Send us a text 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 storytelling. The conversation also touches on the use of storytelling in coaching, mentoring, an...

Send us a text 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 your operations, stay inspection-ready, and protect both your patients and your business. At Medvacon, our exper...

Send us a text 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 having already been issued. In this Quality Grind Short, Mike talks about ways to prevent your produc...

Send us a text 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 Black shares his experience and expertise on how we can use stories in regulated life science environments...

Send us a text 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 ownership and accountability, and learn how to turn compliance challenges into opportunities for stre...

Send us a text 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 something they actually want to do. Learn how to improve engagement and have people lining up for more i...

Send us a text 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 practices for staying ready, 3 common pitfalls and how to avoid them, and 4 specific strategies for improvi...

Send us a text 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 meet compliance, safety, and quality expectations. In this Quality Grind Short - Mike outlines both th...

Send us a text 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 LinkedIn Visit our website at www.medvacon.com/contact Email us at qualitygrind@medvacon.com Th...

Send us a text 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 significance of robust training programs, and the future prospects of the Cell and Gene Therapy fie...

Send us a text 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 importance of selecting the right partners and managing those relationships effectively to ensure busin...

Send us a text 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 focus. Learn how Lean can optimize Research & Development, enhance process validation, and impro...

Send us a text 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 selecting and working with manufacturing partners, the importance of defined technical roadmaps, and how...

Send us a text 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 biotech, emphasizing the importance of strong leadership, strategic planning, and team collaboration....

Send us a text 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, and how Lean processes can help you navigate challenges, improve quality, and optimize your workfl...

Send us a text 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' in leadership, which focuses on future success rather than past mistakes. Tune in for actionable tips and...

Send us a text 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 entire episode, or to hear more from Kristin and the Quality Grind Podcast, visit us at www.medvacon.com...

Send us a text 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' are easily identified and differentiated. The conversation then explores aligning Lean documentation with operational effic...

Send us a text 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 experience in manufacturing and quality systems, Jose shares his wealth of knowledge on minimizing ...

Send us a text 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 the fun thing to draw attention to the important thing, and building a better business case, all aime...