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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 efficiency and audit readiness, underscoring the benefits of an engaged and informed workforce. Jose rounds out our visit by his sharing insights on starting the transformation journey, emphasizing cultural change, training, and involving the right people at the right time.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

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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 waste, improving efficiency, and optimizing effectiveness. Tune in to learn how Lean principles can transform your document management and operational practices.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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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 aimed at improving training outcomes and positively influencing compliance behavior in regulated environments.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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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 like 'Yes, and...', the importance of psychological safety, and the real-world impact of blending humor with serious topics to foster better learning outcomes in regulated life science industries. Tune in for part one of this insightful discussion and discover how creative solutions can reshape traditional training paradigms.

00:00 Introduction to The Quality Grind Podcast

00:48 Meet Ronnie Feldman: From Improv to Compliance Training

02:45 The Power of Humor in Corporate Education

07:38 Breaking Stereotypes in Training

22:47 The Importance of Psychological Safety

31:37 Conclusion and Teaser for Part Two

32:30 Medvacon Services and Contact Information

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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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 qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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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.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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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 participating in the training process.

How can you do that? Mike offers ways to discover creative options, anticipate challenges, and achieve better, data-driven outcomes.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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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 lens widens to discuss the potential impact on not just medical device firms but also the broader Life Sciences industry. The episode also offers practical guidance and resources to help organizations align with the new requirements and avoid regulatory pitfalls.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!