Podcasts about quality management systems

In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions that not only ensure compliance but also drive meaningful improvement within medical device companies. With over a decade of experience, Georg brings practical knowledge on avoiding common pitfalls such as "death by CAPA" or failing to recognize high-risk systemic issues. The episode also delves into the importance of verification of effectiveness (VoE) checks, the distinctions between corrective actions and preventive actions, and how to balance a proactive approach with pragmatic solutions.Key Timestamps:[03:15] – Defining CAPA and its critical role in Quality Management Systems[10:45] – Common CAPA triggers: Balancing overuse and underuse[18:20] – Root cause analysis vs. corrective action: A step-by-step approach[25:40] – Containment vs. correction: Key differences in addressing nonconformities[38:10] – Verification of effectiveness: Best practices for ensuring long-term solutions[50:30] – Continuous improvement through CAPA: Avoiding system overload[1:00:05] – Practical tips for balancing CAPA triggers with company prioritiesMemorable Quotes:“CAPA isn't just about compliance; it's about driving real improvement in your organization." – Georg Digel“The worst thing that can happen is losing oversight on the serious issues because your system is flooded with trivial ones.” – Georg Digel“Root cause analysis isn't about fixing the symptom, it's about ensuring the issue never comes back.” – Etienne NicholsKey Takeaways:MedTech Trends:CAPA as a Key to Continuous Improvement – How CAPA systems fuel company growth by addressing both high-risk and systemic issues.Data-Driven CAPA Triggers – Integrating post-market surveillance and production data for more proactive corrective actions.Regulatory Impact on CAPA – The importance of understanding evolving regulations and their influence on product safety and quality management.Practical Tips for CAPA Implementation:Sharpen Your Triggers – Clearly define CAPA triggers to avoid flooding the system with low-risk issues.Effective VoE – Ensure VoE checks are specific to root causes, not just symptoms, for long-term success.Cross-Site CAPA Learning – Use internal audits and external findings from similar companies to prevent systemic failures across sites.Future Questions in MedTech:How will advances in AI and machine learning improve CAPA systems in the future?Can companies move toward more preventive action frameworks, or is CAPA inherently reactive?How will stricter global regulatory updates reshape CAPA strategies in medical device manufacturing?References:FDA 483 and Warning Letters Database – A resource to monitor common CAPA violations and avoid systemic errors.LinkedIn Profile - Georg Digel – Follow Georg Digel for daily insights...

Welcome to Episode 153 of The Profitable Cleaner podcast! Hosts Angel and James sit down with Mark Anderson, President of The Profit Growth Initiative and speaker at the VIP Masterclass during Cleaning Prophets. We explore the concept of business alchemy as we delve into strategies that can convert everyday operations into exceptional value. Mark's wealth of knowledge, combined with practical examples, lays out a clear road map for leveraging current customers and implementing systems to enhance business growth and profitability. We also explore the revolutionary impact of AI on business efficiency and we touch on the importance of continuous learning, networking, and events to foster community and growth. 

Mitch Robbins had the pleasure of hosting Mr. Jason Gorman, the Vice President of Regulatory, Quality & Compliance at Propeller Health for episode #105. Jason comes to us today with over 25 years of experience across the Med-Tech industry. He has a proven track record for developing & implementing Quality Management Systems, Risk Management strategies & Regulatory Compliance processes to meet the highest standards of excellence in customer satisfaction. Prior to working for Propeller Health, Jason spent over a decade working for Accuracy. For those unfamiliar with Propeller Health, now owned by Resmed, it's a precision digital health company on a mission to uplift every person living with chronic disease so they can take control of their health and live a better life. The Propeller Platform includes FDA-cleared & CE Marked medical devices, consumer apps support & coaching and secure access to clinical data for provider monitoring.Some highlights:-Jason's journey into Quality & Regulatory-The evolution of his interest & responsibilities related to privacy & security-Cybersecurity's disruption to Med-Tech in relation MDR & QMSR changes-Jason's prediction for the evolution of Reg Affairs & Quality roles with regards to Cybesecurity-The relationship between Quality Management Systems & Information Security Management Systems-Cybersecurity vs AI....what is the common thread?...and so much more!Jason Gorman on LinkedIn:https://www.linkedin.com/in/jason-c-gorman/Propeller Health on the web:www.propellerhealth.com

Welcome to the second season of "Breaking the Chain: Leading in a VUCA World"! In our eighth episode, Charmaine Reid sits down a special guest Raj Bhogan, Senior Director in Business Strategy & Operations for R&D at Jazz Pharmaceuticals, to explore the challenges and strategies for navigating complexity in leadership roles. With over two decades of diverse experience in the pharmaceutical industry, Raj brings a wealth of knowledge to the table, particularly in Quality Management Systems and operations.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!

For his second episode in this series of conversations Peter is joined by highly experienced Qualified Person Graham Saunders to share insights he has gleaned across his rich and varied career.   Graham has worked within some of the biggest Pharma companies around, covering commercial, IMP GMP's and API's. His auditing experience is equally as impressive, conducting audits all across the world within all quality areas and Quality Management Systems.   In this wide ranging conversation, Graham talks about how he got his start in auditing and how his varied learning experiences shaped and propelled his career in Pharmaceutical Quality.   He also shares some illuminating stories from both internal and external audits he has been involved in - shining a light on what is a surprisingly varied skillset required for a pharmaceutical auditor to excel in their role.   Want to join Graham in becoming a pharmaceutical auditor? From nurturing early-career talent, to fostering continuous professional development (CPD), RSSL provides you with a comprehensive auditing career path giving you a powerful platform to propel your career further: https://www.rssl.com/training-consultancy/auditing-career-path-training-programme/

In this episode, join Dr. Kylie Warren, a pioneering figure in Advanced Manufacturing (AM), for an in-depth discussion on the aspects that result in business innovation within an exciting industry. Explore the nuances between quality control, assurance, and management systems, and discover their diverse applications across stakeholders within AM. Kylie shares insights into the pivotal role of technology in driving advancements, showcasing cutting-edge tools and methodologies. Breaking stereotypes in a historically male-dominated field, Kylie highlights exciting career pathways for both genders in AM. She emphasises the crucial blend of hard and soft skills, including design thinking and STEAM education, essential for success in this evolving landscape. For students, graduates, and educators alike, Kylie offers invaluable advice drawn from her experience, guiding aspiring professionals and educational institutions toward preparing for the demands of this exciting industry. Tune in for a captivating conversation filled with industry insights, career guidance, and the evolving landscape of Advanced Manufacturing.

