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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 [email protected]Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!
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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 [email protected]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.
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Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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 [email protected]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.
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Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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…
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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 [email protected]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.
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Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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, 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 [email protected]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 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 [email protected]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, 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 [email protected]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 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.
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Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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 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 [email protected]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 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 NotesIn 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 [email protected]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 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 [email protected]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, presented by Medvacon, hosts Joe Toscano and Mike Kent discuss strategies for fostering and embracing change, sharing insights from their extensive consultancy experience. They emphasize the importance of cultivating an environment where all employees feel comfortable presenting and implementing new ideas. Additionally, they explore how individuals can adapt to imposed changes by understanding the underlying benefits and maintaining a positive mindset. The episode also touches on the broader implications of change management and sets the stage for a follow-up discussion focused on change within regulated environments.
Contact MEDVACON:
Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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 by Medvacon, hosts Joe Toscano and Mike Kent continue their visit with Rhiannon Shadrick to delve deeper into Talent Acquisition. Building on insights from episode six, this discussion explores the critical roles of recruiters and candidates, the importance of an organized hiring process, company branding, and communication. The conversation also emphasizes the necessity of the right tools, such as an ATS and LinkedIn, and delves into current candidate market challenges. Practical advice is shared for both companies and job seekers to enhance the recruitment experience, foster long-term working relationships, and navigate a competitive job market successfully.
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Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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 presented by Medvacon, hosts Joe Toscano and Mike Kent are joined by senior recruiting specialist Rhiannon Shadrick to discuss the complexities of talent acquisition in the regulated life sciences industry. The conversation highlights key challenges such as inefficient hiring processes, the importance of first impressions and company branding, and balancing compensation and benefits packages. The trio offers practical advice for companies to enhance their recruitment strategies and maintain a competitive edge. Medvacon also provides details on how their services can assist organizations in various specialized areas.
Contact MEDVACON:
Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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, presented by MEDVACON, hosts Joe Toscano and Mike Kent continue their leadership discussion with guest Kristin Aikin Salada. Building on Episode 4, they further examine ways to overcome challenges of leading in regulated environments, the importance of effective delegation, and the benefits of mentorship programs. The conversation delves into the significance of leaders being curious and truly listening, as well as modeling vulnerability and authenticity. Listeners are provided with practical strategies to improve team performance and foster a culture of continuous growth and connection. The episode underscores the value of building resilience through relationships and the impact of leaders engaging with their teams at all levels.
Contact MEDVACON:
Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]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 presented by Medvacon, hosts Joe Toscano and Mike Kent are joined by leadership expert Kristin Aikin Salada. With over 20 years of experience, Kristin shares key leadership strategies applicable at all organizational levels. The discussion covers the importance of listening, taking initiative, understanding organizational culture, and utilizing personality assessments effectively. They also explore storytelling in leadership, asking questions to empower team members, and ensuring organizational alignment with company goals. Tune in for an in-depth look at how these leadership practices can be applied in regulated environments to enhance overall success.
00:00 Introduction to The Quality Grind Podcast00:25 Meet Leadership Expert Kristin Aikin Salada
01:21 The Importance of Leadership at All Levels
03:32 Effective Listening and Self-Interruption
05:16 Taking Initiative and Risks in Leadership
08:33 Understanding and Adapting to Organizational Culture
10:44 Using Personality Assessments for Better Leadership
20:14 Engaging with Your Team Creatively
23:51 Communicating Organizational Goals Effectively
27:44 The Power of Storytelling in Leadership
33:30 Conclusion and Key Takeaways
35:03 Outro and Contact Information
Contact MEDVACON:
Message us at @MedvaconLifeSciences on LinkedIn Visit our website at www.medvacon.com/contact Email us at [email protected]Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!
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