee Consulting Group, Rick Robinson has focused developing and delivering a variety of programs in the areas of Leadership Development, Project Management, ERP systems, Lean Manufacturing, Teambuilding, Quality Systems, Strategic Planning, Motivation, Measurement Systems and Change Management. In the last ten years Rick has facilitated a number of strategic and project planning sessions for a variety of clients, including Wingstop Restaurants, the Town of Addison, DeKalb Office, Malphurs Interactive, the City of Richardson, the City of Georgetown, the North Dallas Chamber of Commerce, and Greenberg Farrow Architecture.  His inclusive and highly interactive style has earned him high praise from his clients and conference attendees. Rick earned degrees in Accounting and Finance from Texas A&M University in 1985 and taught Economics and Accounting in the Fiji Islands as a Peace Corps volunteer after college. His client list also includes GM, Chrysler, Nortel, Picker, Del Monte Foods, Steelcase, Texas Health Systems, Dallas HR, and Lloyds of London.Tom Bronson is the founder and President of Mastery Partners, a company that helps business owners maximize business value, design exit strategy, and transition their business on their terms. Mastery utilizes proven techniques and strategies that dramatically improve business value that was developed during Tom’s career 100 business transactions as either a business buyer or seller. As a business owner himself, he has been in your situation a hundred times, and he knows what it takes to craft the right strategy. Bronson is passionate about helping business owners and has the experience to do it. Want to chat more or think Tom can help you?  Reach out at tom@masterypartners.com or check out his book, Maximize Business Value, Begin with The Exit in Mind (2020).Mastery Partners, where our mission is to equip business owners to Maximize Business Value so they can transition their business on their terms.  Our mission was born from the lessons we’ve learned from over 100 business transactions, which fuels our desire to share our experiences and wisdom so you can succeed.

How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you're always audit-ready.In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectively, within the FDA and Life Sciences division of their law firm, King & Spalding LLC.Listen to this episode where Steven and Eric share their keen insights and knowledge from working in the global regulatory sector of the medical device industry and offer best practices and tips that will help you prepare for FDA inspections and other audit events.

Since the COVID-19 pandemic started over a year ago, businesses have learned that constant change is the new normal. There will always be outside forces that companies need to adapt to, many of which are unforeseen, and there’s a continual need for resilience. One of the things that MasterControl customers have noticed is how going digital and using our solutions helps them when these issues arise. They can communicate more effectively, keep their operations going, and maintain quality with minimal interruption. We’ve already moved our customers from paper to digital — now we’re focused on data intelligence. Data intelligence is all about using artificial intelligence (AI) and machine learning (ML) to make data-driven decisions. Or, in some cases, simply enabling the applications to make those decisions without human involvement. This level of connectivity brings quality into every part of your organization, giving you a true culture of quality. Key takeaways from this session include: How common quality pains are solved by digitizing. How a connected platform allows improved agility/resilience. The benefits of connecting quality data and using it to drive decision-making. How a culture of quality driven by connected data and metrics can help your business thrive.

Matt shares his deep and valuable experience with us from testing pharmaceutical compounds and understanding the mechanics of the universe on an atomic level through implementing truly practical quality systems that help teams work more productively without weighing them down in paperwork and bureaucracy. Learn more about his work by visiting PSN’s website.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at https://teampipeline.us

Welcome back to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. In this episode our Risk Revolution team, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around risk curious concept, and expand into the why’s and why not’s and the views of this practice under PICs. The group also reviews the need for training and development around risk, formalization of a risk management process, a top-down approach to building culture, and the need for critical thinking and risk-based decision making.  Links to Risk Revolution Takeaways:The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-managementKnowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledgeLink to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin. Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the  Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level. Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics. Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Mohammed Murad, of Dubai, United Arab Emirates (UAE), is an entrepreneur and manages four companies. After a 20-year career with the Dubai Police force, he retired as a Lt. Colonel in 2003. He has more than 27 years of experience as Director and CEO in the fields of Emergency Medical Services Management, Human Resource Development and Strategic Planning all in the Government of Dubai. During his career in Dubai Police, he worked in the Criminal Investigation Department for eight years and then spearheaded the team that established and developed the Emergency Medical services for Dubai. After his retirement from the police he was tasked with heading Dubai’s Institute for Human Resource Development as CEO. He then became the Chief for Excellence and Performance in the newly established Community Development Authority for Dubai Government, where along with the strategic development team laid down the strategic plan and structure of the entity and successfully launched the Authority through a Decree. He has served as a Past International President of Toastmasters International (a non-profit organization for Leadership and Communication skills development) in 2014-15 with more than 360,000 members worldwide. Mohammed is currently the Managing Director of companies in the fields of event management, management consultancy and training, fashion and beauty. He is a lecturer in Event Management Development Institute Dubai (EMDI). Mohammed has extensive experience in Quality Systems, Coaching and Leadership Development with a multi-national workforce in the private sector. He is an entrepreneur, a consultant and a trainer. He is a certified Facilitator for MTA Experiential Learning. He is also a Certified Health Coach through the Institute of Integrative Nutrition (IIN). He holds two Masters degrees, an MBA and a Masters in Quality Management (MQM) both from the University of Wollongong, Australia.

