Podcasts about Quality assurance

In this episode we spoke with Damien Wong, Senior Vice President for Asia Pacific at Tricentis, about how Agentic AI is redefining software quality assurance (QA) for enterprises navigating digital transformation. Damien shared his journey through 30 years in enterprise technology and explained how Tricentis is pioneering a future where autonomous testing drives both speed and reliability in software delivery. We explored why QA is fast becoming a board-level priority, how AI is removing the human bottlenecks in testing, and why quality is now existential in sectors like finance, healthcare, and government. Key Insights: • From manual to agentic: QA has evolved from manual testing to script-based automation, to codeless model-based testing, and now to agentic test automation. The equivalent of moving from driving a car to a fully autonomous vehicle. • AI-accelerated quality: Tricentis' agentic automation enables systems to autonomously create, execute, and adapt tests, dramatically accelerating release cycles and reducing risk from untested code. • Quality as a board concern: In Tricentis' Quality Transformation Report, two-thirds of organizations admitted to shipping untested code, making QA failures a C-suite and reputational risk rather than an IT issue. • Compliance through transparency: With acquisitions like SeaLights, Tricentis helps enterprises prove that every code change has been tested—critical for regulated sectors and global compliance. • Bring-your-own-AI flexibility: Tricentis' support for the Model Context Protocol (MCP) allows companies to plug in their own private AI models, ensuring data security and regulatory control while leveraging AI capabilities. • Empowering, not replacing, engineers: AI-driven testing shifts QA teams from repetitive test creation to strategic oversight, while tools like NeoLoad with natural language prompts make performance testing accessible to non-technical users. • Industry impact: From Zespri's self-healing ERP testing to preventing outages like Haribo's global gummy bear disruption, intelligent QA ensures business continuity and customer trust. • Future outlook: With 90% of code expected to be AI-generated within a year, the ability to test at AI speed will define competitive advantage in enterprise software delivery. IoT ONE case study database: https://www.iotone.com/case-studies The Industrial IoT Spotlight podcast is produced by Asia Growth Partners (AGP): https://asiagrowthpartners.com

In this special in person episode of The Behavioral View, hosts Dr. Shannon Hill and Dr. Nissa Van Etten broadcast from the CR Unite 2025 Conference in Chicago to discuss the latest innovations shaping behavior analysis. They're joined by Amber Ledesma, BCBA and Customer Success Lead III at CentralReach, and Dr. Alana Fallucca, Director of Quality Assurance at Above and Beyond Therapy, for an unscripted, in-person conversation about the evolution of assessments, outcomes tracking, and AI in clinical practice.  While there is no CEU associated with this episode at this time if you wish to watch the episode and earn 30 minutes Staff Training certificate.  Please click here.

Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength. You'll learn: What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE) How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA) How EU MDR uses RWE through PMCF and PMS The key differences in approach between the two regions A practical 5-step roadmap to build a compliant RWE strategy Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them

Send us a textToday we're discussing a topic that's bringing well-deserved recognition—and financial support—to the educators who are the backbone of our child care system: the Quality Rated Workforce Bonuses. Funded by DECAL, this annual $500 bonus is a way to say “thank you” to the teachers and staff who go above and beyond in serving children and families. Joining us with an update on the Quality Rated Workforce Bonuses is Rachel Lee, Assistant Director of Quality Assurance and Business Operations for Quality Innovations and Partnerships. Support the show

On this episode of Beyond the Horizon, we sit down with Senior Master Sgt. Derek Sams, the installation superintendent of the 220th Engineering Installation Squadron, and Tech. Sgt Zachary grant, the Quality Assurance representative for the 220th EIS, to discuss why it's important to strive to meet you full potential as one of the Ohio Adjutant General's 19 Fundamentals for the Soldiers and Airmen of the Ohio National Guard.You can connect with us on: Facebook: http://www.facebook.com/178WingInstagram: http://instagram.com/178th_wingYou can write to us at: beyondthehorizonpodcast@gmail.com

In this episode, Shiv is in conversation with Naresh Choudhary, Senior Vice President, Quality & Productivity, Infosys Ltd.Naresh shares his career journey starting from humble beginnings in Mumbai, studying engineering at VJTI, working at Arvind Mills, and eventually contributing to Infosys for 25 years. The discussion covers his transition from manufacturing to IT, the influence of mentors, various roles at Infosys, and the importance of reframing roles. Naresh also emphasizes the value of great work, networking, mentorship, and maintaining a work-life balance. He talks about driving innovation and change management effectively within a large organization through transparent communication, planning, and continuous feedback. Finally, Naresh offers personal practices like journaling, exercising, and separating work from family time to stay grounded and calm.00:00 Welcome and Introduction00:23 Early Career and Education02:00 Transition to Infosys03:43 Roles and Responsibilities at Infosys07:16 Mentorship and Career Growth10:28 Defining Great Work15:32 Overcoming Self-Doubt and Imposter Syndrome19:28 The Importance of Mentors24:23 Networking and Time Management29:19 Clearing the Mind for Focus29:51 Work-Life Balance and Breaks30:59 Organizational Change and Trust33:51 Planning and Transparency in Change34:51 Process Over Tools36:04 Sponsorship and Milestone Reviews37:46 Encouraging Knowledge Sharing43:58 Innovation and Idea Management47:33 Staying Grounded Amidst Responsibilities53:00 Personal Practices for Balance56:48 Conclusion and Final ThoughtsBio:In his stint at Infosys over 2 decades, Naresh has worked in different roles in Software Delivery, Consulting, Quality Assurance, Open Source, Enterprise Platforms, Products, Tools & Technology that have provided him opportunities to work on key transformation programs.Naresh has experience in Software Development, Quality System Design, Process definition, Implementation and Consulting, Product & Platform Engineering, Software Reuse, Knowledge Management, Training, Audits and Assessments. He possesses a sound understanding of various quality models, methodologies and frameworks like CMMI, ISO, Six Sigma, MBNQA, AI, Automation,  Agile, DevSecOps & SRE.Naresh participates on several product councils and advisory boards with Infosys' global technology partners and is currently leading the effort on reimagining the tooling, engineering excellence, digital platforms, Lean and automation landscape for the enterpriseHe is a self confessed Foodie, History enthusiast, Amateur Chef, Motivational Speakerhttps://www.linkedin.com/in/nareshchoudhary/

Kieron Allen speaks with Chris Pope, Chief Product Officer at AutomatePro, in an in-depth discussion that is part of a broader series of podcasts, articles, and reports on ServiceNow's evolving ecosystem. They explore how intelligent automation and agentic AI are reshaping DevOps and quality assurance. The conversation also highlights how AutomatePro's built-on approach enhances developer productivity, reduces risk, and ensures security, all within the ServiceNow environment.AutomatePro's AI EdgeThe Big ThemesAutomatePro's Core Mission: AutomatePro focuses on solving one of the most time-consuming parts of software delivery: testing and documentation. Pope explains that their goal isn't to replace humans but to augment their efforts through intelligent automation. By embedding deeply within the ServiceNow platform, AutomatePro allows developers and platform owners to automate repetitive tasks early in the development cycle, ensuring higher-quality releases and faster deployment.Human-AI Collaboration Wins: The myth of AI replacing people is outdated. Pope reframes the conversation: it's not about replacement, it's about enablement. The real winners will be those who know how to use AI effectively. Today's Copilots are context-aware, learning from human behavior and adapting to different personas — whether it's a developer, analyst, or HR owner. Prompt engineering is emerging as a vital skill, and the better the prompt, the better the AI-driven output.DevOps Innovation Without Compromise: AutomatePro and ServiceNow are reshaping DevOps by making speed and quality compatible. Historically, faster releases meant riskier ones. With AutomatePro's intelligent testing automation, that tradeoff no longer exists. Frequent, smaller releases — the “fixed forward” model — are now safer thanks to early automation, embedded security, and contextual AI. Pope argues that platform owners and developers are the new heroes in enterprise IT, and equipping them with Copilots, intelligent workflows, and instant feedback loops unlocks untapped value.The Big Quote: "You're not going to be replaced by AI per se, you're going to be replaced by someone that knows how to use AI effectively."More from ServiceNow and AutomatePro:Follow AutomatePro on LinkedIn or learn more about ServiceNow and intelligent automation. Visit Cloud Wars for more.