Get ready to immerse yourself in a live, power-packed session with our panel of industry leaders from the Cleaning Prophet$ 2.0 event: Molly Marquess of Wingfoot Services, Ernesto Moreno of Moreno and Associates, Dan Schindler of Integrity Facility Solutions, Mike Sawchuck of Sawchuk Consulting, and Mark Anderson of the Profit Growth Initiative. Join us as we discover their areas of expertise, ranging from cross-selling and operations to networking and people skills, process and sales management, consulting and chemical sustainability, and quality management systems and marketing.Our conversation with the expert panel reveals fascinating insights into various aspects of the cleaning industry. Together, we navigate through the challenges of managing subcontractors, scaling businesses, and the crucial importance of having contracts in place. We discuss the essential role of quality management systems and leadership in scaling an organization. We also delve into the future of automation in the cleaning industry, exploring its potential challenges and opportunities.This is not just a conversation about business but also a lesson in resilience and determination. Listen as our experts share stories of their journey, underlining the importance of passion, networking, and staying focused. We wrap up with a celebration of the achievements of our expert panel and look forward to their continued contributions to the cleaning industry. This episode is a must-listen for anyone looking to gain valuable insights into the cleaning industry, business growth, and personal development.In this Profitable Cleaner Podcast, you will learn:The difficulty of managing subcontractors in the cleaning industry, including the importance of contracts, regulations and compliance issues. The crucial role of leadership and quality management systems in scaling a cleaning business, along with practical experiences of balancing efficiency and quality.Predictions and challenges concerning the future of automation in the cleaning industry, and how this could potentially transform mundane tasks and raise cleaning standards.Advice on increasing business value and growth through efficient operations and processes, the significance of networking, resilience, and creating a legacy.The importance of passion, learning from others in the industry, and perseverance in difficult times.We highly recommend you connect with Molly, Dan, Mark, Mike and Ernesto r here:  Connect with Molly Marquess on LinkedIn HereConnect with Ernesto Moreno on LinkedIn HereConnect with Dan Schindler on LinkedIn HereConnect with Mike Sawchuk on LinkedIn HereConnect with Mark Anderson on LinkedIn HereIf you're in commercial cleaning and want to increase your sales, become part of our community today and get the best cleaning sales content and data in the industry. Join Our Private Profitable Cleaner FB GroupFind the appropriate tools, services, and resources for your Facility Maintenance Company by exploring our sponsor companies.Usource.com Dayporter.com Cleaningprophets.comAlexmelgar.com 

Today we have a special guest joining us: Cynthia Davis, a digital nomad entrepreneur and the founder of Q3 Integrated Solutions. With over 20 years of experience in quality management systems, Cynthia helps organizations navigate the complex world of standards. In this episode, Cynthia shares her expertise on developing and enhancing quality management systems, including all the ways that it affects businesses of EVERY shape and size. She also provides valuable insights on getting your first client, leveraging your network, and the challenges of transitioning from a larger organization to running your own business. So grab your notebook and get ready to learn from Cynthia's journey and valuable advice for entrepreneurs starting or growing their businesses.ABOUT CYNTHIACynthia Davis is the founder of Q3 Integrated Solutions, a woman- and veteran-owned business. She began her career working with various management systems in the Air Force, dedicating 11 years to this service. Following that, Cynthia transitioned to the manufacturing sector in aerospace and defense for 5 years. Later, she shifted her focus to the natural gas utility industry for several years. Motivated by a desire to travel with her husband while continuing her professional pursuits, she established Q3 Integrated Solutions.Through her company, Q3 Integrated Solutions assists organizations in developing or enhancing their Quality Management Systems across various industries. They specialize in Pipeline Safety Management Systems specifically tailored for the Natural Gas Utility industry. Additionally, Q3 Integrated Solutions offers training on vital concepts within these management systems, as well as auditing and maturity level assessments to gauge the effectiveness of the programs organizations have implemented.LINKS & RESOURCESVisit the Q3 Integrated Solutions websiteFind Q3 Integrated Solutions on LinkedInConnect with Cynthia on LinkedIn

Description:In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru), and go-to-market challenges for innovative medical devices.Zach, CEO of HTD Health, is a self-taught software engineer turned serial entrepreneur. His first venture, Fresh Corner Cafe, served fresh food in Detroit's food deserts for eight years. He then founded HTD Health to craft digital health solutions, pioneering the shift to virtual care. The company supports care providers, device makers, and life sciences. Zach also founded Exos, a governance SaaS, and sold it in 2022.Weronika Michaluk, a jack-of-all-trades in biomedical engineering, business, and public health, leads HTD's Software as a Medical Device unit. With degrees from Miami and Warsaw, plus a Doctorate in Public Health, she's worked on everything from wireless ECGs to digital health consulting. At HTD, her laser focus on quality and customer satisfaction drives organizational success.Some of the highlights of this episode include:An introduction to "Compliant Agile," a balanced methodology for MedTech development that prioritizes customer interaction while maintaining regulatory compliance.The importance of choosing the right Quality Management System (QMS), highlighting the flexibility and feature-rich experience of Greenlight Guru.The need for companies to focus on their core competencies while being adaptable and compliant.The importance of a positive mindset and a well-defined success metric for any MedTech project.Quote:"Our mission is to make the industry more accessible, more human centric and more productive" - Zach MarkinReference Links:HTD Health pageHTD SaMD InsightsHTD SaMD ChassisZach Markin LinkedInWeronika Michaluk LinkedIn GG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Do you know the difference between Quality Management Systems and Continuous Improvement? This week we begin a 3 part discussion with Chad Bareither about the importance of knowing your processes and measuring the outcomes. We also discover that Chad and Fulyana have something in common – a qualification that Kim knew nothing about in over […]