Are you prepared for the aftermath of the pandemic's impact on the medical device industry? It may be time for device professionals to start bracing for a new normal. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that's expected to take shape from 2021 onward. Steven, a former FDA deputy associate commissioner and COO for the agency's Office of Regulatory Affairs currently serves alongside Eric as the Quality Systems and Compliance lead consultants in the FDA and Life Sciences practice of their law firm. With more than 50 years of combined industry experience between Steven and Eric, the insights and knowledge of this episode's guests, specifically as it relates to this topic is a MUST listen for any medical device professional. Some of the highlights of the show include: Steven and Eric discuss how COVID is pushing the FDA toward a voluntary pilot program for agency investigators to conduct virtual facility inspections. Steven describes the current state of FDA inspections as challenging to work remotely and conduct follow-ups when appropriate. The FDA has established a paradigm to continue on-site mission critical inspections. Eric expands on the logistical challenge for inspections by explaining that since the FDA has put a hiatus on its inspection scheme, many organizations are following the Medical Device Single Audit Program (MDSAP). The Medical Device Coordination Group's (MDCG) 2020-4 Guidance lists four circumstances where organizations under MDSAP or EU notified bodies have remote audits—surveillance, re-certification, change notification, and termination. Impact of the Emergency Use Authorization (EUA) program and the influx of requests on FDA. Some EUA submissions require pre-approval inspections. Before EUAs are revoked, build a remediated QMS, prepare for inspection, and decide whether to continue manufacturing a product after the pandemic. King & Spalding's FDA and Life Sciences team offers a full-service approach, including cardiologists to help with health assessment risks, premarket and postmarket mergers and acquisitions, and warning letters. Pre-submission is an initial but formal way to build communication, collaboration with the FDA. A pre-submission can be an effective means for understanding regulatory requirements.

Welcome to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. On this episode our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, covering some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from here time as an agent at MHRA. Links to Risk Revolution Takeaways:The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-managementKnowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledgeLink to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin. Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the  Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level. Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics. Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

Trilion Quality Systems offers optical testing and metrology systems, as well as advanced consulting engineering services across North America, and with Great Lakes Offices in Southfield, nearby Detroit. Their systems and services provide optical measurements that are a dream tool for engineers in design and manufacturing, especially in the aerospace, automotive, microelectronics, biomechanics and civil industries. In this episode, KB connects with John Tyson, President of Trilion Quality Systems and a member of Aerospace Industry Association of Michigan, to discuss all this and more!

Trilion Quality Systems offers optical testing and metrology systems, as well as advanced consulting engineering services across North America, and with Great Lakes Offices in Southfield, nearby Detroit. Their systems and services provide optical measurements that are a dream tool for engineers in design and manufacturing, especially in the aerospace, automotive, microelectronics, biomechanics and civil industries.In this episode, KB connects with John Tyson, President of Trilion Quality Systems and a member of Aerospace Industry Association of Michigan, to discuss all this and more!

This week, Stacey is joined by Lori Richter and Nuala Calnan to talk about risk management and quality management. This is the first episode in the QRM Corner series. We will cover some of the basics of Quality Risk Management in today’s episode and subsequently move on to “deep dives” focused on some of the more intricate and nuanced areas of Risk Management in future episodes.• ICH Q9 Quality Risk Management Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management • Annex 1 Manufacture of Sterile Medicinal Products: https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf • WHO Risk Management Guidance: https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2TRS-981.pdf?ua=1 • European Medicines Agency Risk Management Guidance Format: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf • European Medicines Agency Risk Management Plans: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin.Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

In this episode, Stacey is joined by Lori Richter and James Vesper. They talk about Adult Learning Theory and its impact on corporate training. Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin. Lori Richter’s Articles On The Topic:Understanding Adult Learning Principles, CGMP Training Modalities ...Applying Adult Learning Principles In CGMP TrainingBuilding Effective CGMP Training Designed For The Adult Learner James Vesper has worked in the pharmaceutical industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading the GMP training initiative. For 24 years, he was President of Learning Plus, a training consultancy and, in 2017, he joined ValSource as Director of Learning Services. Dr. Vesper has authored numerous books, book chapters, articles, and also speaks and teaches at international conferences and workshops, as well as consults for the World Health Organization (WHO). He received his PH.D. in education from Murdoch University, Perth, Australia. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.

"You can't be afraid of change. What you look like at $750,000 is not what you're going to look like at $2 million.”Being an entrepreneur isn't easy, so having a partner can be an essential component to success. Brittany Stovall and Paulina Sandoval founded Assured Quality Systems with one goal in mind: give manufacturers a faster, better, more cost-effective process for ensuring manufacturing quality. AQS is committed to not being a staffing company that dispatches “warm bodies” to a manufacturing site, but rather a crew of quality assurance professionals who have been meticulously screened, vetted and trained to miss no detail and waste no time. Prior to the founding of AQS, Brittany served as liaison representative for TRW Automotive and as director of operations at the Private Company. Before AQS, Paulina served as VP at the Private Company in San Antonio.What are the challenges of working with a partner? And how do mentors play a role? Learn more about Assured Quality Systems at assuredqualitysystems.comLearn more about Chanel Christoff Davis at www.ddhtax.com or on social media @SalesTaxHelp @FollowTheLeaderPodOutro music: "Everyday Sunshine" by aneleh

"You can't be afraid of change. What you look like at $750,000 is not what you're going to look like at $2 million.”Being an entrepreneur isn't easy, so having a partner can be an essential component to success. Brittany Stovall and Paulina Sandoval founded Assured Quality Systems with one goal in mind: give manufacturers a faster, better, more cost-effective process for ensuring manufacturing quality. AQS is committed to not being a staffing company that dispatches “warm bodies” to a manufacturing site, but rather a crew of quality assurance professionals who have been meticulously screened, vetted and trained to miss no detail and waste no time. Prior to the founding of AQS, Brittany served as liaison representative for TRW Automotive and as director of operations at the Private Company. Before AQS, Paulina served as VP at the Private Company in San Antonio.What are the challenges of working with a partner? And how do mentors play a role? Learn more about Assured Quality Systems at assuredqualitysystems.comLearn more about Chanel Christoff Davis at www.ddhtax.com or on social media @SalesTaxHelp @FollowTheLeaderPodOutro music: "Everyday Sunshine" by aneleh