Coruna Medical's Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement.Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environments and keeping people confident under pressure. He outlines the four-room model for inspection management, strategies for responding to observations, and proven methods for closing data-integrity gaps while daily operations continue.Jeff and Nick also explore the leadership mindset that sustains progress beyond the initial response—fostering transparency, prioritization, and a culture of accountability that prevents repeat findings.Topics discussed include:The leadership posture that steadies teams during inspections and remediationHow to stand up the four-room inspection model (Front, Back, Doc-QC, SME-Prep)Responding to 483s: when to push, when to accept, and how to align internallyData-integrity vulnerabilities and effective interim controlsBalancing remediation with production demandsBuilding transparency and accountability into quality cultureKeeping systems current to avoid backsliding into repeat observationsAbout The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/

Talked with Dr. Karen GIlbert, Vice President of Education and Quality Assurance for Alzheimer's Community Care in West Palm Beach, Florida.  She and Blake Davis will present how behaviors become a form of communication with folks living with dementia-related illnesses especially as the disease progresses at the upcoming Alzheimer's Foundation of America event.  "The Alzheimer's Foundation of America (AFA) will host a free Alzheimer's & Caregiving Educational Conference for South Florida residents on Wednesday, November 19 from 10:00 am to 1:00 pm ET at the Boca Raton Marriott at Boca Center (5150 Town Center Circle, Boca Raton). The free conference is open to everyone and will allow participants to learn from experts in the field of Alzheimer's disease, brain health, and caregiving. Register by visiting www.alzfdn.org/tour. Advance registration is highly recommended."  Listeners can also get info about local adult day services and the free lost on foot program at www.alzcare.org.

Yeast is the critical ingredient that turns humble wort into magical beer. This month, a look at the microbe from multiple angles and how to make the most out of it in your small-scale craft brewery.Guests: Laura Burns, Ph.D. is the Director of Research and Development at Omega Yeast. After studying stress responses in Saccharomyces cerevisiae for her graduate thesis at Vanderbilt University, she decided the best place to apply this knowledge was in brewing. She worked in production brewing for five years as Head Brewer and Director of Quality Assurance before heading back to the bench at Omega Yeast. Her undeniable curiosity drives her to tackle difficult questions that brewer's face daily. Technical Sales Manager for the home segment at Fermentis, Hugo Picard is in charge to support homebrewers, winemakers, cidermakers, in their hobby for beverage production at home. Hugo graduated with a Master's in Science and Agricultural Engineering from ISA Lille in France. He also acquired a Master's degree in International Marketing and Communication at Lille University. Before joining Fermentis, he has been president of a brewing and winemaking association and worked in several breweries and brewpubs in France and New-Zealand as a brewer or as a marketing/communication associate.The BYO Nano Podcast Episode 70  is sponsored by:BYO NanoCon on October 24Next week on Friday, October 24, learn from craft brewing industry experts with live online sessions covering Brewery Operations, Business Operations & Sales, and Start-Ups.• Full-Day of Live, Online Seminars and Q&A Panels• Access to Video Recordings and Course Materials for All Sessions• 3 Learning Tracks: Business & Sales, Brewing Operations, Start-Ups• Get Your Questions Answered Live by Craft Beer Experts• Interact with Other Small-Scale Craft Brewers & Breweries-In-Planning• Q&A Sessions with Leading Small-Scale Brewing Suppliers Check out https://byo.com/product/2025-nanocon-online/ for more details.BYO Nano+ MembershipGet access to hundreds of hours of on-demand videos covering small craft brewery strategies with BYO's Nano+ Membership. Learn from craft beer experts watching replays of past NanoCon seminars plus a complete library of in-depth workshops. You'll also have full online access to all of BYO's digital content and an annual digital magazine subscription. Check out byo.com/nanoplus for more details.BYO Nano Brew Podcast Episode 70Host: John HollGuests: Laura Burns, Hugo PicardContact: nano@byo.comMusic: Scott McCampbellPhoto: by John Holl

The FDA Group's Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization.With nearly 30 years of leadership experience spanning pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory, clinical, scientific affairs, and operations. He brings a rare, holistic view of how leadership, culture, and systems thinking come together to drive successful outcomes in complex, regulated environments.Their conversation explores how to balance innovation and compliance, structure cross-functional teams for consistent execution, and foster cultures that prioritize transparency, collaboration, and patient focus.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

The FDA Group's Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores FDA/ICH's new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. Regina explains why pregnant and breastfeeding women have historically been excluded from research, how that has left clinicians and patients with insufficient evidence, and why E21 represents a cultural and scientific shift toward safe, risk-based inclusion.Read the draft guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trialsRegina shares practical insights on:How physiologic changes in pregnancy alter drug absorption, distribution, metabolism, and elimination.The dangers of underdosing, overdosing, or avoiding treatment altogether in the absence of trial data.Why clinicians should avoid inappropriate substitutions (e.g., some NSAIDs) and instead rely on evidence-based dosing.How E21 encourages continued monitoring of participants who become pregnant during a trial rather than automatic withdrawal.The stepwise approach to lactation studies—starting with breast milk concentration, then estimating infant dose, and eventually assessing infant exposure and safety.The role of PK/PD modeling, nonclinical data, and real-world evidence in bridging evidence gaps.How sponsors can engage FDA early to align on inclusion triggers and maternal–fetal expertise.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

Healing from the Heart. In this episode of Your Next Mission® video podcast, SMA Tilley welcomes Claire Lawless, Former Senior Director, Quality Assurance & Brandi Salvatore, Case Manager, The Steven A. Cohen Military Family Clinic at Alaska Behavioral Health at Cohen Veterans Network. They highlight Cohen Veterans Network's mission to provide accessible, barrier free, high-quality mental health care for Veterans and their families.

God demands His people be about His work with faithful, obedience and excellence.

The FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to build the next generation of labs.Catherine explains the biggest challenges labs face today—like fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data, surface anomalies, and accelerate insights without replacing the people at the center of science. She outlines a step-by-step approach to identifying the right challenges, aligning AI projects with company strategy, piloting solutions with clear ROI, and managing change so teams embrace and sustain new tools.Nick and Catherine also discuss the balance between innovation and regulation, how to keep humans in the loop, and why strong governance and explainability are essential to ensuring AI adds real value in GLP environments.About The FDA Group: The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/

The FDA Group's Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.Jeff shares why inspections feel less predictable today—with more variability in inspector experience and a higher likelihood that minor issues become formal observations—and how leaders can respond without overreacting. He explains how to prepare documentation so that it's understandable to any inspector, what makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance.Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don't overburden teams, and fostering engagement so quality is seen as a partner, not just a policing function.About The FDA Group: The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

“If you're a professional and the rules of your profession change, you can't afford not to keep up.”  — Scott Doyle   In this episode of the RESTalk podcast, host Bill Spohn sits down with two long-time leaders at RESNET

In this episode of Fresh Perspectives in Social Work, Lisa Roberts, Manager in BerryDunn's State Government Practice Group sits down with Cammie Chapman, Special Counsel with Brown & Peisch and the former Deputy Secretary of West Virginia's Department of Human Services, to explore how developing and implementing a robust quality assurance program can support the legal defense in class action lawsuits involving the American with Disabilities Act (ADA). You'll hear insights on the importance of quality assurance overall, as well as a deeper dive into how states can use a continuous quality improvement process to positively benefit the children, youth, and families they serve. Whether you're a social worker, state government leader, or compliance officer, this episode offers practical tips that will benefit your staff and the communities you serve.

The FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olympus, Covidien, JUUL Labs, and others, Marcus brings a unique perspective to what makes a quality organization truly high-performing.Marcus shares why compliance is only the baseline “entry fee” for quality—and how high-functioning teams go further by protecting a company's right to compete, preventing manufacturing and supply disruptions, enabling speed to market, and building trust across the business.He discusses the metrics that matter most (like defect rates, back orders, holds, complaints, and R&D delays), how to structure incentives that drive the right behaviors, and practical strategies for recruiting, onboarding, and retaining people with the drive, courage, and creativity to lead meaningful change.Nick and Marcus also explore how leaders can create the right balance of accountability and innovation, foster collaboration across functions, and ensure quality is seen as a value-driving partner rather than a cost center or policing function.About The FDA Group:The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

Behind the scenes at Disney, it's leadership that truly runs the show. In this episode, Lee Cockerell shares the surprising leadership secrets that helped him oversee 40,000 cast members as the former VP of Operations for Walt Disney World Resort. From his time at Hilton, Marriott, and Disney, he breaks down the habits and leadership principles that helped him become one of the industry's most respected leaders. You'll learn what it takes to be successful in any role, why routines matter more than you think, and how to become the kind of leader people want to work with. Topics discussed: How Lee built his career with no college degree What he learned working at Hilton and Marriott Why some leaders fail How his leadership style has evolved The habits and mindset that made him successful The legacy of his book, Creating Magic: 10 Common Sense Leadership Strategies from a Life at Disney Resources: Mitlin Financial: https://www.mitlinfinancial.com/ The JOY and Productivity Journal by Lawrence Sprung: https://www.amazon.com/JOY-Productivity-Journal-brought-mindset/dp/B0CYQFYW54/ Download Your Free Copy of the Couple's JOYful Money Guide: https://mitlin.us/CouplesJOY Connect with Larry Sprung:  LinkedIn: https://www.linkedin.com/in/lawrencesprung/ Instagram: https://www.instagram.com/larry_sprung/ Facebook: https://www.facebook.com/LawrenceDSprung/ X (Twitter): https://x.com/Lawrence_Sprung Connect with Lee Cockerell: LinkedIn: https://www.linkedin.com/in/LeeCockerell/ Instagram: https://www.instagram.com/leecockerellmagic/ Facebook: https://www.facebook.com/p/Lee-Cockerell-100070689116367/ Creating Disney Magic Facebook: https://www.facebook.com/createmagic/ Personal Website: https://www.leecockerell.com/ Cockerell Academy Website: https://www.cockerellacademy.com/ About our Guest: Lee Cockerell retired as the Executive Vice President of Operations for the WALT DISNEY WORLD® Resort in Lake Buena Vista, Florida, a position he held for ten years. His responsibilities encompassed a diverse mix of operations, which included 20 resort hotels with over 24,000 Guest rooms, 4 theme parks, 2 water parks, 5 golf courses, a shopping village & nighttime entertainment complex, the ESPN Sports Complex and the ancillary operations support functions. Lee joined the Disney organization in July 1990 as Director of Food and Beverage and Quality Assurance for the Disneyland Paris hotels. Prior to joining the Walt Disney World Co., he spent seventeen years in various executive positions with the Marriott Corporation and eight years with Hilton Hotels. Lee is the best-selling author of four books on leadership, management and world class customer service: Creating Magic: 10 Common Sense Leadership Strategies from a Life at Disney is now available in 21 languages. The Customer Rules: The 39 Essential Rules for Delivering Sensational Service is currently available in 15 languages. Time Management Magic: How to Get More Done Every Day Career Magic: How to Stay on Track to Achieve a Stellar Career Lee and his wife Priscilla reside in Orlando, Florida. Lee enjoys teaching leadership, management and service excellence seminars, traveling, dining out and most of all spending time with his three grandchildren, Jullian, Margot, and Tristan. Disclosure: Guests on the Mitlin Money Mindset are not affiliated with CWM, LLC, and opinions expressed herein may not be representative of CWM, LLC. CWM, LLC is not responsible for the guest's content linked on this site. This episode was produced by Podcast Boutique https://www.podcastboutique.com

AI is evolving so fast that it's hard to keep up—sparking both excitement and anxiety about the future of work. Will AI replace jobs, or will it redefine them?In this episode of [Un]churned, host Josh Schachter, SVP of Atlas at Gainsight, sits down with Jeffrey Bussgang, General Partner & Co-Founder at Flybridge Capital Partners and Senior Lecturer at Harvard Business School, and Teresa Anania, Chief Customer Officer at Sophos, who's been leading from the frontlines of AI-driven customer engagement. Together, they unpack the gap between the theory of AI transformation and the reality of implementation in large organizations. Jeff discusses how leaders can foster an “AI native” culture—one that encourages experimentation while valuing human judgment. Teresa shares a candid look into Sophos' AI journey, addressing the fears, resistance, and cultural shifts that come with change. She also highlights practical strategies to empower teams and enhance customer experiences through thoughtful automation.Whether you're a tech leader, customer success pro, or just AI-curious, this conversation is packed with actionable insights on embracing the future without losing the human touch.Timestamps: 0:00 - Preview0:48 - Meet Jeff & Teresa2:40 - The Impact of AI on Business Innovation5:00 - Fostering an AI-Driven Culture to Elevate Workforce Value16:10 - How AI Enables Rapid Prototyping19:40 - Balancing Human and AI Workflows21:50 - Quality Assurance and Customer Experience at Scale27:50 - Internal “Agent Assist” Solutions35:07 - Dynamics in Adopting AI Solutions______________________

I talk about last week's balance changes and my deck choices on he climb to Legend this month, before playing Mech Warrior on the ladder. You can find the deck import code below the following contact links.  You can follow me @blisterguy on Twitch, Bluesky, and Youtube. Join our Discord community here or at discord.me/blisterguy. You can support this podcast and my other Hearthstone work at Patreon here. # 2x (1) Slam # 1x (2) Crazed Alchemist # 2x (2) Part Scrapper # 1x (2) Quality Assurance # 2x (2) Safety Goggles # 2x (2) Shield Block # 2x (3) All You Can Eat # 2x (3) Boom Wrench # 2x (3) Mixologist # 2x (3) Wreck'em and Deck'em # 1x (4) Elise the Navigator # 1x (4) Nightmare Lord Xavius # 2x (5) Carnivorous Cubicle # 2x (5) Chemical Spill # 2x (6) Testing Dummy # 1x (7) Endbringer Umbra # 1x (8) Inventor Boom # 1x (0) Zilliax Deluxe 3000 #   1x (0) Zilliax Deluxe 3000 #   1x (4) Virus Module #   1x (5) Perfect Module # 1x (10) Tortolla #  AAECAZTxBgidoATHpAaRqAaTqAax/QbDgweCmAf1mAcLhqAEjtQE6J8Gh6AGj6gGkKgGkqgGlKgGhr8Gjr8GiuIGAAED9LMGx6QG97MGx6QG7t4Gx6QGAAA=

