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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
40 episodes
The Power of Storytelling - Part 2
In part 2 of this Quality Grind Podcast episode, we continue our visit with Dr. Andrew Black about how storytelling can enhance knowledge transfer, engage teams, and simplify complex information in regulated life science environments. ...
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Season 1
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Episode 28
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34:57
QGP Short: Compounding Pharmacies - Regulatory Landscape and Requirements
Compounding Pharmacies – are you prepared for increased scrutiny?With select grace periods now behind us, FDA's focus has shifted to active enforcement. Inspections and warning letters are becoming more frequent as FDA hones in on...
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Season 2
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Episode 12
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4:21
QGP Short: Increased FDA Enforcement of Drug Advertising Requirements
The FDA is cracking down — hard — on misleading drug advertising across TV, social media, and digital platforms.Why? Too many ads are pushing benefits while burying risks — or skipping fair balance entirely. Influencer campaigns, compoun...
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Season 2
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Episode 11
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3:08
The Power of Storytelling - Part 1
Let me tell you a story... about a life sciences professional who used storytelling to improve knowledge transfer, create a sense of purpose, and enhance the overall performance of their teams.This isn't fiction. Storytelling is a tool t...
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Season 1
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Episode 27
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42:35
QGP Short: Responding to 483 Observations and Warning Letters
In this Quality Grind Short by Medvacon, learn how to handle FDA 483 observations and warning letters effectively. We will guide you through the key steps in responding, emphasizing the importance of addressing systemic root causes, improving p...
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Season 2
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Episode 10
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5:41
QGP Short: Improving Effectiveness of Annual GMP Training
Is your GMP training just the same old annual routine? Time to change things up!GMP training doesn’t have to be generic. And it certainly doesn’t have to be boring. But all too often, that’s exactly what it turns into. In this Quality Gr...
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Season 2
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Episode 9
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4:06
QGP Short: Managing Inspections and Audits
Let’s be honest. Inspections and audits can make even the most seasoned teams nervous. But in GMP environments, they’re not a surprise. They’re part of the job. The real question is… are you really ready when the knock comes?In ...
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Season 2
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Episode 8
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5:10
QGP Short: AI in GMP Environments - Risks and Regulatory Guidance
In pharmaceutical and biotech manufacturing, artificial intelligence is no longer a future concept. It’s here, supporting product development, process control, and quality decisions in GMP-regulated environments. But with this opportunity comes...
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Season 2
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Episode 7
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6:00
QGP Short: Agency Communication and Regulatory Surveillance
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 t...
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Season 2
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Episode 6
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3:35
Navigating Cell & Gene Therapy: The Quality Path to a Bright Future
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 qualit...
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Season 1
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Episode 26
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38:13
Navigating Cell & Gene Therapy: Cultivating Partnerships and Progress
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 devel...
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Season 1
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Episode 25
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28:37
Lean Principles and Regulated Life Sciences - Part 2
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, through...
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Season 1
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Episode 24
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41:40
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Navigating Cell & Gene Therapy: Accelerating Development and Innovation
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, h...
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Season 1
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Episode 23
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40:07
Navigating Cell & Gene Therapy: Setting the Stage for Success
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 fir...
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Season 1
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Episode 22
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23:49
Lean Principles and Regulated Life Sciences - Part 1
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, ...
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Season 1
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Episode 21
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25:55
Leadership Goes Both Ways: Coachability and 'Feed Forward'
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 embr...
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Season 2
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Episode 5
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4:47
Delegation as a Cure for Constrained Thinking
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 delega...
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Season 2
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Episode 4
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5:41
Applying Lean Principles to Controlled Documents - Part 2
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 ‘Le...
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Season 1
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Episode 20
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34:42
Applying Lean Principles to Controlled Documents - Part 1
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 strategie...
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Season 1
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Episode 19
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38:55
Entertaining Better Training, Part 2
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 importanc...
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Season 1
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Episode 18
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27:35
Entertaining Better Training, Part 1
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 t...
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Season 1
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Episode 17
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33:15
Quality Grind Short - Medical Devices: Get Ready for QMSR and ISO 13485
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) ...
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Season 2
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Episode 3
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5:34
Quality Grind Short - Talent Acquisition: Interview Strategies for Candidates
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 Follow...
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Season 2
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Episode 2
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4:46
Quality Grind Short - Training: New Approaches, More Impact
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 ...
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Season 2
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Episode 1
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5:38
Impact of Adopting ISO13485 in New QMSR for Medical Devices, Part 2
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 implica...
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Episode 16
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28:55