Roxanne Dubois has represented medical device companies as the primary liaison with the FDA and Notified Bodies for over 25 years. Roxanne forms collaborative working relationships with representatives of regulatory agencies to obtain clearance/approval for 510(k)s, IDEs, PMAs, and Design Dossiers for new medical devices and device modifications. Roxanne has hands-on experience writing regulatory applications (including three Original PMAs), responding to Agency questions and meeting in-person and by teleconference with FDA representatives. Roxanne’s experience also includes initiation of Quality Systems for start-ups, approval of new manufacturing facilities and facilitating on-site inspections by Regulatory Agencies (QSR, BIMO, pre-PMA, new facility and inspections by Notified Bodies and a Competent Authority). While mostly focused on Regulatory and Quality, she also has experience with Clinical Affairs and combination products.Roxanne has served as the VP of Regulatory Affairs and Quality at SI-BONE, VP of Regulatory Affairs at Tenaxis Medical, VP Regulatory Affairs and Quality Assurance at Carbylan BioSurgery, Inc., VP Regulatory Affairs, Clinical Research and QA at ReGen Biologics and also as the Director of Regulatory Affairs at several mid-sized companies including Kyphon, Collagen Corporation and Cohesion Technologies. She has also consulted for medical device companies in a variety of fields such as orthopedic, gastroenterology, women’s health, dental and cosmetic surgery. Roxanne has a Bachelor of Science in Biochemistry from Cal Poly, San Luis Obispo.Roxanne's Contact information:m: 408-828-5019e: rduboisconsulting@gmail.com

I first interviewed Weber Stibolt in episode 92, when he was a Quality Assurance Specialist at Eight O Clock Coffee. A couple of years later, he’s now at one of the most talked-about food startups at the moment: Beyond Meat. The last interview we’ve had from Beyond Meat was episode 24 with one of their food engineers so it’s good to get an update on what’s happening there. So I ask Weber about his transition over there. From applying to the job, moving to the new town, and progressing through the ranks. We talk a lot about one of our favorite programs in IFT, the Emerging Leader’s Network as we were both participants in it. Weber went a little bit farther and became a peer mentor. Probably the best part of this interview was that Weber made his role by presenting a need and making a case. This is a great example that if you’re in the right company, and if you can identify a potential opportunity, you can actually carve out your own unique path. Show Notes A year ago, I was working in coffee and I got an opportunity to work at Beyond Meat Central Missouri Emerging Leader’s Network – Weber and I were in it and Weber became a peer mentor for it Emotional Intelligence How do you learn Emotional Intelligence?: The firs step is to recognize it and use it as a tool to help you move forward Did you seek this job or did you find it interesting: More the former. Coffee is a bit boring because it lacks a challenge. I wanted a better problem solving canvas. There wasn’t enough growth in my abilities. Beyond Meat IPO Was there a change when Beyond Meat went IPO?: Not really. The mission was the same. What is the difference between measuring the quality of Beyond Meat versus the quality of coffee?: Surprisingly, sensory is still a huge part of my day What notes do you look for?: On a flavor perspective, it’s fairly neutral. Nothing on the realm on pungent. Moisture and texture are important too. Oil is also important Small changes can have a fairly big impact. Adding an extra lb of flavoring for example, will affect a lot. What about raw material?: We actually are very happy with our pea protein lots. However, two different manufacturers can be totally different PURIS – suppliers in Beyond Meat Quality Systems Manager: Making paperwork digital Kelly Wilson – VP of quality Gallup Personality Test SQF Conference guy about risk IF I leave a beyond meat in the fridge, would it rot as regular meat?: Technically it’s less risky Why Does Your Food Job Rock?: I’m doing so many cool things in Beyond Meat Trends and technology: We spend a significant amount of money on R+D Plant-based fried chicken in KFC is super convincing It’s made of wheat and soy What is one thing in the industry that you’re interested about?: Cell-cultured meat Clean Meat by Paul Shapiro My podcast case is politics and a few comedy podcasts like Mark Marron’s pocast Any advice on switching roles?: Change Management is extremely important. Every single job has a  change management component Where can find we find you?: LinkedIn’s the best  

The City of Lethbridge implemented a local state of emergency on March 18, 2020 and is working with community partners to identify areas of need for the community during the COVID 19 pandemic. 16 subcommittees have been formed to address and support the community while this crisis is unfolding. Action taken so far include working closely with Alberta Health Services and the agencies that serve our vulnerable populations to ensure these groups have the needed housing, health care and other supports they require. Other measures include free transit, 90 day utility payment deferrals and property tax options. All City facilities, including City Hall, Fire Stations, Lethbridge Transit, all recreation and culture facilities (pools, arenas, Lethbridge Public Library branches, Galt Museum and the Helen Schuler Nature Centre) are closed to the public until further notice. Lethbridge Police Service have closed public access to their building until further notice as have Lethbridge Animal Shelter. The speaker will unpack many of the safety steps that have been made to address this dangerous pandemic and whether or not more measures may be needed. Speaker: Chris Spearman, Mayor of Lethbridge Along with 38 years of business experience, Chris Spearman devoted 18 years (1992-2010) to serving on the Holy Spirit School Board which included two terms as Board Chair. He is a founding member of the Industrial Association of Southern Alberta, established in 1983. Chris is passionate about environmental issues, supports practical solutions and believes in continuous improvement. His employment experience includes 10 years working with the ISO 14001 Environmental Management System and 13 years with ISO 9002 Quality Systems. Chris was a member of the Lethbridge Chamber of Commerce since 2008 and served on several sub-committees. In addition, he served five years (2008-2013) on University of Lethbridge Faculty of Management Advisory Committee. From 2010 to 2013 he served as a board member for the Aboriginal Housing Society. Chris has also volunteered with several other community organizations including Economic Development Lethbridge (a founding member) and the Rehabilitation Society of Southwestern Alberta (now known as the Ability Resource Centre). Date and time: Thursday, April 9, 2020 at 10 am YouTube Live link: https://youtu.be/s8zuiIKU9Nw In order to ask questions of our speaker in the chat feature of YouTube, you must have a YouTube account and be signed in. Please do so well ahead of the scheduled start time, so you'll be ready. Go the YouTube Live link provided in this session flyer and on the top right of your browser click the “sign in” button. If you have Google or Gmail accounts, they can be used to sign in. If you don't, click “Create Account” and follow along. Once you are signed in, you can return to the live stream and use the chat feature to ask your questions of the speaker. Remember you can only participate in the chat feature while we are livestreaming.