Episode 009: Harsh Thakkar (@harshvthakkar) interviews Etienne Nichols (@etiennenichols), the medical device guru and community manager at Green Light Guru. Etienne shares his background in engineering, including his experience in the aerospace, steel manufacturing, and aircraft interior industries. Harsh and Etienne discuss how Quality Management Systems will evolve with technologies like artificial intelligence (AI) in the coming years. Etienne also shares his experience building a community on social media and offers insights to anyone building a community from scratch.-----Links:* MedTech Community* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.-----Show Notes(8:51) How have quality management systems changed in life sciences?(14:38)  Connectedness remains a challenge for the industry.(19:36) Tips for building a community on Linkedin.(23:25) The power of storytelling.(30:49) Two ways to build a network.-----For more, check out the podcast website - www.lifesciencespod.com

Dr. Claude Khalil An accomplished seasoned pharmacist specialised in the pharmaceutical industry, her career path is paved with sound knowledge of Pharmaceutical sciences, regulations, and quality management systems. Her passion for project management and healthcare was translated by giving back to community in Teaching and Training Pharmaceutical sciences and Project management frameworks in well-known universities. Claude graduated from Saint Joseph University Faculty of pharmacy, Beirut. She holds an MBA degree from Newport University California. She is a Project Management Professional certified from Project Management Institute  Her major strengths are in the wide and deep knowledge of current Good Manufacturing Practices, development of generics formulations, and pharmaceutical and health care regulated environment, with an important experience in Project management for the healthcare sector. In addition, she is accredited for Organizational transformation and Quality Management Systems. She is a speaker at various national and international conferences related to Healthcare and Project management. You can connect with Claude on LinkedIn and Twitter   If you enjoyed this episode, please hit subscribe so you get all the recent conversations with professionals from around the world working with Quality.

In this podcast, we interviewed Katie Keller, Director of Quality and Safety at Asahi Kasei Bioprocess America, about the importance of quality management and how to achieve the best possible results. Topics included the most critical elements of quality management, how to ensure the purchase of high-quality equipment, and future trends. I started the conversation by asking Katie what she thought were the most critical elements of quality management. Katie replied by saying that a holistic approach to quality is best for any organization. It used to be that the quality unit was considered responsible for product quality, making all the decisions, and driving all the improvements and that's not really the case today. She feels the most successful approach is that since quality is so important, everyone should be responsible for it. She went on to say that when all employees understand how they contribute to product and service quality and therefore customer satisfaction, there is more buy in throughout the organization. People are empowered to take responsibility for the improvement of the processes they manage, and this total quality management is achieved by clearly defining the interaction of each process to another, ensuring employees understand that, and then setting the expectation that quality is achieved from every level of the organization with everyone playing a part. I then asked Katie what should bioprocess equipment customers be looking for to ensure that they are purchasing high quality equipment? She told me that across industries, it's common for customers to search for suppliers with robust quality management systems. As a supplier, Asahi Kasei Bioprocess America (AKBA) can minimally prove this by achieving and advertising certification to ISO 9001. This shows that Asahi Kasei meets the minimum expectations for a manufacturing company to provide those quality products and services, but it really doesn't stop there. If they can show their customers that they have well designed, thorough processes that are continually improving, this naturally leads to better quality products and customers gain confidence in their ability to meet ongoing needs. I continued the discussion by asking if she could talk a bit about ISO certification and why it's an important part of their quality management system. Katie explained that ISO 9001 really is the minimum. Their customers in the pharmaceutical industry might stop and look when they see the ISO certification, but what really brings them confidence and satisfaction are the ways Asahi Kasei goes above and beyond this. For AKBA, ISO certification is not just words on a page, there is a reason why every requirement in that standard exists. Katie shared that she believes it is her job to interpret this in a way that means something to her organization, so they can not only live it but improve upon it and take the next step. She elaborated on her point by saying that it is how you build upon those minimum criteria that truly shows a customer who you are and what is important to you as an organization. This is how a company can start to build that quality culture where the employees believe in the message that customer satisfaction, both internal and external, comes first. I asked her about how these quality management systems affect the design and build of their equipment and how they have an impact beyond the quality management systems. Katie said that having ISO as a guideline is helpful for this, especially if they need to create or revamp a process. Asahi Kasei Bioprocess starts by asking what ISO requires to get a baseline and then looks at what their customers' expectations for safety, quality, and productivity are. She explained that by keeping both these things in mind, they can create robust processes with controls or checkpoints to ensure they are satisfying all the requirements. However, that example is at the front end of creating a new process,

Regenerative Medicine Today welcomes Mr. Shawn Bengtson.  Mr. Bengtson is the Quality Systems Manager at the McGowan Institute, implementing a Quality Systems Program supporting the Center's Preclinical Studies. Mr. Bengtson discusses his work in Quality Management Systems and how it differs from Good Lab Practices. For more information about Mr. Bengtson, click here. [...]