In this episode of PPC Live, Reva Minkoff shares her extensive experience in digital marketing, focusing on the importance of learning from mistakes in PPC campaigns. She discusses a significant error made during a Performance Max campaign, how it was turned into a learning opportunity, and the importance of understanding client goals. Reva emphasizes the need for a supportive environment where team members can share their failures and learn from them. The conversation also touches on the challenges posed by AI in PPC and the necessity of maintaining control over campaigns to align with client expectations.Takeaways:Learning from mistakes is crucial in digital marketing.Understanding client goals is key to successful PPC campaigns.Creating a supportive environment encourages team members to share failures.AI can introduce challenges in PPC that require careful management.Mistakes can lead to valuable learning opportunities.It's important to focus on what truly matters to clients.Communication with clients about mistakes can strengthen relationships.A structured QA process can help prevent errors in campaigns.Collaboration with other marketing teams enhances PPC effectiveness.Embracing a culture of learning from failures can drive success.Chapters00:00 Introduction to Reva Minkoff and Her Background03:55 The Importance of Learning from Mistakes07:54 Navigating Client Relationships and Expectations11:58 Understanding Client Goals and Metrics15:49 The Role of Collaboration in Marketing Success19:20 Navigating Campaign Goals and Conversions22:38 The Importance of Quality Assurance in Campaigns24:30 Creating a Safe Environment for Mistakes26:28 Learning from Failures and Client Goals28:13 The Role of AI in PPC Campaigns33:20 Reflections on a PPC Career JourneyFind Reva on LinkedInBook a coaching call with ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Anu⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠PPC Live The Podcast (formerly PPCChat Roundup) features weekly conversations with paid search experts sharing their experiences, challenges, and triumphs in the ever-changing digital marketing landscape.The next ⁠⁠⁠⁠⁠⁠⁠⁠⁠PPC Live London⁠⁠⁠⁠⁠⁠⁠⁠⁠ event is on October 22ndFollow us on ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow us on ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Twitter⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Join our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠WhatsApp Group⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Subscribe to our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Newsletter⁠

The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one directly impacts growth, culture, and execution.Listeners will learn how to:Pressure-test whether your strategy is actually winnable.Match organizational capabilities to goals (and pivot when they don't).Use KPIs and OKRs to diagnose execution gaps.Build stronger trust and culture through connectedness, from “gemba” walks to multi-channel communication.Sean also shares real-world stories—from transforming an underperforming ultrasound launch to shifting a company's culture from “play not to lose” to “play to win.” Whether you're leading in medtech, life sciences, or beyond, this episode delivers actionable insights you can bring straight back to your team.About the Guest:Sean Gallimore, MBA is an executive consultant with 30 years of leadership across Fortune 500, mid-cap, and private equity–backed companies in medical devices, life sciences, and industrial technology. He has held senior roles at Medtronic, Smith & Nephew, Philips, Parexel, PDI Healthcare, and Dynisco, driving growth through strategy execution, turnarounds, innovation, and building high-performing teams. Today, he advises early-stage medtech companies on scaling operations, commercial strategy, and organizational development.About The FDA Group:The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

August 13, 2025: Eric Utzinger, Co-Founder and Chief Client Officer at Revuud, tackles the world of healthcare consulting. Drawing from 15 years in healthcare consulting, Eric reveals how the industry shifted around 2013, creating a system where traditional staffing firms often add little value beyond letterhead while charging substantial markups. What happens when technology enables direct access to pre-vetted talent pools? The conversation explores how marketplace platforms can eliminate intermediary costs while maintaining quality control, and why the assumption that higher costs equal better consultants may be costing health systems more than they realize. Eric addresses the critical balance between project success, talent vetting, and transparent pricing in an industry where finding the right IT expertise quickly can make or break major implementations. Key Points: 02:08 Challenges in Healthcare Consulting 04:53 Client and Talent Interaction 06:52 Vetting and Quality Assurance 09:56 Common Mistakes in Hiring Contractors X: This Week Health LinkedIn: This Week Health Donate: Alex's Lemonade Stand: Foundation for Childhood Cancer

Is your QA team really slowing down delivery, or are they just revealing the cracks in your development process? In this episode of Arguing Agile, we're talking about one of the most persistent myths in software development and reveal why QA teams are often unfairly blamed for systemic issues.We explore:The shift-left movement and why QA belongs in customer conversationsHow collaboration breakdowns create false bottlenecks Why treating QA as a cost center backfiresReal strategies for breaking the cycle of blameThe hidden value QA brings to lean startup principlesFrom waterfall thinking to modern agile practices, we break down why QA teams are actually your best allies in creating customer value - if you let them.#QualityAssurance #AgileCoaching #ProductManagementREFERENCESArguing Agile 211 - Communication is Product's Only Job)Arguing Agile 201 - Mastering Stakeholder Communication and ManagementArguing Agile 199 - W. Edwards Deming's Profound Knowledge for Transforming OrganizationsLINKSYouTube https://www.youtube.com/@arguingagileSpotify: https://open.spotify.com/show/362QvYORmtZRKAeTAE57v3Apple: https://podcasts.apple.com/us/podcast/agile-podcast/id1568557596Website: http://arguingagile.comINTRO MUSICToronto Is My BeatBy Whitewolf (Source: https://ccmixter.org/files/whitewolf225/60181)CC BY 4.0 DEED (https://creativecommons.org/licenses/by/4.0/deed.en)

In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you're a hiring manager, candidate, or aspiring recruiter in the life sciences or medtech industries, this episode is packed with honest insights and practical advice. What you'll learn: Why Mitch chose to specialize in QA/RA The tension between client expectations and candidate realities How recruiters make their revenue (yes, we ask the money question!) Whether promoting open positions is still a challenge in 2025 Mitch's personal journey—education, family, and the struggles of building a business from scratch What he would do differently if he had to start again Whether you're considering using a recruiter or dreaming of launching your own hiring firm, this episode will help you understand what it really takes to go "from zero to one."

Ep 613 features Jen, a Quality Assurance and Training Manager with Chagrin Valley 911 Dispatch out of Ohio. Sponsored by INdigital - Facebook | LinkedIn | Twitter | Web Episode topics – Jen's path from criminal justice student to finding a lasting career in dispatch. The highs and lows of dispatcher training, including tough trainers and the importance of mentorship. Real stories about adapting to regionalized dispatch operations and handling high-stress situations. Calls that stick with dispatchers–from tragic emergencies to unexpectedly emotional moments. Lessons learned, advice for new dispatchers, and how the profession shapes the people behind the headset. If you have any comments or questions or would like to be a guest on the show, please email me at wttpodcast@gmail.com.

On this episode of the Inner Edison Podcast, host Ed Parcaut sits down with Leeroy Beeby, chartered accountant, entrepreneur, and founder of Checkthelevel.com—to talk about the real-world struggles and solutions in the world of small business finance. Leeroy shares his journey from South Africa to Bermuda to Canada, and how growing up in a family of serial entrepreneurs shaped his drive for innovation. He opens up about the challenges of building and managing remote teams, how introverts thrive in entrepreneurship, and the lessons learned from hiring (and firing) fast. Most importantly, Leeroy unpacks the most frequent—and expensive—bookkeeping mistakes businesses make, and how his company's “Grammarly for bookkeeping” is helping owners and bookkeepers catch errors before they snowball. You'll hear actionable advice for entrepreneurs and accounting professionals alike, plus candid takes on the reality of AI in bookkeeping, remote work culture, and why sustainable growth matters more than just getting bigger. Ready to feel more confident about your books? Grab your headphones and get ready to learn, laugh, and start seeing your financials in a whole new light! Try Checkthelevel.com with a 30-day free trial (no credit card required), and connect with Leeroy on LinkedIn or by emailing contact@checkthelevel.com. **Contact Ed Parcaut:** -

Metis Consulting Services ML Bradley welcomed Kara Harrison to the "Queens of Quality" podcast, where Kara Harrison shared her extensive career journey in quality assurance, from the USDA and FDA to various consulting roles. Both Kara Harrison and Metis Consulting Services ML Bradley discussed the evolution of the consulting industry, emphasizing the importance of clear client scope and the challenges posed by clients who insist on incorrect approaches. A key talking point centered on the misconception among sponsors that outsourcing absolves them of responsibility, particularly concerning vendor qualification and oversight, which directly contradicts regulatory guidelines such as ICH E6R3.