The City of Lethbridge implemented a local state of emergency on March 18, 2020 and is working with community partners to identify areas of need for the community during the COVID 19 pandemic. 16 subcommittees have been formed to address and support the community while this crisis is unfolding. Action taken so far include working closely with Alberta Health Services and the agencies that serve our vulnerable populations to ensure these groups have the needed housing, health care and other supports they require. Other measures include free transit, 90 day utility payment deferrals and property tax options. All City facilities, including City Hall, Fire Stations, Lethbridge Transit, all recreation and culture facilities (pools, arenas, Lethbridge Public Library branches, Galt Museum and the Helen Schuler Nature Centre) are closed to the public until further notice. Lethbridge Police Service have closed public access to their building until further notice as have Lethbridge Animal Shelter. The speaker will unpack many of the safety steps that have been made to address this dangerous pandemic and whether or not more measures may be needed. Speaker: Chris Spearman, Mayor of Lethbridge Along with 38 years of business experience, Chris Spearman devoted 18 years (1992-2010) to serving on the Holy Spirit School Board which included two terms as Board Chair. He is a founding member of the Industrial Association of Southern Alberta, established in 1983. Chris is passionate about environmental issues, supports practical solutions and believes in continuous improvement. His employment experience includes 10 years working with the ISO 14001 Environmental Management System and 13 years with ISO 9002 Quality Systems. Chris was a member of the Lethbridge Chamber of Commerce since 2008 and served on several sub-committees. In addition, he served five years (2008-2013) on University of Lethbridge Faculty of Management Advisory Committee. From 2010 to 2013 he served as a board member for the Aboriginal Housing Society. Chris has also volunteered with several other community organizations including Economic Development Lethbridge (a founding member) and the Rehabilitation Society of Southwestern Alberta (now known as the Ability Resource Centre). Date and time: Thursday, April 9, 2020 at 10 am YouTube Live link: https://youtu.be/s8zuiIKU9Nw In order to ask questions of our speaker in the chat feature of YouTube, you must have a YouTube account and be signed in. Please do so well ahead of the scheduled start time, so you'll be ready. Go the YouTube Live link provided in this session flyer and on the top right of your browser click the “sign in” button. If you have Google or Gmail accounts, they can be used to sign in. If you don't, click “Create Account” and follow along. Once you are signed in, you can return to the live stream and use the chat feature to ask your questions of the speaker. Remember you can only participate in the chat feature while we are livestreaming.

On this week’s podcast, executive editor Shawn M. Schmitt shares expert tips and advice on how device makers can integrate the recently revised international risk management standard ISO 14971 into their quality systems. Medtech Insight articles addressing topics discussed in this episode: • Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971 • Crosswalk: ISO 14971:2007 Vs. ISO 14971:2019

Today on Awake and On Purpose, leadership expert Deborah Coviello shares how she transitioned from a position in corporate America into entrepreneurship by listening to her own instincts and signs from the universe. Join Jennifer and Deborah as they discuss taking time to transition, identifying the work you love, and the importance of mentorship and outside perspective when following a career path. Deborah applies expert knowledge, industry experience, and relentless energy to solving your company’s issues. Deborah began her career at Raytheon Company where she was selected to participate in their Manufacturing Management Development Program leading up to a role as a Quality Systems and Planning Manager in Operations. Over the next 20+years, in Quality and Operational Excellence roles she has produced brilliant results in Electronics, Consumer Communications, Data Communications.  Deborah has spent the last 15 years specialized in the Food, Chemical, Flavors & Fragrances Industries. As a Quality & Operational Excellence Executive she thrives in Rapidly Changing Organizations in establishing Stability, Increasing Team Capability through Teaching & Coaching and Leading Organizations by establishing Strategy aligned to Organizational Vision. You can connect with Deborah in the following ways: https://www.dropinceo.com/ https://www.linkedin.com/in/deborahacoviello/  https://twitter.com/DropinCEO https://www.facebook.com/IlluminationPartnersLLC/ https://www.instagram.com/dropinceo/  To learn more about how you can connect to your higher purpose and take that leap of faith to make your impact in the world, visit us at www.jenniferspor.com.

In this episode, Hiran Banerjee talks about what we look for when hiring a Quality Control (QC) Person. He discusses about Quality Systems, adaptability, efficiency, checking plagiarism, grammar, checking the quality of the content to make sure it meets the guidelines, and more. You can email us your questions at desk@qaquizzy.com quizzy.co.in

Do you know the difference between quality management system (QMS) and quality systems management (QSM)? Today's guest is Larry Mager of Mgmt-Ctrl. He describes the difference between QMS and QSM, as well as offers tips on concepts that make medical device businesses more efficient and effective to benefit patients. Some of the highlights of the show include: ● Challenges with management control include the different definitions of quality management. Most organizations define it too narrowly and passively. ● QMS documents processes, procedures, and responsibilities to achieve quality policies/objectives. ● For Mgmt-Ctrl, QMS includes quality operations and QSM. The QSM solution is designed to measure, manage, and improve the quality of products/processes. ● Companies focus more on compliance than quality due to costs. Predictive analytics extract info from data to find patterns that may predict outcomes. ● Company's executive team and person responsible for regulatory compliance (PRRC) are responsible for measuring and confirming process/product quality. ● Medical device companies need to be proactive, not reactive. And, they need to understand management control terminology, such as product and process. ● Design and development process has not focused on critical quality controls or reviewed released products against those controls to make adjustments. ● A medical device that's a software component must be controlled and managed appropriately within a quality system.