In this episode of the series, Matthew and Cindy provide a 10 minute guide to BS 99001 - Quality Management Systems – specific requirements for the built environment.Series | Standards in 10 MinutesGet in touch@StandardsShow@thestandardsshoweducation@bsigroup.com

Our host, David Crysler, breaks down 10 simple steps to create or improve a Quality Management System that will lower the cost of quality in your manufacturing operation.

In this podcast, we interviewed Katie Keller, Director of Quality and Safety at Asahi Kasei Bioprocess America, about the importance of quality management and how to achieve the best possible results. Topics included the most critical elements of quality management, how to ensure the purchase of high-quality equipment, and future trends. I started the conversation by asking Katie what she thought were the most critical elements of quality management. Katie replied by saying that a holistic approach to quality is best for any organization. It used to be that the quality unit was considered responsible for product quality, making all the decisions, and driving all the improvements and that's not really the case today. She feels the most successful approach is that since quality is so important, everyone should be responsible for it. She went on to say that when all employees understand how they contribute to product and service quality and therefore customer satisfaction, there is more buy in throughout the organization. People are empowered to take responsibility for the improvement of the processes they manage, and this total quality management is achieved by clearly defining the interaction of each process to another, ensuring employees understand that, and then setting the expectation that quality is achieved from every level of the organization with everyone playing a part. I then asked Katie what should bioprocess equipment customers be looking for to ensure that they are purchasing high quality equipment? She told me that across industries, it's common for customers to search for suppliers with robust quality management systems. As a supplier, Asahi Kasei Bioprocess America (AKBA) can minimally prove this by achieving and advertising certification to ISO 9001. This shows that Asahi Kasei meets the minimum expectations for a manufacturing company to provide those quality products and services, but it really doesn't stop there. If they can show their customers that they have well designed, thorough processes that are continually improving, this naturally leads to better quality products and customers gain confidence in their ability to meet ongoing needs. I continued the discussion by asking if she could talk a bit about ISO certification and why it's an important part of their quality management system. Katie explained that ISO 9001 really is the minimum. Their customers in the pharmaceutical industry might stop and look when they see the ISO certification, but what really brings them confidence and satisfaction are the ways Asahi Kasei goes above and beyond this. For AKBA, ISO certification is not just words on a page, there is a reason why every requirement in that standard exists. Katie shared that she believes it is her job to interpret this in a way that means something to her organization, so they can not only live it but improve upon it and take the next step. She elaborated on her point by saying that it is how you build upon those minimum criteria that truly shows a customer who you are and what is important to you as an organization. This is how a company can start to build that quality culture where the employees believe in the message that customer satisfaction, both internal and external, comes first. I asked her about how these quality management systems affect the design and build of their equipment and how they have an impact beyond the quality management systems. Katie said that having ISO as a guideline is helpful for this, especially if they need to create or revamp a process. Asahi Kasei Bioprocess starts by asking what ISO requires to get a baseline and then looks at what their customers' expectations for safety, quality, and productivity are. She explained that by keeping both these things in mind, they can create robust processes with controls or checkpoints to ensure they are satisfying all the requirements. However, that example is at the front end of creating a new process,

What's the best way to develop world-class Quality Assurance (QA)  professionals in the clinical trials industry? That's one of the key questions explored during Linda Sullivan's interview with David Fryrear, Executive Vice President and Head of Quality Assurance at Astellas Pharma, Inc. Clinical QA was first defined as “auditing,” says Fryrear, but it has morphed into a critical element in Quality Management Systems and is continuing to transform itself today. In addition, Fryrear notes, QA is now a resource for business partners and is a key contributor and independent voice in critical decision-making in the clinical trials process. Today, Fryrear says, top-notch QA professionals must demonstrate an ability to go beyond simply being well versed in regulatory and compliance issues, but must have different competencies, including an understanding of risk management, the ability to interpret data and apply critical thinking to solve problems as well as communicate effectively with peers and business partners. Fryrear notes that Astellas has mapped out the core competencies needed and provides employees with opportunities to work closely with experienced staff to learn about and broaden their knowledge and expertise. “Quality is not the responsibility of QA – it is something that everyone needs to get involved in,” says Sullivan. Want to suggest a topic for CTO? Just email Linda Sullivan at lsullivan@wcgclinical.com

This week's guest is Dereck Williams. Ron and Dereck discussed Quality Management Systems, what they entail, and how to ensure your efforts are successful and sustainable. An MP3 audio version of this episode is available for download here. In this episode you'll learn:  The quote Dereck likes (1:26) His background and what he's up to these days (2:31) About Quality Management Systems (5:30) The role lean plays in a QMS (7:04) Ensuring QMS doesn't become superficial (10:32) Some of the challenges that come with the certifications (14:08) The companies who don't get it (18:57) The difference in approach depending on the size of your company (20:34) Advice on getting started (22:22) Podcast Resources Right Click to Download this Podcast as an MP3  AME Conference - Use Promo Code Gemba15 for 15% off Gamma Group What Do You Think? What has your experience been with Quality Management Systems?

In this first episode of a new series, Matthew provides a 10 minute guide to ISO 9001 – Quality Management Systems.Series | Standards in 10 Minutes@StandardsShow@thestandardsshoweducation@bsigroup.com

In this episode of the Translation Company Talk we sit down with Leigh Turgut, Quality & Compliance Manager from CQ fluency and she talks to us about the principles and benefits of a Quality Management System, the different definitions of Quality within a language translation company. Quality is something we all promise our clients and clients naturally assume every vendor delivers translation with optimum quality, but how do we measure quality? Like in any industry quality issues can arise, particularly with the something as subjective as language. Leigh is a veteran industry expert,having occupied multiple roles within localization, she eventually found her niche in Quality & Compliance, and now oversees and aims to grow that function at CQ fluency. In this interview we cover many topics, including the definition of quality in product, process and perception by client in addition to many other interesting topics. Don't forget to subscribe to the Translation Company Talk podcast on Apple Podcasts, iTunes, Google Podcasts, Spotify or your favorite platform. Give this podcast a thumbs up wherever you are listening, and send us your comments and feedback. The Translation Company Talk podcast is sponsored by Hybrid Lynx.

