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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.

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• Message us at @MedvaconLifeSciences on LinkedIn
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• Email us at qualitygrind@medvacon.com

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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 medical device companies, including the expansion of FDA access to audit reports and Quality Management Review records, as well as potential new agency inspection and oversight tactics. The episode also highlights the importance of Risk Management under ISO 13485 and how organizations can adapt to these new requirements. Tune in to learn the steps your company can take to navigate these changes effectively.

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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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 communication between sponsors and contract partners, as well as fostering strong interdepartmental relationships. Tips for managing documentation and data are also highlighted to prevent pitfalls and ensure the creation of high-quality products. Perfect for anyone looking for actionable tips and expert advice!

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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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 criticizing past mistakes. Lisa shares practical tips and stories illustrating how coachability fosters team success and how influencing and managing up can enhance organizational effectiveness. The episode concludes with insights on developing leadership programs that incorporate these vital skills.

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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In this episode of The Quality Grind Podcast, host Mike Kent continues the Technology Transfer series with Kim Lim, as the two illuminate more strategies for achieving successful collaborations between sponsor and contract partner organizations. Key discussion points include assessing the true capabilities of potential contract partners, the importance of early-stage technical reviews, and why relying solely on a Quality audit can leave sponsors with a potential false sense of security. Learn how CDMOs can differentiate themselves and help accelerate the development process.

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 to daily updates on blogs and podcasts! @medvacon on all platforms!

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In this episode of the Quality Grind Podcast, host Mike Kent interviews Medvacon biotechnology consultant Kim Lim about the intricacies of Technology Transfer in regulated life science industries. With over 30 years of experience, Kim shares insights on the importance of communication, planning and engaging partners early in development. They discuss the significance and roles of internal departments such as Development, CMC, and Analytical Development. Emphasizing transparency and collaboration, both in-house and with contract organizations, they outline strategies for a successful technology transfer process that includes robust science, documented quality, and careful selection of CDMOs and CROs.

Visit our website at www.qualitygrindpodcast.com to access additional resources related to Technology Transfer that are mentioned in the episode.

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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In this episode of The Quality Grind Podcast presented by Medvacon, hosts Joe Toscano and Mike Kent continue to expand on Leadership in Life Sciences, this time from a collaborative perspective. Special guest Lisa Bourquin, an expert in Organizational Development and Talent Management, shares her professional journey and insights on how team members can proactively meet their leaders halfway. Together, they dive into the attributes of initiative and ownership, discussing how these qualities are essential for fostering a high-performing team. Stay tuned for Part Two, where we will cover coachability, managing up, and engaging others. If you want to enhance team performance and leadership in your organization, this episode is a must-listen!

Show Notes

In this episode of The Quality Grind Podcast, hosts Joe Toscano and Mike Kent delve into the nuances of leadership from a new perspective. Joined by guest expert Lisa Bourquin, they explore the idea of not just top-down leadership but the essential role individual team members play. The discussion focuses on the importance of team members taking the initiative and ownership to meet leaders halfway, enhancing overall team performance and creating a collaborative environment. Lisa shares her extensive experience in Organizational Development and offers practical insights on fostering an engaging team dynamic, even in challenging situations. The episode is rich in real-life examples, tools like the RACI chart, and actionable advice for both leaders and team members striving for high performance. Stay tuned for part two, where they will cover coachability, managing up, and engaging others.

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 to daily updates on blogs and podcasts! @medvacon on all platforms!

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In this special episode of The Quality Grind Podcast presented by MEDVACON, hosts Joe Toscano and Mike Kent describe MEDVACON's exciting collaboration with the Viewpoint Project with Dennis Quaid. Joe shares the journey of how MEDVACON was approached for this unique opportunity, the steps involved, and the anticipated outcome of this segment. Listen in as they discuss the importance of quality compliance in the life science industry, talent acquisition, and the significance of consumer safety. This episode offers an insightful behind-the-scenes look at the making of this educational program and the journey from initial contact to the upcoming production. Stay tuned for periodic updates and join us on this incredible ride!

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 to daily updates on blogs and podcasts! @medvacon on all platforms!