Jim Moran is the Co-Founder and President of SimplifyISO. Jim and his team have been helping organizations simplify their quality management systems since 1992.Just in case you thought that Jim's name sounds familiar, he was our very first guest (Episode 1001) on the SuccessInsight Podcast way back in February. He joined us again in Episode 1023, where we chatted quite a lot about ISO Quality Standards and Leadership.Jim invites you to follow him on his website at www.simplifyiso.com.You can click here to learn more about Jim’s ISO 2001:2015 Essentials Training Program.Jim also invites you to connect with him on LinkedIn and to follow him on YouTube.Link to Success InSight Podcast: https://www.successinsightpodcast.com/2019/10/jim-moran-simplifyiso.html

Now that Lethbridge is a city of more than 100,000 inhabitants, there are some perceived “big city” problems that go along with it. Actually, we have had many of them all along, but with a larger population they become more visible. With the Federal election looming in less than a week and a Provincial budget to be unveiled shortly after, the intergovernmental effects on Lethbridge could be substantial and will need unpacking. This year has proven to be a bright spot in the form of grand openings for major capital improvement projects, economic development and the progress being made on revitalizing the Downtown. Aside from the nation-wide substance abuse concerns and the progress being made with the Clean and Safe Strategy, there are a number of challenges and opportunities our Mayor and Council welcome each new week. Come and hear what's at the top of our Mayor's list this week. Speaker: Chris Spearman, Mayor of Lethbridge Along with 38 years of business experience, Chris Spearman devoted 18 years (1992-2010) to serving on the Holy Spirit School Board which included two terms as Board Chair. He is a founding member of the Industrial Association of Southern Alberta, established in 1983. Chris is passionate about environmental issues, supports practical solutions and believes in continuous improvement. His employment experience includes 10 years working with the ISO 14001 Environmental Management System and 13 years with ISO 9002 Quality Systems. Chris was a member of the Lethbridge Chamber of Commerce since 2008 and served on several sub-committees. In addition, he served five years (2008-2013) on the University of Lethbridge Faculty of Management Advisory Committee. From 2010 to 2013 he served as a board member for the Aboriginal Housing Society. Chris has also volunteered with several other community organizations including Economic Development Lethbridge (a founding member) and the Rehabilitation Society of Southwestern Alberta (now known as the Ability Resource Centre). As the father of four adult children and proud grandpa of six grandchildren, Chris loves spending time with his family, particularly when they gather for special occasions such as Easter, Thanksgiving, Christmas and family birthdays. His leisure activities include skiing, walking in our city parks and biking our trails. He enjoys travel and appreciates cultural diversity. Moderator: Dr. Bev Muendel-Atherstone Date: Thursday, October 17, 2019 Time: Doors open 11:30 am, Presentation 12 noon, buffet lunch 12:30 pm, Q&A 1 – 1:30 pm Location: Royal Canadian Legion (north door) 324 Mayor Magrath Dr. S. Lethbridge Cost: $14 buffet lunch with dessert/coffee/tea/juice or $2 coffee/tea/juice. RSVP not required Visit the SACPA website: http://www.sacpa.ca

Now that Lethbridge is a city of more than 100,000 inhabitants, there are some perceived “big city” problems that go along with it. Actually, we have had many of them all along, but with a larger population they become more visible. With the Federal election looming in less than a week and a Provincial budget to be unveiled shortly after, the intergovernmental effects on Lethbridge could be substantial and will need unpacking. This year has proven to be a bright spot in the form of grand openings for major capital improvement projects, economic development and the progress being made on revitalizing the Downtown. Aside from the nation-wide substance abuse concerns and the progress being made with the Clean and Safe Strategy, there are a number of challenges and opportunities our Mayor and Council welcome each new week. Come and hear what's at the top of our Mayor's list this week. Speaker: Chris Spearman, Mayor of Lethbridge Along with 38 years of business experience, Chris Spearman devoted 18 years (1992-2010) to serving on the Holy Spirit School Board which included two terms as Board Chair. He is a founding member of the Industrial Association of Southern Alberta, established in 1983. Chris is passionate about environmental issues, supports practical solutions and believes in continuous improvement. His employment experience includes 10 years working with the ISO 14001 Environmental Management System and 13 years with ISO 9002 Quality Systems. Chris was a member of the Lethbridge Chamber of Commerce since 2008 and served on several sub-committees. In addition, he served five years (2008-2013) on the University of Lethbridge Faculty of Management Advisory Committee. From 2010 to 2013 he served as a board member for the Aboriginal Housing Society. Chris has also volunteered with several other community organizations including Economic Development Lethbridge (a founding member) and the Rehabilitation Society of Southwestern Alberta (now known as the Ability Resource Centre). As the father of four adult children and proud grandpa of six grandchildren, Chris loves spending time with his family, particularly when they gather for special occasions such as Easter, Thanksgiving, Christmas and family birthdays. His leisure activities include skiing, walking in our city parks and biking our trails. He enjoys travel and appreciates cultural diversity. Moderator: Dr. Bev Muendel-Atherstone Date: Thursday, October 17, 2019 Time: Doors open 11:30 am, Presentation 12 noon, buffet lunch 12:30 pm, Q&A 1 – 1:30 pm Location: Royal Canadian Legion (north door) 324 Mayor Magrath Dr. S. Lethbridge Cost: $14 buffet lunch with dessert/coffee/tea/juice or $2 coffee/tea/juice. RSVP not required Visit the SACPA website: http://www.sacpa.ca