The FDA Group's Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a wide-ranging conversation about how real-world data is reshaping drug development, regulatory decisions, and public understanding of evidence.Dr. Stapff draws on decades of experience across medical affairs, clinical trials, and RWE analytics to explain why real-world evidence isn't a replacement for randomized controlled trials—but a necessary complement. He outlines how to transform raw data into credible evidence, how the FDA is using RWE today, and why quality, transparency, and context are essential in data-driven science.He also offers cautionary insight on common pitfalls—from bias in training data and misinterpreted statistics to the challenges of AI integration in healthcare research.What they cover:What real-world evidence is (and isn't)—and how it differs from clinical trial dataHow RWE is being used by the FDA to support label expansions and safety monitoringKey risks around self-reported data, upcoding, and poor data qualityWhy statistical significance isn't enough—and how to evaluate clinical relevanceHow AI can accelerate pattern recognition and predictive diagnosticsWhy training data matters—and how bias can infiltrate large-scale AI toolsThe role of educated skepticism in interpreting data-driven claims in both science and societyDr. Manfred Stapff is the founder and principal consultant at a boutique advisory firm focused on real-world evidence strategy, clinical development, and medical data intelligence. He is the author of Real World Evidence Unveiled and a frequent speaker on the role of data integrity, statistical literacy, and AI in advancing medical research. His current work supports life science companies and investors in evaluating drug development strategies, acquisition opportunities, and data-driven innovations.The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com⁠⁠

I discuss my top 5 cards from the Lost City of Un'Goro, before playing Mech Warrior on the ladder. You can find the deck import code below the following contact links.  You can follow me @blisterguy on Twitch, Bluesky, and Youtube. Join our Discord community here or at discord.me/blisterguy. You can support this podcast and my other Hearthstone work at Patreon here. # 1x (1) Sanguine Depths # 1x (2) Crazed Alchemist # 2x (2) Part Scrapper # 2x (2) Quality Assurance # 2x (2) Safety Goggles # 2x (2) Shield Block # 1x (2) Youthful Brewmaster # 1x (3) All You Can Eat # 2x (3) Boom Wrench # 1x (3) Latorvian Armorer # 1x (3) Mixologist # 1x (3) Wreck'em and Deck'em # 1x (4) Elise the Navigator # 1x (4) Griftah, Trusted Vendor # 1x (4) Nightmare Lord Xavius # 1x (4) Royal Librarian # 1x (5) Carnivorous Cubicle # 2x (5) Chemical Spill # 2x (6) Testing Dummy # 1x (7) Endbringer Umbra # 1x (8) Inventor Boom # 1x (0) Zilliax Deluxe 3000 #   1x (0) Zilliax Deluxe 3000 #   1x (4) Virus Module #   1x (5) Perfect Module # 1x (10) Tortolla #  AAECAZTxBhCcoASdoATOngbHpAaQqAaTqAaGvwaOvwan0waK4gbj5gax/QbDgweCmAeLmAf1mAcHjtQE6J8Gh6AGj6gGkagGkqgGlKgGAAED9LMGx6QG97MGx6QG6t4Gx6QGAAA=

Zendesk CEO Tom Eggemeyer joins Michael Krigsman to discuss the impact of AI CX on customer expectations. They explore real-world lessons from the Zendesk AI journey, including what has worked and what hasn't. Learn how customer service is being reshaped by ChatGPT and artificial intelligence and machine learning.Key Topics Covered:The shift from traditional chatbots to reasoning AI agentsWhy Zendesk only gets paid when AI successfully resolves issuesHow AI is more accurate (and sometimes more empathetic) than humansThe surprising ways AI is changing customer service metricsReal-world examples of AI successes and failuresThe future of work in an AI-dominated landscape

Try Fellow's AI Meeting Copilot - 90 days FREE - fellow.app/cooGuest: Lance Willett, Chief Quality Officer at AutomatticTopics Covered:How Automattic's open source culture evolved over 20 yearsWhat a Chief Quality Officer actually does—and why it mattersQuality = Craft × Context, and how that feedback loop scalesAutomattic's AI strategy: support bots, contextual UI, and site generationThe importance of tools like Linear and Storybook in enforcing qualityHow Automattic balances speed, risk, and governance with AI experimentationLessons from stabilizing Tumblr during its post-acquisition rebootPrioritization and the dangers of unbounded optimismLeadership takeaways from working closely with Matt Mullenweg

The HITRUST 2025 Trust Report sheds light on a critical question organizations continue to ask: can you really rely on a certification to mean what it says? According to Vincent Bennekers, Vice President of Quality, and Bimal Sheth, Executive Vice President of Standards Development and Assurance Operations at HITRUST, the answer comes down to one word: reliability.The conversation highlights how HITRUST goes beyond a simple checklist by layering in both threat intelligence and maturity modeling. Their framework isn't just built on abstract risk—it incorporates real-world attack techniques, aligning controls to the MITRE ATT&CK framework. This means that the certification reflects actual adversarial tactics rather than hypothetical risk scenarios.Bennekers shares that 99.41% of HITRUST-certified organizations did not report a breach in the last year, and that consistency over two annual reports points to meaningful outcomes—not just marketing claims. Sheth explains how each certification is reviewed in full by HITRUST, not just sampled, and every control is assessed for maturity—not pass/fail. It's a model that helps companies continuously improve, while also giving relying parties better information.For executive teams and boards, the report surfaces where organizations commonly struggle, including access control, vulnerability management, and third-party risk. It also highlights a growing use of external inheritance—leveraging cloud service providers' security posture—as a strategic move for organizations with tighter budgets.Looking ahead, the conversation points to continuous assurance and the evolving role of AI—both as a source of new risks and a tool to enhance security operations. HITRUST is already exploring certification models that reduce drift and increase visibility year-round.For organizations wanting to build more than just a paper shield, this episode unpacks how certification—done right—can be a strategic, measurable advantage.Note: This story contains promotional content. Learn more.Guests:Bimal Sheth, Executive Vice President of Standards Development and Assurance Operations at HITRUST | On LinkedIn: https://www.linkedin.com/in/bimal-sheth-248219130/Vincent Bennekers, Vice President of Quality at HITRUST | On LinkedIn: https://www.linkedin.com/in/vincent-bennekers-a0b3201/Host:Sean Martin, Co-Founder at ITSPmagazine and Host of Redefining CyberSecurity Podcast | https://www.seanmartin.com/______________________Keywords: sean martin, bimal sheth, vincent bennekers, hitrust, trust report, cybersecurity, compliance, certification, quality assurance, risk management, brand story, brand marketing, marketing podcast, brand story podcast______________________ResourcesHITRUST 2025 Trust Report: https://itspm.ag/hitrusz49cWebinar: Beyond the Checkbox: Rethinking SOC 2, Cybersecurity, and Third-Party Risk in 2025 — An ITSPmagazine Webinar with HITRUST (https://www.crowdcast.io/c/beyond-the-checkbox-rethinking-soc-2-cybersecurity-and-third-party-risk-in-2025-an-itspmagazine-webinar-with-hitrust)Visit the HITRUST Website to learn more: https://itspm.ag/itsphitwebLearn more and catch more stories from HITRUST on ITSPmagazine: https://www.itspmagazine.com/directory/hitrustLearn more about ITSPmagazine Brand Story Podcasts: https://www.itspmagazine.com/purchase-programsNewsletter Archive: https://www.linkedin.com/newsletters/tune-into-the-latest-podcasts-7109347022809309184/Business Newsletter Signup: https://www.itspmagazine.com/itspmagazine-business-updates-sign-upAre you interested in telling your story?https://www.itspmagazine.com/telling-your-story