Donor and product safety has improved significantly over the last decade as a consequence of the introduction of measures such as evidence-based blood donor selection criteria. In parallel, the implementation of quality assurance programs based on good manufacturing practices has also played a key role in improving the safety and quality of blood and blood components. The main objective of a quality program within the blood bank and transfusion service is to minimize risk to safety and quality by ensuring that the lab's processes will reliably deliver safe blood and blood components. In many countries, implementation of a quality certificate program has become a regulatory or government requirement; however, an effective program not only forms the basis for safety but can also deliver benefits to the Blood Service beyond meeting compliance. Learn in this episode from AABB consulting services how commitment to safety and quality is available with the new AABB Quality Certificate Program – Based on AABB's Fundamental Standards for Blood Collection and Transfusion, the Certificate is an internationally recognized distinction, acknowledging your facility's commitment to a culture of quality and excellence.  About our Speaker: Christine Bales is the AABB Vice President of the Consulting and Global Services and serves as a technical expert in Quality Management Systems for Blood Centers and Transfusion Services. Christine designs implementation models to be used as roadmaps for Blood Donor Centers and Transfusion Services' facility accreditation processes and quality system improvements. She has experience as an assessor for AABB and a CAP inspector. Christine has over 20 years of management experience in clinical laboratories, blood donor centers, and hospital-based transfusion services. During Christine's years as CEO and senior management, she led organizations through strategic planning, process improvement activities, and facility accreditation processes. Christine holds a Certificate in Organizational Leadership from Harvard University, a Bachelor of Science in Biology from Purdue University, and certifications in Medical Technology and Immunology from ASCP. She is a member of the AABB (Association for the Advancement of Blood and Biotherapies) ASCP (American Society of Clinical Pathology), ASQ (American Society for Quality), and CLSI (Clinical Laboratory Standards Institute).

In this podcast episode we chat with Greg Casey from Interxion about the most important trends for Irish data centres to watch in the near future, and some insights into how to effectively communicate what your business does well. Greg Casey Greg has over 35 years of experience in the IT/Software sector and brings over 35 years of experience working with global organisations, managing strategic technical projects and teams across global networks, Construction, Electrical & Mechanical Services, Safety and Quality Management Systems among other areas. Greg lives in Glasnevin, Dublin with his wife and one of his daughters, while his other daughter lives in Vancouver. Greg's hobbies include golf, cycling and aviation. Company Overview About Interxion, A Digital Realty Company Interxion, A Digital Realty Company, supports the world's leading enterprises and service providers by delivering the full spectrum of data centre, colocation and interconnection solutions. PlatformDIGITAL®, the company's global data center platform, provides customers a trusted foundation and proven Pervasive Datacenter Architecture (PDx™) solution methodology for scaling digital business and efficiently managing data gravity challenges. Digital Realty's global data center footprint gives customers access to the connected communities that matter to them with 290 facilities in 47 metros across 24 countries on six continents. To learn more about Digital Realty, please visit digitalrealty.com or follow us on LinkedIn and Twitter.

