Quality Grind Podcast

Send us Fan Mail In part 2 of this Quality Grind Podcast episode, we continue our visit with Dr. Andrew Black about how storytelling can enhance knowledge transfer, engage teams, and simplify complex information in regulated life science environments.  The episode features a practical example where Andy guides Mike in refining a story from his career, illustrating the five-element framework of sto...

Send us Fan Mail Compounding Pharmacies – are you prepared for increased scrutiny? With select grace periods now behind us, FDA's focus has shifted to active enforcement. Inspections and warning letters are becoming more frequent as FDA hones in on compliance with both agency registration requirements and USP compounding standards. Today's Quality Grind Short will help you strengthen you...

Send us Fan Mail The FDA is cracking down — hard — on misleading drug advertising across TV, social media, and digital platforms. Why? Too many ads are pushing benefits while burying risks — or skipping fair balance entirely. Influencer campaigns, compounded drug promos, and telehealth ads are under the microscope. As a result, we’ve seen hundreds of warning letters and cease-and-desist letters ha...

Send us Fan Mail Let me tell you a story... about a life sciences professional who used storytelling to improve knowledge transfer, create a sense of purpose, and enhance the overall performance of their teams. This isn't fiction. Storytelling is a tool that people have been using for thousands of years to convey important information. In this episode of the Quality Grind Podcast, Dr. Andy Bl...

Send us Fan Mail In this Quality Grind Short by Medvacon, learn how to handle FDA 483 observations and warning letters effectively. We will guide you through the key steps in responding, emphasizing the importance of addressing systemic root causes, improving processes, and maintaining transparent communication with the FDA. Discover strategies for crafting a thorough response that demonstrates ow...

Send us Fan Mail Is your GMP training just the same old annual routine? Time to change things up! GMP training doesn’t have to be generic. And it certainly doesn’t have to be boring. But all too often, that’s exactly what it turns into. In this Quality Grind Short, Mike describes a few easy-to-implement strategies that will shift your annual GMP training from something people have to do into somet...

Send us Fan Mail Let’s be honest. Inspections and audits can make even the most seasoned teams nervous. But in GMP environments, they’re not a surprise. They’re part of the job. The real question is… are you really ready when the knock comes? In this Quality Grind Short, Mike highlights proven strategies for effectively managing regulatory inspections and audits, including 4 industry best practice...

Send us Fan Mail In pharmaceutical and biotech manufacturing, artificial intelligence is no longer a future concept. It’s here, supporting product development, process control, and quality decisions in GMP-regulated environments. But with this opportunity comes significant responsibility. While AI offers powerful capabilities, it also introduces a new set of risks, ones that must be managed to mee...

Send us Fan Mail In this Quality Grind Short, Mike examines the latest trends in FDA agency communications, including the use of LinkedIn and other media to reach out to regulated life science companies. He then suggests ways that companies can stay on top of these communications without the need for a full-time Regulatory Surveillance team. Contact MEDVACON: Message us at @MedvaconLifeSciences on...

Send us Fan Mail In this episode of the Quality Grind Podcast, hosts Joe Toscano and Mike Kent conclude their four-part series on Cell and Gene Therapy with guest Ray Kaczmarek. They discuss the importance of building relationships and implementing solid quality systems across the development lifecycle.  Ray shares his pragmatic views on ensuring quality and compliance from early stages, the signi...

Send us Fan Mail Welcome to Part 3 of Medvacon’s 4-part series entitled “Navigating Cell & Gene Therapy”, where Joe and Mike continue their visit with industry leader Ray Kaczmarek. In this episode, the 3 dive deep into the significance of disciplined development, strong supply chains, and well-cultivated partnerships within the cell and gene therapy space. The conversation emphasizes the impo...

Send us Fan Mail Join host Mike Kent and special guest Jose Mora as they continue to explore the application of Lean principles within regulated life science environments. In this episode, they explore seven key benefits of Lean: quality and compliance, throughput and operating expense reduction, speed to market, flexibility and adaptability, continuous improvement, risk management, and customer f...

Send us Fan Mail Welcome back to the Grind, where Joe and Mike continue their exploration of Cell & Gene Therapy with expert Ray Kaczmarek. In this episode, part 2 of our 4-part series, Ray provides perspective on navigating the development process, highlighting some key factors for success – robust science, integrous data and stage-appropriate systems and structure. Learn strategies for selec...

