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Quality Grind Podcast
MEDVACON Life Sciences
26 episodes
17 hours ago
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...
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Life Sciences
Technology,
Science,
Chemistry
RSS
All content for Quality Grind Podcast is the property of MEDVACON Life Sciences and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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...
Show more...
Life Sciences
Technology,
Science,
Chemistry
Episodes (20/26)
Quality Grind Podcast
Lean Principles and Regulated Life Sciences - Part 1
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...
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21 hours ago
25 minutes

Quality Grind Podcast
Leadership Goes Both Ways: Coachability and 'Feed Forward'
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...
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1 week ago
4 minutes

Quality Grind Podcast
Delegation as a Cure for Constrained Thinking
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...
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2 weeks ago
5 minutes

Quality Grind Podcast
Applying Lean Principles to Controlled Documents - Part 2
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...
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2 months ago
34 minutes

Quality Grind Podcast
Applying Lean Principles to Controlled Documents - Part 1
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 ...
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2 months ago
38 minutes

Quality Grind Podcast
Entertaining Better Training, Part 2
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...
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2 months ago
27 minutes

Quality Grind Podcast
Entertaining Better Training, Part 1
Send us a text 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, a...
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2 months ago
33 minutes

Quality Grind Podcast
Quality Grind Short - Medical Devices: Get Ready for QMSR and ISO 13485
Send us a text 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 ...
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3 months ago
5 minutes

Quality Grind Podcast
Quality Grind Short - Talent Acquisition: Interview Strategies for Candidates
Send us a text 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 lis...
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3 months ago
4 minutes

Quality Grind Podcast
Quality Grind Short - Training: New Approaches, More Impact
Send us a text 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 off...
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4 months ago
5 minutes

Quality Grind Podcast
Impact of Adopting ISO13485 in New QMSR for Medical Devices, Part 2
Send us a text 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 medi...
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5 months ago
28 minutes

Quality Grind Podcast
Impact of Adopting ISO 13485 in New QMSR for Medical Devices, Part 1
Send us a text 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 ...
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5 months ago
27 minutes

Quality Grind Podcast
Technology Transfer Part 3: Executing the Transfer
Send us a text 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 wel...
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5 months ago
33 minutes

Quality Grind Podcast
Meeting Leaders Halfway - Part 2
Send us a text 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 illustrat...
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6 months ago
36 minutes

Quality Grind Podcast
Technology Transfer Part 2: Contract Partner Collaboration
Send us a text 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 ...
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6 months ago
24 minutes

Quality Grind Podcast
Technology Transfer Part 1: Preparing for Success
Send us a text 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...
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6 months ago
32 minutes

Quality Grind Podcast
Meeting Leaders Halfway - Part 1: Initiative and Ownership
Send us a text 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 th...
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6 months ago
40 minutes

Quality Grind Podcast
Viewpoint Project Journey Part 1
Send us a text 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 ...
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7 months ago
28 minutes

Quality Grind Podcast
Managing Change Part 1
Send us a text 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...
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8 months ago
34 minutes

Quality Grind Podcast
Talent Acquisition: Strategic and Tactical Insights, Part 2
Send us a text 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 int...
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9 months ago
27 minutes

Quality Grind Podcast
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...