Quality Grind Podcast
Welcome to The Quality Grind Podcast, presented by Medvacon! Join hosts Joe Toscano, President of Medvacon, and Mike Kent, Director of Learning Platforms, as they (we) have some fun while tackling topics related to the “everyday grind” within Life Science industries. Featuring conversations with key industry players, they’ll dive into their unique problem-solving strategies, career paths and personal interests. Most importantly, their (our) goal is to cultivate a community where information and experiences can be shared with and for the benefit of all, emphasizing the diversity of approaches to industry challenges and the importance of continuous engagement and learning.
Episodes
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...
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, an...
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 ...
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 Resea...
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 part...
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 st...
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 na...
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 fu...
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 ...
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 differ...
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 syst...
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 i...
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 application of improvisational principles l...
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.medvacon.com/contact
- Email us at qu...
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
- Visit our website at www.medvacon.co...
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 – everyone benefits from actively particip...
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 executive management in quality oversight. The...
In this episode of the Quality Grind Podcast, presented by Medvacon, Mike Kent welcomes Armin Beck, a consultant in the medical device field, to discuss FDA's recent adoption of ISO 13485 as part of its amended Quality Management System Regulation. This change, effective February 2, 2026, reinforces the FDA’s focus on harmonizing US regulations with global standards. The conversation covers the implications for m...
In this episode of the Quality Grind Podcast, host Mike Kent and Medvacon consultant Kim Lim round out their exploration of Technology Transfer, identifying the critical strategies that foster a smooth execution process. Discover the value of thorough preparation, the significance of quality agreements, and the role of process performance qualifications (PPQ). Emphasis is placed on maintaining transparent and frequent...
In this episode of The Quality Grind Podcast, hosted by Joe Toscano and Mike Kent from Medvacon, we continue our exploration of Leadership with special guest Lisa Bourquin. Continuing from the foundations laid in Episode 10 about initiative and ownership, they explore the significance of being open to feedback and a more effective 'feed forward' approach, which focuses on guiding improvement rather than crit...
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