  Background: From IT in India to MedTech in Norway  You have a pretty fascinating background – you studied computer applications/IT back in India and now you're a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)  What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?  And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)  Day-to-Day as a QARA Manager   Let's talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)  It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?  We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?  On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?  (For example, is it challenging that the scope is so broad – one moment you're deep in engineering specs, next moment you're updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)  First MedTech Role at Hy5Pro AS  Let's dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?  (Feel free to explain what Hy5Pro's product was and your role there, e.g. implementing the quality system, getting certifications, etc.)  Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?  (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)  Leading QARA at RemovAid AS   After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?  RemovAid's product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.  (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)  On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?  RemovAid is in women's health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it's about making contraceptive care easier – that's quite impactful.)  Consulting Experience at LINK Medical   Now, currently you're working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?  I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company's project mid-stream.  Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you've learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*  Diversity and International Career Insights   I'd like to touch on diversity and your international experience. You're a woman in the medtech industry and you've built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you've noticed working in Norway compared to India?  The medtech industry, especially in leadership, still isn't very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?  What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)  Rapid-Fire Round   Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I'll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!  Question 1: What's one thing about your job that most people would be surprised to learn?  Question 2: What's the coolest medical device or gadget you've worked on or seen so far?  Question 3: Are you team coffee or tea? (What fuels your workdays?)  Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?  Question 5: If you weren't in QARA, what alternate career could you see yourself in?  Question 6: What's one Norwegian word or phrase you've picked up that you love to use? (Bonus: translate it for us!)*  Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)  (Guest gives rapid-fire answers with laughter and brief commentary.)  Advice and Closing   Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?  (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)  And maybe equally important, what should they not be scared of? People might think “Oh, I'm not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?      Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)  Welcome & Setup  Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?  Career Journey  How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?  What motivated you to switch into medical device regulations, and what were the biggest initial challenges?  In what ways has your IT background helped you excel in QARA?  Day-to-Day Responsibilities  What does a typical day or week look like for you as a QARA Manager?  Which tools or software (QMS systems, document controls, etc.) do you rely on most?  Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it's all paperwork?  Which aspects of QARA do you find most challenging, and which are the most rewarding?  Hy5Pro AS Experience  What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?  Can you share a memorable “learning moment” or funny anecdote from your time there?  RemovAid AS Experience  At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?  Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.  Any unexpected or humorous challenges you overcame in that role?  How did working on a women's health product impact you personally?  LINK Medical Consulting  How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?  What's a standout project or recurring compliance issue you help clients solve?  How do you stay organized when juggling multiple clients and deadlines?  Diversity & International Insights  As a woman in medtech QARA, have you faced any unique challenges or opportunities?  What cultural adjustments did you experience moving from India to Norway?  How can medtech teams become more inclusive, especially in QA/RA?  Rapid-Fire Round  (Answer quickly with the first thing that comes to mind.)  One surprise fact about your job?  Coolest device or gadget you've worked on or seen?  Favorite (or funniest) QARA acronym—what does it mean?  Alternate career you might have chosen?  Norwegian word or phrase you love—translate it for us!  If your career were a movie title, what would it be?  Closing Advice  What practical steps should students or career-changers take to break into QARA?  What misconceptions shouldn't they be afraid of when considering this field?   

The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: the cost of quality.Dr. Garko shares why quality should be viewed not as a cost center but as a strategic investment—and how companies can embed that mindset into their culture, systems, and leadership practices. She outlines the difference between good and poor quality costs, explains how to build ROI-focused metrics, and offers practical ways to foster transparency, psychological safety, and proactive decision-making.From regulatory intelligence and scorecard design to audit readiness and AI integration, this conversation is packed with insights for quality leaders and executive teams alike.What they cover:How to shift your organization's mindset from compliance to value creationThe real financial and operational impact of poor vs. proactive qualityHow to build scorecards, systems, and reporting processes that drive actionWhy culture, transparency, and psychological safety are core to sustainable qualityPractical approaches to audit readiness, supplier oversight, and training_____The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com/

On Episode #173 of the PricePlow Podcast, Mike and Ben dive deep into the world's most researched supplement with Mirko Holzmüller and Stefan Schweyer from Creapure, the premium creatine monohydrate brand manufactured by AlzChem in Germany. This comprehensive conversation explores everything from the unique German manufacturing process that delivers 99.99% purity to the expanding research showing creatine's benefits far beyond athletic performance. As creatine experiences a renaissance with growing interest from women, elderly populations, and health-conscious consumers, Mirko and Stefan provide insider insights into what sets Creapure apart from generic alternatives. From the coal-and-lime production process in Bavaria to the rigorous testing protocols that ensure every batch meets pharmaceutical-grade standards, this episode reveals why leading brands like Nutristat choose Creapure as their exclusive creatine source. The discussion covers optimal dosing strategies, debunks common myths about loading phases, and explores emerging research on post-viral fatigue, cognitive function, and healthy aging. Whether you're a supplement industry professional or someone curious about creatine's expanding applications, this conversation offers unprecedented access to the science and manufacturing expertise behind the world's most trusted creatine brand. https://blog.priceplow.com/podcast/creapure-173 Video: Inside Creapure - The Science of Premium Creatine Manufacturing https://www.youtube.com/watch?v=rJe2nesRtkw Detailed Show Notes: Creapure's Manufacturing Excellence and Scientific Leadership (0:00) – Introduction: Meeting the Creapure Team (5:00) – AlzChem's Foundation: More Than Just Creatine (10:00) – Creatine Fundamentals: Energy Currency for Body and Brain (15:00) – Personal Dosing Strategies: Beyond the Standard Five Grams (20:00) – Understanding Creatine's Unique Energy Profile (25:00) – Manufacturing Excellence: The German Advantage (30:00) – Purity Standards: 99.99% Excellence (35:00) – Quality Control and Contamination Prevention (40:00) – Market Trends and Consumer Education (45:00) – Research Partnerships and Scientific Leadership (50:00) – Creatine Forms and Research Evidence (55:00) – Practical Use and Dosing Strategies (60:00) – Product Forms and Delivery Methods (65:00) – Quality Assurance and Brand Protection (70:00) – Regulatory Compliance and Health Claims (75:00) – Future Directions and Consumer Access Where to Follow Creapure and Learn More Creapure Website: Creapure.com Instagram: @Creapure Email: info@creapure.com Mirko Holzmüller: LinkedIn Stefan Schweyer: LinkedIn Educational Resources: Creapure Manufacturing Process AlzChem Company Overview ... Read more on the PricePlow Blog