Now that Lethbridge is a city of more than 100,000 inhabitants, there are some perceived “big city” problems that go along with it. Actually, we have had many of them all along, but with a larger population they become more visible. With the Federal election looming in less than a week and a Provincial budget to be unveiled shortly after, the intergovernmental effects on Lethbridge could be substantial and will need unpacking. This year has proven to be a bright spot in the form of grand openings for major capital improvement projects, economic development and the progress being made on revitalizing the Downtown. Aside from the nation-wide substance abuse concerns and the progress being made with the Clean and Safe Strategy, there are a number of challenges and opportunities our Mayor and Council welcome each new week. Come and hear what's at the top of our Mayor's list this week. Speaker: Chris Spearman, Mayor of Lethbridge Along with 38 years of business experience, Chris Spearman devoted 18 years (1992-2010) to serving on the Holy Spirit School Board which included two terms as Board Chair. He is a founding member of the Industrial Association of Southern Alberta, established in 1983. Chris is passionate about environmental issues, supports practical solutions and believes in continuous improvement. His employment experience includes 10 years working with the ISO 14001 Environmental Management System and 13 years with ISO 9002 Quality Systems. Chris was a member of the Lethbridge Chamber of Commerce since 2008 and served on several sub-committees. In addition, he served five years (2008-2013) on the University of Lethbridge Faculty of Management Advisory Committee. From 2010 to 2013 he served as a board member for the Aboriginal Housing Society. Chris has also volunteered with several other community organizations including Economic Development Lethbridge (a founding member) and the Rehabilitation Society of Southwestern Alberta (now known as the Ability Resource Centre). As the father of four adult children and proud grandpa of six grandchildren, Chris loves spending time with his family, particularly when they gather for special occasions such as Easter, Thanksgiving, Christmas and family birthdays. His leisure activities include skiing, walking in our city parks and biking our trails. He enjoys travel and appreciates cultural diversity. Moderator: Dr. Bev Muendel-Atherstone Date: Thursday, October 17, 2019 Time: Doors open 11:30 am, Presentation 12 noon, buffet lunch 12:30 pm, Q&A 1 – 1:30 pm Location: Royal Canadian Legion (north door) 324 Mayor Magrath Dr. S. Lethbridge Cost: $14 buffet lunch with dessert/coffee/tea/juice or $2 coffee/tea/juice. RSVP not required Visit the SACPA website: http://www.sacpa.ca

Now that Lethbridge is a city of more than 100,000 inhabitants, there are some perceived “big city” problems that go along with it. Actually, we have had many of them all along, but with a larger population they become more visible. With the Federal election looming in less than a week and a Provincial budget to be unveiled shortly after, the intergovernmental effects on Lethbridge could be substantial and will need unpacking. This year has proven to be a bright spot in the form of grand openings for major capital improvement projects, economic development and the progress being made on revitalizing the Downtown. Aside from the nation-wide substance abuse concerns and the progress being made with the Clean and Safe Strategy, there are a number of challenges and opportunities our Mayor and Council welcome each new week. Come and hear what's at the top of our Mayor's list this week. Speaker: Chris Spearman, Mayor of Lethbridge Along with 38 years of business experience, Chris Spearman devoted 18 years (1992-2010) to serving on the Holy Spirit School Board which included two terms as Board Chair. He is a founding member of the Industrial Association of Southern Alberta, established in 1983. Chris is passionate about environmental issues, supports practical solutions and believes in continuous improvement. His employment experience includes 10 years working with the ISO 14001 Environmental Management System and 13 years with ISO 9002 Quality Systems. Chris was a member of the Lethbridge Chamber of Commerce since 2008 and served on several sub-committees. In addition, he served five years (2008-2013) on the University of Lethbridge Faculty of Management Advisory Committee. From 2010 to 2013 he served as a board member for the Aboriginal Housing Society. Chris has also volunteered with several other community organizations including Economic Development Lethbridge (a founding member) and the Rehabilitation Society of Southwestern Alberta (now known as the Ability Resource Centre). As the father of four adult children and proud grandpa of six grandchildren, Chris loves spending time with his family, particularly when they gather for special occasions such as Easter, Thanksgiving, Christmas and family birthdays. His leisure activities include skiing, walking in our city parks and biking our trails. He enjoys travel and appreciates cultural diversity. Moderator: Dr. Bev Muendel-Atherstone Date: Thursday, October 17, 2019 Time: Doors open 11:30 am, Presentation 12 noon, buffet lunch 12:30 pm, Q&A 1 – 1:30 pm Location: Royal Canadian Legion (north door) 324 Mayor Magrath Dr. S. Lethbridge Cost: $14 buffet lunch with dessert/coffee/tea/juice or $2 coffee/tea/juice. RSVP not required Visit the SACPA website: http://www.sacpa.ca

Podcast

Podcast

"Kyle Hooper with Volvo Cars: Driving Growth in South Carolina” Supply Chain Now Radio, Episode 167 Live from the 2019 SCAC AIAG Supply Chain & Quality Conference in Charleston, South Carolina Episode 167 of SCNR features Kyle Hooper. W. Kyle Hooper, MBA, CQE, CQA, LSSGB is the Manager of Procurement and SQM Excellence for Volvo Cars in North and South America. His responsibilities include: Procurement Sustainability, Digitalization, Process Management, and Training. Kyle brings over 15 years of experience working with complex supply chains and supplier development in the automotive and aerospace industries. Prior to joining Volvo, Kyle was the Manager of Supplier Development and Quality Systems at Enovation Controls who is a tier one automotive supplier producing on and off road electronic instrumentation in Tulsa, OK. In this role he was responsible for supplier development in North America, TS 16949 certification, and the deployment of a product lifecycle management system at five global locations. Additionally, Kyle has worked as a Supplier Quality Manager at Frontier Electronic Systems in the aerospace sector that provided high reliability electronic assemblies to Boeing, Lockheed Martin, Raytheon, and NASA. He earned a Bachelor of Science degree in Economics from Oklahoma State University. He also received a Master’s of Business Administration degree from Oklahoma Christian University. Kyle holds several quality certifications from the American Society of Quality (ASQ) which includes: Certified Quality Engineer, Certified Quality Auditor, and Lean Six Sigma Green Belt. Learn more about Volvo Cars here: https://www.volvocars.com/us Upcoming Events & Resources Mentioned in this Episode: Help with Hurricane Dorian Relief: https://www.alanaid.org/ Connect with Kyle on LinkedIn: https://www.linkedin.com/in/w-kyle-hooper-mba-cqe-cqa-cssgb-b6755a27/ Connect with Beau on LinkedIn: https://www.linkedin.com/in/beaugroover/ Connect with Scott on LinkedIn: https://www.linkedin.com/in/scottwindonluton/ Georgia Manufacturing Summit on October 9th: https://www.georgiamanufacturingalliance.com/annual-summit SCNR to Broadcast Live at SC Logistics 2019 Fall Tech Talk: https://tinyurl.com/y2mttrg8 eft Logistics CIO Forum in Austin, TX: https://tinyurl.com/y5po7tvw Reverse Logistics Association Conference & Expo: https://rla.org/calendar/1 SCNR to Broadcast Live at MODEX 2020: https://www.modexshow.com/ SCNR on YouTube: https://tinyurl.com/scnr-youtube Check Out News From Our Sponsors: The Effective Syndicate: https://www.theeffectivesyndicate.com/blog APICS Atlanta: https://apicsatlanta.org TalentStream: https://talentstreamstaffing.com/ Verusen: https://www.verusen.com/ Georgia Manufacturing Alliance: https://www.georgiamanufacturingalliance.com/ ProPurchaser.com: https://tinyurl.com/y6l2kh7g Supply Chain Real Estate: https://supplychainrealestate.com/ Vector Global Logistics: http://vectorgl.com/ This episode was hosted by Greg White, Scott Luton, and Beau Groover of the Effective Syndicate. For more information, please visit our dedicated show page at: www.supplychainnowradio.com/episode-167