In this episode of SkillFront Magazine, we talked to SkillFront’s Yeliz Obergfell, Vice President – Professional Services, about SkillFront, the premier skill development and official credentialing organization, compliant with ISO/IEC 17021:2015 and ISO/IEC 17024:2012 standards for certification bodies. Our interesting subject for today is SkillFront ISO Certifications For Businesses. Why Should Companies Get SkillFront ISO 9001 Company Certification? The SkillFront Certified Professional Certification programs' chief goal is to be market relevant, consensus-based, support innovation, and provide solutions to global challenges. That means thriving career chances for professionals, and meeting and exceeding demands from businesses and their valuable clients. Having formal ISO quality management systems in place is vital to getting clients to sign up for offers, and that's why having an ISO 9001 company certification is so important. If you're wondering about the easiest and fastest way to get an ISO 9001 company certification, you're in the right place. In this episode today, we tell you all about our offer of an online ISO 9001:2015 Quality Management Systems Certified Business Certification. It's a perfect way to ensure that you have ISO 9001 quality management systems in place. It will also help you prove compliance with these globally-recognized and continuously improving standards, thanks to the ISO certification for your company. Utilizing our fast and easy system for ISO 9001 company certification is a no brainer, and in this video, we'll go over all the reasons why you should do it today! SkillFront represents Swiss Quality From ISO’s Home: ISO 9001 Company Certification, Affordable, Fast Track and Online. Let us Help you Get Your Business Certification For ISO 9001:2015 Quality Management Systems, Affordable, Fast Track and 100% Online All-Inclusive Package! SkillFront ISO Certifications For Businesses How Much Does ISO 9001 Certification Cost? SkillFront offers One Small Discounted Price. The ISO 9001 Certification Bundle includes everything you and your company need to succeed. The ISO 9001 Certification Bundle includes: ISO 9001:2015 Quality Management Systems Certified Business Certification (With an Online Verifiable Barcode on it)BONUS #1. Sharable and Verifiable Digital Badge (Your Company Name Engraved On It, Custom Made For You)BONUS #2. ISO 9001:2015 Quality Manual: 45+ Pages The one-time discounted registration fee for this entire ISO 9001 Certification is only USD 497. There are no other fees ever after your registration. SkillFront ISO 9001 Certification Cost What are the requirements for ISO 9001 Certification? SkillFront offers its worldwide renowned and recognized services with 100% Money-Back Guarantee. Are you afraid of failing in your registration for the ISO 9001 Company Certification? You no longer need to be because we are going to do all of the legwork for you. We take all risks on our shoulders, so you can focus on doing what you do best, which is serving your clients at your highest levels possible and positively influence their outcomes that would not happen otherwise. All legitimate businesses that serve the professional and public interest in good faith are eligible to comply with ISO 9001:2015 Quality Management Systems Certified Business standards. Nevertheless, at the end of our validation process for your company, if our team will conclude that we will be unable to certify your business and its practices in ISO 9001:2015 standards, we will hassle free refund your full registration fee without asking any questions. What are the benefits of ISO 9001:2015 Certification? ISO 9001 are the standards that set out the requirements for quality management systems. It helps businesses and organizations to be more efficient and improve customer satisfaction. Implementing ISO 9001 quality management systems will help you: Assess the overall context of your organization to define who is affected by your work and what they expect from you. This will enable you to clearly state your objectives and identify new business opportunities.Put your customers first, making sure you consistently meet their needs and enhance their satisfaction. This can lead to repeat customers, new clients and increased business for your organization.Work in a more efficient way as all your processes will be aligned and understood by everyone in the business or organization. This increases productivity and efficiency, bringing internal costs down.Meet the necessary statutory and regulatory requirements.Expand into new markets, as some sectors and clients require ISO 9001 before doing business.Identify and address the risks associated with your organization.Compliant with the standards of ISO/IEC 17024:2012 Conformity: General requirements for bodies operating certification of companies and professionals, ISO/IEC 17021:2015 Conformity: Requirements for bodies providing audit and certification of management systems. SkillFront ISO 9001 Certification How Can Companies Register and Get Started With SkillFront ISO 9001 Certification? I am sure that you must be very busy serving your customers and business stakeholders at your highest levels possible, so I don’t want to take up too much of your time. Today I would like to give you a brief outline of all our ISO company certification programs. You can browse our limited-time reduced plans and more info about these programs from their respective links below, so you can see and decide if these programs work for your organization: ISO 9001:2015 Quality Management Systems Certified BusinessISO/IEC 27001:2013 Information Security Management Systems Certified BusinessISO 14001:2015 Environmental Management Systems Certified BusinessISO/IEC 20000:2018 Information Technology Service Management Systems Certified BusinessISO 22301:2019 Business Continuity Management Systems Certified BusinessISO 50001:2018 Energy Management Systems Certified BusinessISO 45001:2018 Occupational Health And Safety Management Systems Certified BusinessISO 14298:2013 Graphic Technology – Management Of Security Printing Processes Certified Business SkillFront’s Website and How People Can Contact SkillFront? SkillFront Official HomapageSkillFront on LinkedInSkillFront on TwitterSkillFront on FacebookSkillFront on CrunchbaseSkillFront on InstagramSkillFront on Apple PodcastsSkillFront on RedditSkillFront on SpotifySkillFront on IssuuSkillFront on PinterestSkillFront on BehanceSkillFront on AmazonSkillFront on F6SSkillFront on Trending GeniusSkillFront on Startup InfoSkillFront on MediumSkillFront on DribbleSkillFront on Education AdviceSkillFront on AngelSkillFront on StitcherSkillFront on Player FMSkillFront on Product HuntSkillFront on YouTubeSkillFront on VimeoSkillFront on InfogramSkillFront on Legit Open CorporatesSkillFront Podcast HomeSkillFront Google PodcastSkillFront Tune In PodcastSkillFront Castbox Podcast Final Notes and Verdict About SkillFront, The Competence Platform For Professionals and Businesses In summary, SkillFront is a great company to work with and collaborate. SkillFront Accreditation: SkillFront Is The Premier Skill Development and Official Credentialing Organization, Compliant With ISO/IEC 17024:2012 Standards For Certification Bodies. SkillFront is proud to be compliant with the standards of ISO/IEC 17024:2012 Conformity: General requirements for bodies operating certification of companies and professionals, ISO/IEC 17021:2015 Conformity: Requirements for bodies providing audit and certification of management systems, and ISO 9001:2015 Conformity: Requirements for quality management systems. SkillFront is a private LLC registered in Switzerland. They build their services, and they serve you and your business from Switzerland with love. SkillFront is the leading organizational and professional competence development and certification body that provides education and certification services globally in all domains of business and information technologies. SkillFront Address and Location: Samstagernstrasse 57 8832 Wollerau Switzerland SkillFront CEO: Yeliz Obergfell (Yeliz Obergfell on LinkedIn) SkillFront Other Key Executives: Erkan Sutculer (Erkan Sutculer on LinkedIn), Eric Lefebvre (Eric Lefebvre on LinkedIn) SkillFront Reviews From Satistified Professionals and Enterprises: https://www.facebook.com/skillfront/reviews See you next time!

We talk with Tom Gorman to learn more about trends in collocation and sustainability initiatives taking place in Ireland Tom joined Interxion with over 29 years of experience working with global organisations, managing strategic technical projects and teams across global networks, Construction, Electrical & Mechanical Services, Safety and Quality Management Systems among other areas. More recently, Tom has spent the past 5 years working in Senior Operational roles within AWS Data Services, both in Ireland and Germany where he was responsible for developing & mentoring an Agile World Class Operations team tasked with delivering Operational Excellence across multiple regions. Interxion, A Digital Realty Company Interxion, A Digital Realty Company, supports the world's leading enterprises and service providers by delivering the full spectrum of data centre, colocation and interconnection solutions. PlatformDIGITAL®, the company's global data center platform, provides customers a trusted foundation and proven Pervasive Datacenter Architecture (PDx™) solution methodology for scaling digital business and efficiently managing data gravity challenges. Digital Realty's global data center footprint gives customers access to the connected communities that matter to them with 290 facilities in 47 metros across 24 countries on six continents. To learn more about Digital Realty, please visit digitalrealty.com or follow us on LinkedIn and Twitter.

