Épisodes

  • 31: EU GMP Chapter 1 Update: The quiet rewrite that may change QRM auditability.

    31: EU GMP Chapter 1 Update: The quiet rewrite that may change QRM auditability.
    Dec 31 2025
    In this episode, Lori and Val explore the proposed update to Chapter 1 of the EU GMPs - Eudralex Volume 4. The update solidifies formality in Quality Risk Management and is clear that it expects subjectivity to be minimized. Join us as we discuss what this means in reality and how moving these expectations from a guidance to an inspection standard might impact QRM implementation.

    SHOW NOTES:
    The proposed update to Chapter 1 of the EU GMPs
    https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-1_en#respond-to-the-consultation
    Article by Dr Emma Ranmarine on Drug Shortages
    https://www.pda.org/pda-letter-portal/home/full-article/drug-shortage-is-a-wicked-problem
    Article by Dr Marty Lipa on connecting QRM and KM:
    https://prst.ie/wp-content/uploads/2020/11/Knowledge-as-the-Currency-of-Managing-Risk-Uniting-QRM-and-KM-28Oct20-FINAL-for-Level3.pdf
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    37 min
  • 30: Utilizing AI to improve QRM

    30: Utilizing AI to improve QRM
    Dec 1 2025
    This month, we’re going to discuss Artificial Intelligence with Mike Salem. Mike is an expert in AI with over 15 years of experience. He has a background in mathematics and computer science and has worked in several industries, including defense, education, finance, and more. The design of this podcast is to take us from understanding some general terms and concepts to how this can be leveraged to improve our QRM programs and decision-making, all while keeping humans in the loop.

    Show Notes:

    1. Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
    2. Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
    3. The EU AI Act
    4. Learning how to write prompts (3-part video series) – search OpenAI Academy to get started for free
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    1 h et 12 min
  • 29: Stability Under Pressure

    29: Stability Under Pressure
    Oct 30 2025
    LIVE from the Q1 Scientific Conference in Co. Kildare, Ireland, Nuala and Val, alongside guests Declan Lowney and Dr. Mark Powell, unpack how the Life Science industry is evolving its approach to pharmaceutical and medical device or combination product stability. With faster product cycles, complex supply chains, and new science on degradation, we are asking - is your stability strategy ready for what’s next?

    Declan Lowney, Director of Stability Sciences in Analytical Development - Biologics within Johnson & Johnson Innovative Medicine R&D, provides technical leadership in stability science and enhanced expertise in stability-related ICH and Regulatory guidance. Declan joined J&J in 2006 and has supported the commercial approval of over 10 products. Before joining J&J, Declan has over 10 years’ experience in the pharmaceutical industry across a broad range of areas, including R&D, QC, QA, Regulatory Affairs, and Pharmacovigilance, and is also a QP.

    Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification.

    Link to the Q1 conference https://conference.q1scientific.com/

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    52 min
  • 28: Quality Theatre to Quality Science - Jeremiah Genest’s Playbook

    28: Quality Theatre to Quality Science - Jeremiah Genest’s Playbook
    Sep 30 2025
    Val sits down with Jeremiah Genest, Senior Director of QTR at Just Evotec Biologics, to discuss intelligent failure. Jeremiah argues that quality systems should be designed to fail predictably, so we can learn purposefully. He also takes aim at those feel-good metrics, like celebrating zero deviations, that can hide unknowns rather than prove control.

    It’s provocative, it’s practical, and…You might never look at a green dashboard the same way again.

    Show Notes:
    Jeremiah's blog 'Investigations of a Dog' - https://investigationsquality.com/

    Philosophy of Deming and the 14 principles of the System of Profound Knowledge - https://deming.org/

    former FDA investigator and DI expert, Peter Baker's blog - https://www.liveoakqa.com/blog-1

    Upcoming Q1 conference (with the LIVE EPISODE of the Podcast) - https://conference.q1scientific.com/
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    1 h et 2 min
  • 27: Risk Revolution Bookshelf: What We’re Reading (And Why It Matters)

    27: Risk Revolution Bookshelf: What We’re Reading (And Why It Matters)
    Aug 28 2025
    In this special Book Club edition of Risk Revolution, join Nuala, Lori & Val as they dive into three powerful books that are reshaping the way we think about leadership, culture, and decision-making in regulated industries.