In this episode, we talk with Dr. Alecia Gabriel of P3 Group North America. Dr. Gabriel serves as the Quality Systems Consultant and brings her experience in project management, automotive and aerospace quality assurance, and automotive consulting to our healthcare platform to talk Failure Modes and Effects Analysis (FMEA). In this first installment of our Beyond Healthcare Quality segment, Alecia will share an outsider view of a powerful quality improvement methodology, the potential that it holds for transforming healthcare, and why its appropriate application and execution should be a key part of your organizational high-reliability strategy.

Mary Beth Henderson is the VP of Regulatory Affairs and Quality Systems at Regulatory and Clinical Research Institute, Inc. She holds a B.A. in Chemistry from Gustavus Adolphus College, an M.S. and Ph.D. in Chemistry from Northwestern University, and an MBA...

#SuccessInSight is pleased to introduce Jim Moran, MA Ed., Founder, Simplify ISO Inc. Jim has been helping organizations simplify their management systems since 1992. Today, he shows small and medium-size how to build a management system that’s easy to use and effective, and will enable them to satisfy Standards requirements, client requirements and any other requirements that need to be met.You can learn more about Jim and his work at https://simplifyiso.com.Please visit https://successinsightpodcast.com to read the full transcript of this episode and to listen to more selections and read the transcripts from the podcast library.

What is going on in the medical device industry right now that is driving companies and the FDA to address quality systems differently? What is the Quality Systems Management (QSM) Strategic Plan? How will it help organizations? How will it help patients? Larry Mager is an experienced medical device quality executive with success in taking quality management systems to the next level at major global medical device companies. He now is leveraging his decades of leadership and making his system available for any organization that wants or needs to improve. Quality System(s) Management (QSM) = Measure | Manage | Improve 1. A Quality System(s) Management (QSM) plan is utilized to measure, manage, and improve the ‘quality' of an organization's Quality Management System (QMS) 2. QSM measures what matters in regard to product and process quality, and does so in a manner that is actionable for Management 3. QSM enables the strategic understanding of product & process ‘quality', as is expected of Management by the stakeholders 4. QSM targets issues of constraint, enabling the responsible and targeted improvement of the organization's constraints 5. Supports EU MDR and Case for Quality initiatives (see below) EU MDR defines significant responsibilities associated with the verification of product & process ‘quality' through the PMS & QMS surveillance activities utilized within a medical device company. The accountability for doing so resides within the designated role of Person Responsible for Regulatory Compliance (PRRC). The capability to satisfy the obligations of that role must be ‘built' into the Quality Management System (QMS). The Case for Quality is an FDA-driven initiative, coordinated in partnership with the Medical Device Innovation Consortium (MDIC) and in collaboration with the Medical Device Industry, focused on creating “sustained predictive practices that advance medical device quality and safety.” To connect with Larry: info@mgmt-ctrl.com  

Do you know the difference between quality management system (QMS) and quality systems management (QSM)? Today’s guest is Larry Mager of Mgmt-Ctrl. He describes the difference between QMS and QSM, as well as offers tips on concepts that make medical device businesses more efficient and effective to benefit patients. Some of the highlights of the show include: ● Challenges with management control include the different definitions of quality management. Most organizations define it too narrowly and passively. ● QMS documents processes, procedures, and responsibilities to achieve quality policies/objectives. ● For Mgmt-Ctrl, QMS includes quality operations and QSM. The QSM solution is designed to measure, manage, and improve the quality of products/processes. ● Companies focus more on compliance than quality due to costs. Predictive analytics extract info from data to find patterns that may predict outcomes. ● Company’s executive team and person responsible for regulatory compliance (PRRC) are responsible for measuring and confirming process/product quality. ● Medical device companies need to be proactive, not reactive. And, they need to understand management control terminology, such as product and process. ● Design and development process has not focused on critical quality controls or reviewed released products against those controls to make adjustments. ● A medical device that’s a software component must be controlled and managed appropriately within a quality system.

On today’s podcast, I interviewed Albert Lettmen, a Lean Six Sigma and Quality Systems consultant and educator who has worked for decades with prominent manufacturing companies around the world. Albert grew up in Jamaica, studied business in Scotland, and then worked for companies in Europe, China, Canada and the United States. I was surprised when […]

E21 Mark Price Perry from BOT International and Donovan Hardenbrook from Littelfuse In our final 2018 episode of Project Management Office Hours Joe Pusz, PMO Joe, and his guests Mark Price Perry and Don Hardenbrook discuss the Business Driven PMO and viewing Project Management and PMOs through a business lens. Mark shares his story of […] The post E21 Mark Price Perry from BOT International and Donovan Hardenbrook from Littelfuse appeared first on Business RadioX ®.