We preach each week about how Quality Matters and what benefits we have when it goes well. But this time, we are starting a mini series on what can go wrong, and horribly horrible wrong when Quality Management Systems fail. The first in this week's mini series, we explore what went wrong with the Three Mile Island nuclear plant disaster. This is the initial article with the top 5 disasters. https://www.qad.com/blog/2019/09/the-top-five-quality-management-system-failures-of-all-time This is the article on 3 mileisland I found and referenced https://world-nuclear.org/information-library/safety-and-security/safety-of-plants/three-mile-island-accident.aspx Learn more about #QualityMatters & Texas Quality Assurance :LinkedIn | Facebook | Twitter  | Instagram  | YouTubewww.qmcast.com | Texas Quality Assurance

Dave revisits his conversation from season 1 with Eric Sanders of the Schaller Group. Dave adds some context and highlights his favorite takeaway's from each of the 3 key segments from this episode.

‘A modern beer from an ancient land.’ Christina, Thandi, and Katie talk with Aine who leads Connemara Brewing, one of the very newest wonders of the Wild Atlantic Way in the West of Ireland.How did Aine O’Hora become a technical brewer of broad range and ability, and a maven of swabbing and quality control? With a biotechnology degree in DCU here, and a year’s work experience in Harp there. A bit of work in the pharmaceutical industry. A Masters at Herriot Watt in Scotland. Off to Australia’s Matilda Bay, working in wellies and learning her trade. From there to VB, processing 1100 hectolitre batches of ‘Victoria Bitter’ lager every 2.6 hours. Back to Ireland again, helping to set up craft brewers Wicklow Wolf. Finally arriving home again, and now making lager and ale by hand in an old-fashioned, open fermentation, ten hectolitre brewhouse. That’s how!We wish the new project plenty more manual brewing and Quality Management Systems certificates in the years to come. Thanks to Aine and Connemara Brewing for the interview, and for bringing incredible local lager to the beauty spots of Ireland.Beers:Connemara, Galway - Lager  - https://www.connemarabrewery.comConnemara, Galway - Ale  - https://www.connemarabrewery.comFour Provinces, Dublin - ‘Hurler’ Copper Ale - https://www.fourprovinces.ieWestern Herd, Clare - ‘Coast Road’ IPA - https://www.westernherd.com/product/coast-road/Links:Connemara Brewing Co. - https://www.connemarabrewery.comHerriot Watt, UK - https://www.hw.ac.uk/Matilda Bay, Australia - https://matildabay.com/Follow the Beer Ladies here:YouTube - Beer Ladies PodcastInstagram - https://www.instagram.com/beerladiespodcast/Twitter - beerladiespodFacebook Page - Beer Ladies PodcastWebsite - http://beerladiespodcast.com/Please like, rate, share, and subscribe - you know the drill ;)Cheers!

Karen Newton is the founder and director of The £2.73 Club. She is naturally evolved, of finance first, leaving school, working for Inland Revenue in the UK, then moving to New Zealand. She went into Banking before setting up her businesses and finally founding the £2.73 Club. She moved from New Zealand to Australia, but it was short-lived. She started writing books about property investing in 2003. Her books sell worldwide in the markets being America, Canada, Australia, and New Zealand. In 2014 She was awarded 'Entrepreneur of the Year' from America for my books. Today, she has property investments in UK, France, and Spain. A Share Investment Portfolio. Books that sell worldwide and an array of different businesses. In this capacity, she provides not only funding but training on Business Planning and Quality Management Systems. More Information visithttp://karennewton.co.ukwww.youtube.com/newydd105https://2pound73club.co.uk Hosted on Acast. See acast.com/privacy for more information.

What We Covered00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today's topic: Quality Management Systems (QMS) Explained!  07:53 – The panel expounds on the timing necessary for QMS and what role the quality manual plays  13:06 – The panel explains the Code of Federal Regulations (CFRs)  17:30 – The panel defines Phase Appropriate as it pertains to QMS23:12 – Identifying which guiding documents to follow  27:29 – The value in having an experience quality professional  31:54 – Why a quality agreement is necessary  35:32 – The panel provides final words of wisdom on Quality Systems Management  Tweetable Quotes“Quality System Management provides an infrastructure for a company to ensure the quality of your drug product with patient safety in mind as its primary function.” “It helps determine and define management's commitment to quality. Because if you don't have senior management commitment, all could be lost.”“To begin at the beginning, when you set up your QMS, you need to start with the procedures and processes that will reduce risk and help you prepare for your submission in the long run. That would come through managing your documents.” “Guidance documents are just an opinion. And they actually say that in the documents. So, you kinda try to do a combination of everything.”“The biggest thing is that when you have somebody who's experienced and they've been through various things like FDA audits or have worked with a very small company versus a very large company, they can differentiate what you really need right now.” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInBettina Kaplan on LinkedInSusan Fasso on LinkedInRobbi Freisem on LinkedInMaria Arakil on LinkedIn

This is the introduction chapter for ISO 9001:2015 which will bring the basics of QMS implementation in any organization.We talk about the benefits and principals of QMS and the most important aspect on PDCA cycle and Risk based thinking.

Our topic of conversation today is Quality Management Systems in the Oil and Gas Horizontal Drilling industry. A Quality Management System is a framework that optimizes internal processes and policies for the continuous improvement of quality. The approach builds on clear documentation of roles and responsibilities, procedures for each function, then continuously evaluates those processes for quality. Quality management is not just about eliminating errors or prevent them from recurring. It's also about corporate culture. Ignoring small issues increases risk. And accepting failures inhibits an organization from pushing quality requirements out to vendors and other suppliers. Deep Well Services is one of the few companies in this industry that has earned the American Petroleum Institute (API) Q2 and the International Standards Organization (ISO) quality management system accreditation. For more information go to EngageEIC.com

Dave talks with Eric Sanders of the Schaller Group to get his perspective on how culture plays a role in the success of these and how you can use them within your company to improve.