Send us Fan Mail Welcome to The Grind! Hosts Joe Toscano and Mike Kent caught up with special guest Ray Kaczmarek in San Diego for an insightful discussion highlighting the complexities and dynamic nature of Cell and Gene Therapy. In this episode, the first in a 4-part series, Ray shares his experiences from military service to multiple C-suite roles during his 25-year career in both pharma and bi...

Send us Fan Mail In this episode of the Quality Grind Podcast, host Mike Kent welcomes Jose Mora back to discuss the application of Lean principles in regulated life science environments. Tune in as they dive deep into the importance and utility of Lean, with plenty of real-life stories from across product development and commercial manufacturing. Learn about situational awareness, visual signals,...

Send us Fan Mail In this Quality Grind Short, we delve into the concept of coachability and its critical role in organizational effectiveness and team success. We explore how individuals and teams can become more open to feedback, shift their behavior, and embrace a mindset geared towards learning and improvement. The episode highlights the importance of creating a culture of 'feed forward&ap...

Send us Fan Mail In this Quality Grind Short, we highlight an excerpt from Episode 5 of the Quality Grind Podcast with Kristin Aikin Salada on a specific leadership tactic with many beneficial outcomes - Delegation. Kristin describes the 3 modes of delegation, and uses her own experience with delegating to a junior team member to illustrate the benefits of this key strategy. To listen to the entir...

Send us Fan Mail In this episode of the Quality Grind Podcast, host Mike Kent and special guest Jose Mora continue exploring the application of Lean principles to controlled documents in regulated life sciences. Jose uses multiple examples to illustrate how ‘Lean’ works to optimize document effectiveness by creating a hierarchy where the 'why,' the 'what,' and the 'how to&...

Send us Fan Mail Welcome to the Quality Grind Podcast presented by Medvacon! Join Mike Kent and special guest Jose Mora as they dive deep into Lean principles and their application to controlled documents in regulated life science industries. Discover strategies to make documents more user-friendly and effective, and explore holistic approaches to optimizing workflows.  With over 30 years of exper...

Send us Fan Mail In this episode of the Quality Grind Podcast, host Mike Kent and special guest Ronnie Feldman continue to explore creative techniques for making compliance training engaging and effective, including storytelling, music, humor, and the importance of tailoring your approach for diverse audiences. Feldman shares insights on adopting a “train less, communicate more” strategy, using th...

Send us Fan Mail In this episode of the Quality Grind Podcast, host Mike Kent sits down with Ronnie Feldman, founder, CEO, and Creative Director of Learnings & Entertainments. Ronnie shares his unique journey from improvisational comedy at The Second City to transforming the effectiveness of compliance training through engaging and entertaining approaches. The conversation delves into the appl...

Send us Fan Mail Welcome back to The Grind! In this Short episode, we highlight the upcoming changes to 21 CFR 820, which governs medical devices in the U.S. Learn ways to assess your readiness to comply with the new Quality Management System Regulation (QMSR) and its alignment with the ISO 13485 standard. Contact MEDVACON: Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.m...

Send us Fan Mail In today’s Short, Rhiannon Shadrick provides some strategies for candidates to increase their chances of landing that next job opportunity, identifying some tips for each phase of the interview process – Preparation, the Conversation and Following Up. Get your pen and paper ready – you’ll want to take some notes… Contact MEDVACON: Message us at @MedvaconLifeSciences on LinkedIn Vi...

Send us Fan Mail In today’s Quality Grind Short, Mike Kent discusses some quick wins to make Training more effective and efficient for everyone involved. Improving effectiveness starts with reducing the amount of training, which provides a little more space to engage other people in the process and experiment with new ideas. These pointers aren’t just for Training professionals or those in QA – ev...

Send us Fan Mail In this episode of the Quality Grind Podcast, host Mike Kent continues his discussion with Medvacon consultant Armin Beck about the newly amended 21 CFR 820, Quality Management System Regulation for medical devices. The duo explores the implications of new FDA inspection techniques, the importance of thorough gap analyses for readiness, and the increased responsibility of executiv...