Nick Capman talks with Marcia Baroni—a microbiologist with 27 years in global pharma-quality leadership—about reframing quality from a controllable expense to a strategic asset. Baroni contrasts “bad-quality” costs (scrap, recalls, deviations) with “good-quality” investments (testing, preventive controls, oversight) and explains why the latter pay for themselves in resilience and brand value. She illustrates the stakes with a $600 million nationwide OTC-drug recall caused by chemically treated pallets—an error frontline staff flagged but a weak quality culture ignored. The conversation dives into building psychological safety and metrics that drive the right behaviors, not under-reporting, shifting quality from “policing” to cross-functional partnership, and practical first steps executives can take to gauge their current maturity and start investing for future yield._____The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com/

TakeawaysQuality assurance is crucial in coffee roasting.Cupping is essential for coffee quality.You need to taste your own coffee.Cupping should be a priority in your business.Learn to cup, then cup to learn.Make cupping enjoyable and accessible.Invest in basic quality control tools.Cupping with peers enhances learning.Practice is key to improving your cupping skills.Production brewing can be more effective than cupping.   Visit and Explore Covoya! TAKE OUR LISTENER SURVEY

Dr. Renee Coffman is president and co-founder of the Nevada College of Pharmacy, now Roseman University of Health Sciences. She previously served as the University's Executive Vice President for Quality Assurance and Intercampus Consistency and the Dean of its College of Pharmacy. Before establishing Roseman University, Dr. Coffman became a founding member of the faculty at Western University of Health Sciences, where she also held the position of Facilitative Officer for Student Services. While at Western, Dr. Coffman and four colleagues received Honorable Mention for the AACP Innovations in Teaching Awards. A licensed pharmacist in the state of Nevada, Dr. Coffman earned a Pharmacy degree from OhioNorthern University in 1987 and, following graduation, worked as a pharmacist in her hometown of Bucyrus, Ohio and in Piqua, Ohio. In 1995, Dr. Coffman earned a doctoral degree in Industrial and Physical Pharmacy from Purdue University, where she received the Kienle Award for Excellence in Teaching, the Jenkins-Knevel Award for Outstanding Graduate Research, and was awarded an AAPE-AFPE Association Fellowship in Pharmaceutical Sciences.Dr. Coffman is a member of the American Association of Colleges of Pharmacy, American Pharmaceutical Association, American Association of Pharmaceutical Scientists, the American Society of Health System Pharmacists, and the International Federation of Pharmacy, as well as Phi Kappa Phi and Rho Chi Honor Societies and the Phi Lambda Sigma Pharmacy Leadership Society. Dr. Coffman has worked to support pharmacy, education, and improved health care through herwork with the Southern Nevada Medical Industry Coalition, iDO (Improving Diabetes and Obesity inSouthern Nevada), the Nevada State Board of Pharmacy Medication Error Discussion Group, and theNevada State Board of Pharmacy Committee on Standards for Approval of Pharmacy Technician Training Programs. Additionally, Dr. Coffman was instrumental in successful legislative efforts permitting pharmacists to perform finger-stick blood glucose testing. In recognition of her community service in Southern Nevada, in 2008, she received the “Who's Who in Healthcare” Award and the “Women of Distinction” Award, both sponsored by In Business Las Vegas, now VEGAS INC. In 2017, the publication recognized Dr. Coffman as one of 12 “Women to Watch” in business. In 2012, she was named a “Distinguished Alumnus” by Ohio Northern University and in 2021 was named a “Distinguished Alumnus” by Purdue University.

In this episode of the Drop In CEO podcast Jay Schumann shares his expertise in corporate microbiology, food safety, and quality assurance. The conversation covers Jay's career journey, key leadership lessons, and the importance of being a lifelong learner. Jay emphasizes the value of humility, continuous learning, and investing in people, offering practical advice for both current and aspiring C-Suite leaders. The episode also highlights the significance of aligning with a company's values and the critical role of cultural understanding in achieving professional success. Episode Highlights: 05:31 Climbing the Corporate Ladder at PepsiCo 09:46 Insights on Leadership and People Management 23:53 Defining Lifelong Learning and Wisdom 25:48 Acquiring Knowledge Through Various Methods 29:28 The Role of Humility in Learning and Leadership 36:53 Finding Credible Sources of Information Jay Schuman is a seasoned senior leader in Corporate Food Safety and Microbiology with over 30 years of experience in the food and beverage industry. Known for his high integrity and science-based, practical approach, Jay has led global teams and labs supporting new product innovation, risk mitigation, compliance, and quality assurance for major CPG brands. He excels at designing and implementing microbial food safety programs, harmonizing standards across regions, and fostering GFSI-compliant food safety cultures. A trusted people leader and strategic thinker, Jay is passionate about cross-functional collaboration, continuous improvement, and building strong, values-driven teams that drive business results. Connect with Jay Schuman: LinkedIn: www.linkedin.com/in/jay-schuman For more information about my services or if you just want to connect and have a chat, reach out at: https://dropinceo.com/contact/See omnystudio.com/listener for privacy information.

In today's episode, Adrian is joined by Andrew Amirnovin, our reliability expert, and we're using Tesla's Cybertruck problems as a case study in what happens when a product skips, or underinvests in, reliability testing. From panels that fall off to cracked windshields and sticky accelerator pedals, it's clear the fundamentals weren't locked down before launch. We'll unpack the engineering missteps that led to mass recalls, the fallout from Elon Musk's political distractions, and most importantly, the lessons this holds for manufacturers, startups, and scale-ups.   Show Sections 00:00:00 – Intro: Tesla's Reliability Crisis 00:02:04 – The Cybertruck's Troubling Launch 00:05:38 – Issues with Tesla's Engineering 00:09:14 – Financial Fallout from Political Drama 00:10:36 – The 4-Year Development Timeline. Too Rushed? 00:19:40 – Quality Assurance and Gate Reviews 00:22:25 – Industry Case Studies: Lessons from Ford, Toyota & Airbag Failures 00:31:30 – Lessons for All Manufacturers 00:33:45 – Closing Thoughts on Reliability Testing   Related content... How the Cybertruck Came to Embody Tesla's Problems (WSJ) Cybertruck's Many Recalls Make It Worse Than 91 Percent of All 2024 Vehicles (Wired) I Bought My Dream Car And It SUCKS Here's Why… Cybertruck Problems (Video) Top 5 Reliability Testing Methods for New Products HALT vs. HASS – What's the Difference? Design Validation Plan for Reliability Testing Why Reliability Testing Is Critical for Electronic Products How to Improve Product Reliability Before Launch Product Reliability Testing | 7 FAQs Why Product Safety, Quality, and Reliability Are Tightly Linked   Get in touch with us Connect with us on LinkedIn Contact us via Sofeast's contact page Subscribe to our YouTube channel Prefer Facebook? Check us out on FB Get in touch with us Connect with us on LinkedIn Contact us via Sofeast's contact page Subscribe to our YouTube channel Prefer Facebook? Check us out on FB

In this episode, Raul dives into the journey of Cynthia Abbott Kerr and Richard Kerr, the power couple behind Wellpay AI. Cynthia, a former corporate executive, shares how a trip to Japan and Rich's encouragement led her to start a business focused on helping other companies design and align their pay strategies using AI. The discussion touches on the complexities of building an AI-driven company, especially in a highly regulated industry, and how Wellpay AI addresses these challenges. Richard brings his extensive AI expertise to the table, emphasizing the importance of security and continuous learning in their technology. They also explore the future of work, how AI is transforming traditional roles, and the essential skills needed in this evolving landscape. Tune in to learn about their innovative approach to compensation consulting and the role of AI in making strategic business decisions.00:16 Cynthia's Journey to Founding Wellpay AI01:54 Building an AI Company: Challenges and Strategies03:13 AI in Compensation: Ethics and Compliance03:56 Rich's Expertise in AI Development05:35 Strategic Use of AI in Business10:41 Business Model and Pricing Strategy16:40 Quality Assurance in AI Systems18:08 Communicating Value to Clients18:37 Efficiency and Speed in Consultancy20:38 The Future of Work and Technology23:59 Leadership and AIConnect with Cynthia and Rich: • https://www.wellpay.ai/• https://www.linkedin.com/in/cynthiawellpay/• https://www.linkedin.com/in/datasciencedoc/ Connect with Raul: • Work with Raul: https://dogoodwork.io• Growth Resources: https://dogoodwork.io/resources• Connect with Raul on LinkedIn (DMs open): https://www.linkedin.com/in/dogoodwork/ 