This is a presentation of the California Colleges Contract Education Summit 2020.Jorge Zegarra, from the College of the Sequoias Training Resource Center, talks about the "Pitfalls and Challenges of Managing Contract Education."Jorge is a bilingual Quality Management Systems and Continuous Improvement professional with over 30 years of extensive international experience in the manufacturing and service industries in the USA, Latin America and Asia. Functioned in various production, quality assurance and management capacities. Jorge is a Certified ISO 9001 Lead Auditor and Lean & Six-Sigma practitioner. He is also an Adjunct Lecturer with the Department of Industrial Technology at Fresno State University. Currently Jorge is the Director of College of the Sequoias Training Resource Center, which provides customized training and consulting services to private and public organizations in the California Central Valley as part of regional economic and workforce development. Jorge has earned his M.B.A. from California State University Fresno, his B.S. Engineering Technology from California State University Long Beach and his CTE degree in Machine Tool Technology from SENATI Industrial Institute.

Key takeaways:Learn about DISRUPTIVE technologies shaping the future of MedtechWhy AI won't take the role of doctorsTools for success from someone with GLOBAL leadership experienceHow working in the medical device industry affects how you see things as a PATIENTAbout Matthias: Mr. Buerger is the Vice President Regulatory Affairs and Quality Assurance EMEA for Zimmer Biomet.  He has a Master's of Science degree in Biomedical Engineering from Marquette University in Milwaukee, WI, as well as a Dipl. Ing. degree in Electrical Engineering from Fachhochschule Dieburg in Germany. In the past Mr. Buerger has had a variety of different management roles in Quality Assurance and Regulatory Affairs for companies including GE, Baxter, Terumo & Guidant. He has also worked as a Quality Management Systems and Operational consultant for Grant-Thornton, as well as spending time as a lead auditor and test engineer for TUV Rheinland, a European Notified Body. Mr. Buerger has spoken at a variety of international conferences, including RAPS, MD&D, ASQ, IEEE and others.  Career inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

ISO 9001:2015 PDF checklist DOWNLOAD below! ISO 9001 online training course presented by CEO Kobi Simmat. An advanced, step-by-step breakdown of our ISO 9001:2015 PDF checklist. Go and dive into our amazing ISO 9001:2015 Gap Analysis Checklist Course that we have available as the perfect introduction and implementation tool to accompany your management system https://bit.ly/2SGswGm Follow and subscribe to: Best Practice Website : https://goo.gl/uJTioQ Facebook : https://goo.gl/VOJfKZ LinkedIn : https://goo.gl/dZmlTr Youtube : https://goo.gl/8SVD9E Instagram : @bestpracticetv Snapchat : @bestpracticetv Dreams by Joakim Karud https://soundcloud.com/joakimkarud Creative Commons - Attribution-ShareAlike 3.0 Unported- CC BY-SA 3.0 http://creativecommons.org/licenses/b... Music provided by Audio Library https://youtu.be/VF9_dCo6JT4

We spent some time with Kyle Chambers and Chad Henry of Texas Quality Assurance talking about quality management systems and how you can eliminate a vast majority of the paperwork associated to HSE in your business. Learn how software can help streamline your processes, reduce the amount of time your employees spend waiting on documentation associated with their work, and keep your people safe by keeping them informed. If you have a quality management system in place and need help getting ready for an upcoming audit, or you have a mountain of paperwork but don’t have the first clue about where to start digitizing it all, give Kyle and the guys over at Texas Quality Assurance a call. Without a doubt these guys can help you get sorted out and improve you operations along the way. Click Play to Hear #018 Oil And Gas HSE Podcast: Quality Management Systems and Eliminating Endless Paperwork We Have A Winner!!! Congratulations Carl Turner, State Fire Marshall for the State of Texas, you are this week’s winner of the Red Wing Offshore Bag! If you want to win one of these awesome Rig Bags, all you have to do is enter! Click Here to Enter [clear-line] More Information For more information about everything related to quality management systems, reach out to the guys at Texas Quality Management. If you’re not sure how they can help you, at least take a look at their free resources by clicking here. And if you’re still using Excel for everything you do, make sure you ask Kyle how SharePoint can streamline your processes and take a look at the training they offer by clicking here. If you would like to connect with Kyle, you can find him on LinkedIn. If you would like to connect with Chad, you can find him on LinkedIn. [clear-line] This Is Your Show! Tell Mark and Patrick what topics you would like to hear discussed on the show! Click Here to Email Us [clear-line] Global Oil And Gas Network LinkedIn Group Join the number one SPAM FREE LinkedIn group for people interested in the oil and gas industry! Click Here to Join [clear-line] Get Mark & Patrick’s Monthly Events Emails Get automatically notified about oilfield and process improvements events every month. Get Mark’s Oil and Gas Events Newsletter Get Patrick’s Process Improvement Events Newsletter [clear-line] Connect With Us Patrick Pistor | Twitter | LinkedIn | Email |Facebook |

Sponsored By In a recent interview with Quality magazine, Paul Keller, president of Quality America and author of McGraw-Hill's newly released SPC Demystified, shared insight into why SPC is crucial for quality management systems. 

Quality Management Systems in cannabis with Andrew Samann, Founder and CEO of Orion GMP Solutions. Orion is a pharmaceutical process engineering firm focusing on the implementation and auditing of internationally harmonized Good Manufacturing Practices and Quality Management Systems in the pharmaceutical, dietary supplement, cosmetic, and cannabis industries. Andrew serves on the Executive Committee of the ASTM International D37 Cannabis Standards Committee, where he is the chairman of the Quality Management Systems Committee.