Welcome to the eighth episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She’s joined by her co-host, the CEO and founder of Solabs, Philippe Gaudreau. The focus of this week’s show is the specificities of GCP quality systems. Mandy and Philippe are joined by special guest, Nahtalie Bourgouin, VP of Compliance at Skillpad. Skillpad is a sister company of Solabs and Philippe has had the pleasure of collaborating with Nathalie over the years. With more than 25 years of experience in pharmaceuticals and biotech in North America and Europe, Nathalie is a leader in compliance, quality, and project management, with a solid background in risk-based quality assurance processes, training, and auditing. She has planned and audited many GMP and GCP vendors, as well as numerous clinical sites in local and global studies. The conversation with Nathalie today will surely help companies improve their quality levels. Some key topics discussed today include: the difference between GMP and GCP quality systems, how Nathalie has seen the global regulatory landscape change, the key variables to consider with GCP event management, and specific tools that can be utilized to help streamline the process.   Key Takeaways: [:34] About today’s topic and guest. [1:45] Nathalie introduces herself and talks about her background in quality and compliance. [3:30] How are the GMP and GCP quality systems different? And what are the idiosyncrasies of a GCP system? [5:17] How has Nathalie seen the global regulatory landscape change? And is this driving a new approach for managing clinical event occurrence? [7:20] What Nathalie sees as a few key variables to consider (as related to GCP event management). [9:34] Nathalie explains the type of approach that can be implemented to enhance the traceability and robustness related to clinical events that occur in the field. [13:04] Are there any specific tools that can be utilized to help streamline the process? [15:53] How does Nathalie see this approach, relating to the new ICH E6 guidance, in regard to data integrity? [21:18] How to get in touch with Nathalie or Mandy. [21:54] About next week’s episode.   Mentioned in this Episode: GCP and GMP basics ICH E6 (R2) Compliance@Skillpad.com Mandy.Podcast@Solabs.com

In this SupplySide West edition of the Healthy INSIDER Podcast, Rachel Adams, managing editor, and Tara Couch, senior director of dietary supplement and tobacco services at EAS Consulting Group, discuss essential quality systems for an own label distributor in a contract manufacturing partnership.

Improving the competitiveness of Utah manufacturers through technology, innovation and operational excellence support. Specific assistance includes a focus on increasing profits through the development of new products, markets and/or customers while improving costs through process improvement and sustainability. Theresa Drulard is the Executive Director of the Manufacturing Center at the University of Utah. She has 27+ years of  experience in manufacturing, including 17 years in operations management (production). Her expertise is also in operational excellence and lean implementation in manufacturing and service, as well as Quality Systems. https://mep.utah.edu/about-us/

This interview is part of our HIMSS18 coverage. We'll be talking with thought leaders and vendors all week at the annual Health Information Management Society conference in Las Vegas. On this episode, we're talking with Dr. Betty Rabinowitz, Senior Vice President of Solutions Analytics at NextGen Healthcare. Dr. Betty Rabinowitz is one of the founders and the former CEO of EagleDream Health, the software analytics solutions company acquired by NextGen Healthcare in August, 2017. EagleDream Health comprises cloud-based analytics and population health management solutions that drive meaningful insights across clinical, financial, and administrative data to optimize ambulatory practice performance. Quality Systems, Inc., known to its clients as NextGen Healthcare, provides a range of software, services, and analytics solutions to medical and dental group practices. The company's portfolio delivers foundational capabilities to empower physician success, enrich the patient care experience, and enable the transition to value-based healthcare.  Learn more about Dr. Betty and NextGen: https://www.nextgen.com/ https://www.linkedin.com/company/nextgen-healthcare-information-systems/ https://twitter.com/NextGen https://www.nextgen.com/insights      You can checkout the rest of our HIMSS18 Interviews here. Subscribe to Weekly Updates If you like what we're doing here, then please consider signing up for our weekly newsletter. You'll get one email from me each week detailing: New podcast episodes and blog posts. Content or ideas that I've found valuable in the past week. Insider info about the show like stats, upcoming episodes and future plans that I won't put anywhere else. Plain text and straight from the heart :) No SPAM or fancy graphics and you can unsubscribe with a single click anytime. The #HCBiz Show! is produced by Glide Health IT, LLC in partnership with Netspective Media. Music by StudioEtar

No brewery is too small to take a systematic approach to quality. Gary Nicholas has some great advice for aligning your breweries priorities, data collection, and decision-making process. This week's content was curated based on a listener request.

No brewery is too small to take a systematic approach to quality. Gary Nicholas has some great advice for aligning your breweries priorities, data collection, and decision-making process. This week's content was curated based on a listener request.

Strategic well-planned remediation is paramount to long-term sustainable corrections and corrective actions. In this white paper podcast by NSF International’s Maxine Fritz, the value of a systems approach to corrective actions is discussed, highlighting the importance of the three “Cs to success”.

The lucativenes of renting. Get your AC ready for 115 degree temps.

Larry Thompson explains the problems you get when you do not do easy preventative maintenance on your AC.

Fighting Infections This week we hosted two experts whose companies are fighting infections from different directions. Michael Hellerstein is the Director of Regulatory Affairs and Quality Systems for GeoVax. They’re a biotechnology company that’s developing vaccines for Ebola and HIV. Debora Carrier combined her experience as a fashion model and a healthcare provider to think […] The post Fighting Infections appeared first on Business RadioX ®.

Sponsored by Learn tips for SPC success from Don Elmore, chief software architect at DataNet Quality Systems. Don is the inventor of a patent-pending methodology that enables quality practitioners, using statistical process control, to identify process improvements that will lower manufacturing costs. 

Lean Quality Systems, Inc. uses reverse management methods for capturing company cultures and personalities to optimize efficiencies and increase the profit margins of its clients. To guarantee customer satisfaction, organizations must produce safe and reliable products that meet or exceed customer expectations and all applicable statutory and regulatory requirements. This pertains to the manufacturing of general, medical devices, as well as the aviation, space and defense industries. The globalization of these industries, coupled with diversity of regional and national requirements, has complicated this objective. As such, these organizations are becoming increasingly challenged when it comes to purchasing products from their global supplier bases. On the flip side, these supplier bases face many difficulties associated with delivering products to multiple customers, each with varying quality standards. This is why the ISO 9001:2008 Quality Management System is used as the foundation for ISO 13458 (medical devices) and AS9100C (aviation, space and defense organizations). For more information on Lean Quality Systems, please visit our Website at http://isojoe.com.