 We're super excited to talk to a member of the bargaining committee for ZeniMax Workers United CWA about how they unionized and what they won in their recent tentative agreement with the company. This is an important step forward for the video game industry. We also talk to a union painter in Tennessee about the International Union of Painters and Allied Trades (IUPAT) ✦ ABOUT ✦The Valley Labor Report is the only union talk radio show in Alabama, elevating struggles for justice and fairness on the job, educating folks about how they can do the same, and bringing relevant news to workers in Alabama and beyond.Our single largest source of revenue *is our listeners* so your support really matters and helps us stay on the air!Make a one time donation or become a monthly donor on our website or patreon:TVLR.FMPatreon.com/thevalleylaborreportVisit our official website for more info on the show, membership, our sponsors, merch, and more: https://www.tvlr.fmFollow TVLR on Facebook: https://www.facebook.com/TheValleyLab...Follow TVLR on Twitter: @LaborReportersFollow Jacob on Twitter: @JacobM_ALFollow TVLR Co-Creator David Story on Twitter: @RadiclUnionist✦ CONTACT US ✦Our phone number is 844-899-TVLR (8857), call or text us live on air, or leave us a voicemail and we might play it during the show!✦ OUR ADVERTISERS KEEP US ON THE AIR! ✦Support them if you can.The attorneys at MAPLES, TUCKER, AND JACOB fight for working people. Let them represent you in your workplace injury claim. Mtandj.com; (855) 617-9333The MACHINISTS UNION represents workers in several industries including healthcare, the defense industry, woodworking, and more. iamaw44.org (256) 286-3704 / organize@iamaw44.orgDo you need good union laborers on your construction site, or do you want a union construction job? Reach out to the IRONWORKERS LOCAL 477. Ironworkers477.org  256-383-3334 (Jeb Miles) / local477@bellsouth.netThe NORTH ALABAMA DSA is looking for folks to work for a better North Alabama, fighting for liberty and justice for all. Contact / Join: DSANorthAlabama@gmail.comIBEW LOCAL 136 is a group of over 900 electricians and electrical workers providing our area with the finest workforce in the construction industry. You belong here. ibew136.org Contact: (205) 833-0909IFPTE - We are engineers, scientists, nonprofit employees, technicians, lawyers, and many other professions who have joined together to have a greater voice in our careers. With over 80,000 members spread across the U.S. and Canada, we invite you and your colleagues to consider the benefits of engaging in collective bargaining. IFPTE.org Contact: (202) 239-4880THE HUNTSVILLE INDUSTRIAL WORKERS OF THE WORLD is a union open to any and all working people. Call or email them today to begin organizing your workplace - wherever it is. On the Web: https://hsviww.org/ Contact: (256) 651-6707 / organize@hsviww.orgENERGY ALABAMA is accelerating Alabama's transition to sustainable energy. We are a nonprofit membership-based organization that has advocated for clean energy in Alabama since 2014. Our work is based on three pillars: education, advocacy, and technical assistance. Energy Alabama on the Web: https://alcse.org/ Contact: (256) 812-1431 / dtait@energyalabama.orgThe Retail, Wholesale and Department Store Union represents in a wide range of industries, including but not limited to retail, grocery stores, poultry processing, dairy processing, cereal processing, soda bottlers, bakeries, health care, hotels, manufacturing, public sector workers like crossing guards, sanitation, and highway workers, warehouses, building services,  and distribution. Learn more at RWDSU.infoThe American Federation of Government Employees (AFGE) is the largest federal employee union proudly representing 700,000 federal and D.C. government workers nationwide and overseas. Learn more at AFGE.orgAre you looking for a better future, a career that can have you set for life, and to be a part of something that's bigger than yourself?   Consider a skilled trades apprenticeship with the International Union of Painters and Allied Trades. Learn more at IUPAT.orgUnionly is a union-focused company created specifically to support organized labor. We believe that providing online payments should be simple, safe, and secure.  Visit https://unionly.io/ to learn more.Hometown Action envisions inclusive, revitalized, and sustainable communities built through multiracial working class organizing and leadership development at the local and state level to create opportunities for all people to thrive. Learn more at hometownaction.orgMembers of IBEW have some of the best wages and benefits in North Alabama. Find out more and join their team at ibew558.org ★ Support this podcast on Patreon ★

In this episode, the hosts of Command Control Power discuss their personal lives and tech experiences, including outdoor activities and everyday tech issues. They delve into a peculiar issue one encountered with a MacBook Pro during an update, which turned out to be related to Dell Display Manager. The conversation also covers Backblaze backup anomalies, Apple's migration assistant quirks, and problematic customer service interactions with vendors like Microsoft and RingCentral. To wrap up, the team reflects on the importance of considering user behavior in quality assurance for tech products and services. 00:00 Introduction and Catching Up 00:54 Unexpected MacBook Pro Issue 03:33 Dell Display Manager Mystery 05:27 Annoying Software Bugs 08:48 Client Troubleshooting Story 17:55 Apple Watch Repair Misunderstanding 23:48 Backblaze Exclusions and Concerns 25:13 MacBook Air Story and Backup Issues 26:32 Backblaze Deduplication and Support 28:15 Trust Issues with Backblaze 30:48 Considering Alternative Backup Solutions 33:53 Client Concerns and Backup Costs 41:48 RingCentral and Phone Services 49:39 Quality Assurance in Tech 52:18 Concluding Thoughts and Listener Invitation

In Episode 101 of the Construction Royalty Podcast, host Irvin is joined by his girlfriend Ewelina as they dive into Irvin's experiences in podcasting and real estate. They discuss the roots of his podcasting journey, his early interviews, and his transition to construction-focused content. Irvin shares insights into his current project—building a house in Edinburg, Texas—covering detailed steps like choosing land, blueprint development, and the construction process. They also touch on the importance of quality in building, market trends, and the challenges faced in real estate development. Join us for an insightful look into the world of construction and podcasting!    00:00 Nervous Beginnings and Client Rants 00:34 Introduction to the Podcast 01:15 First Podcast Experiences  04:49 Podcast Evolution and Guest Variety 06:05 Focusing on Construction 07:37 Memorable and Unreleased Episodes 09:19 Community Events and Future Plans  10:59 Starting a Construction Development 12:40 Building a House: Step-by-Step Process 17:37 Navigating Permits and Inspections 22:40 Inspection Process and Plumbing 23:26 Scheduling and Conducting Inspections 23:56 Rebar and Structural Details 25:04 Contractors and Quality Assurance 28:00 Cement Pouring and Weather Concerns 30:02 Framing and Roofing 32:44 Interior Work and Inspections 33:19 Challenges and Adjustments 36:41 Neighborhood Standards and Aesthetics 38:23 Future Plans in Real Estate 41:56 Final Thoughts and Wrap-Up   Follow Us! Website Follow Ewelina! Instagram