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  • The Power of Storytelling - Part 2
    2025/10/07

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    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.

    The episode features a practical example where Andy guides Mike in refining a story from his career, illustrating the five-element framework of storytelling. The conversation also touches on the use of storytelling in coaching, mentoring, and networking.

    Listen in to learn how to turn complex regulations into clear, memorable connection points.

    Connect with our guest! You can reach out to Andy through his website, www.andrewblackconsulting.com, or connect with him on LinkedIn (Andrew Black PhD).

    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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    35 分
  • QGP Short: Compounding Pharmacies - Regulatory Landscape and Requirements
    2025/10/06

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    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 compliance with both agency registration requirements and USP compounding standards.

    Today's Quality Grind Short will help you strengthen your operations, stay inspection-ready, and protect both your patients and your business.

    At Medvacon, our experienced team guides compounding pharmacies through compliance challenges, helping to avoid costly issues and build confidence in your quality systems.

    Don’t wait until the FDA is at your door. Call us today at 833-633-8226 or visit www.medvacon.com to make sure your operations are fully aligned with regulatory expectations.

    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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    4 分
  • QGP Short: Increased FDA Enforcement of Drug Advertising Requirements
    2025/09/23

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    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, compounded drug promos, and telehealth ads are under the microscope. As a result, we’ve seen hundreds of warning letters and cease-and-desist letters having already been issued.

    In this Quality Grind Short, Mike talks about ways to prevent your products from becoming the subject of unfounded claims or non-compliant communication of health benefits and risks.

    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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    3 分
  • The Power of Storytelling - Part 1
    2025/09/17

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    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 that people have been using for thousands of years to convey important information. In this episode of the Quality Grind Podcast, Dr. Andy Black shares his experience and expertise on how we can use stories in regulated life science environments to both foster connection and improve decision-making.

    And stay tuned for the exciting conclusion in Part 2 of our chat with Andy, here on The Grind!

    To connect with Andy, you can follow him on LinkedIn (Andrew Black PhD), or visit his website at www.andrewblackconsulting.com.

    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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    43 分
  • QGP Short: Responding to 483 Observations and Warning Letters
    2025/08/15

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    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 processes, and maintaining transparent communication with the FDA.

    Discover strategies for crafting a thorough response that demonstrates ownership and accountability, and learn how to turn compliance challenges into opportunities for strengthening your quality systems.

    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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    6 分
  • QGP Short: Improving Effectiveness of Annual GMP Training
    2025/08/11

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    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 Grind Short, Mike describes a few easy-to-implement strategies that will shift your annual GMP training from something people have to do into something they actually want to do. Learn how to improve engagement and have people lining up for more instead of chasing stragglers at the end of the year.

    At Medvacon, we help organizations like yours deliver targeted and impactful training. Reach out and let’s build a program that does more than just check a box before the current calendar year expires.

    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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    4 分
  • QGP Short: Managing Inspections and Audits
    2025/08/01

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    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 this Quality Grind Short, Mike highlights proven strategies for effectively managing regulatory inspections and audits, including 4 industry best practices for staying ready, 3 common pitfalls and how to avoid them, and 4 specific strategies for improving the quality and ease of interactions with the inspector or auditor.

    Ready to take your inspection readiness to the next level? Whether you need to fine-tune your process, close compliance gaps, or strengthen how your team shows up during audits, Medvacon is here to support you. With proven experience across regulated industries, we can help you turn inspections into opportunities.

    Give us a call at 1-833-633-8226 or visit www.medvacon.com to get started.

    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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    5 分
  • QGP Short: AI in GMP Environments - Risks and Regulatory Guidance
    2025/07/29

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    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 significant responsibility. While AI offers powerful capabilities, it also introduces a new set of risks, ones that must be managed to meet compliance, safety, and quality expectations.

    In this Quality Grind Short - Mike outlines both the risks and opportunities that AI provides, and highlights guidance being provided by global regulatory agencies.

    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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    6 分