    From David Marquet’s Turn the Ship Around to Amy Edmondson’s The Right Kind of Wrong and Vesper & McFarland's Quality Risk Management: A Practical Guide,
    the risk revolutionaries explore how trust, psychological safety, and letting go of outdated habits all contribute to better quality, stronger teams, and smarter risk-based decisions.

    Expect honesty, personal reflections, and a few surprises along the way.

    Links:
    A Google Talk featuring L. David Marquet on his insights from the book - https://www.youtube.com/watch?v=IzJL8zX3EVk&t=247s
    A YouTube Video featuring Amy Edmonson: https://www.youtube.com/watch?v=C2zFnHCWWfw
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    1 h et 1 min
  • 26: The 2025 Half-Time Huddle

    26: The 2025 Half-Time Huddle
    Jul 31 2025
    Nuala and Val look back at the previous episodes this year to highlight some of the most interesting interviews, topics, and revelations. Nuala and Val share key insights from Professor Kevin O'Donnell, Anders Vinther, Matt Pearson, Barry Byrne, and Rosanna Bules.

    The Fearless Organisation and The Right Kind of Wrong by Amy Edmonson,
    Turn the Ship Around by David Marquet.
    Quality Risk Management: A Practical Guide by Jim Vesper & Amanda McFarland.
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    42 min
  • 25: In an AI-powered pharma world, where does Knowledge Management really belong?

    25: In an AI-powered pharma world, where does Knowledge Management really belong?
    Jun 30 2025
    Val is back from the Knowledge Summit — energized, inspired, and asking the big question:
    In an AI-powered pharma world, where does Knowledge Management really belong?
    Is it Quality, L&D, Tech Ops… or somewhere in between?
    Tune in as the team unpacks where KM delivers the most value — and why it matters more than ever.

    This week's show notes:

    • Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1
      • https://www.bioprocessintl.com/regulatory-affairs/integrating-knowledge-management-into-qms-for-early-stage-companies-a-practical-approach-for-improved-business-performance-and-growth-part-1
    • Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 2
      • https://www.bioprocessintl.com/regulatory-affairs/integrating-knowledge-management-into-qms-for-early-stage-companies-a-practical-approach-for-improved-business-performance-and-growth-part-2
    • Knowledge as the Currency of Managing Risk: A Novel Framework to Unite Quality Risk Management and Knowledge Management by Marty Lipa, Kevin O'Donnell & Anne Greene
      • https://prst.ie/wp-content/uploads/2020/11/Knowledge-as-the-Currency-of-Managing-Risk-Uniting-QRM-and-KM-28Oct20-FINAL-for-Level3.pdf
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    41 min
  • 24: Decoding GMP Supplier Oversight by Applying QRM with Confidence

    24: Decoding GMP Supplier Oversight by Applying QRM with Confidence
    May 29 2025
    In this episode, we're decoding what effective GMP supplier oversight really looks like—and how sponsors can apply Quality Risk Management (QRM) principles to build smarter, more sustainable programs. We will cover supplier oversight, ongoing performance monitoring, and risk-based decision-making, with practical insights and a focus on what matters most: protecting product quality and patient safety.
    Whether you’re building a supplier oversight program from the ground up or refining what’s already in place, this episode delivers the tools and mindset shifts sponsors need to lead with intention and compliance.

    This month's guest is Rosanna Bules, a Certified Quality Auditor. Rosanna is a strategic and results-driven Quality Assurance Leader with 17+ years of biopharmaceutical experience (commercial and clinical), specializing in GMP Supplier Quality Management (SQM), audits, regulatory compliance, and risk-based quality oversight. Expertise in developing risk-based programs, conducting domestic and international audits, establishing and negotiating quality technical agreements (QTAs), and fostering cross-functional collaboration to ensure compliance with global regulations/guidelines. Proven track record in designing/developing processes, improving/streamlining existing processes, leading teams, and delivering measurable improvements in supplier oversight and management.

    This month’s show notes include:
    • Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1
    • Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 2
    • Link to FDA Chapter 56 Drug Quality Assurance: Outsourcing Facility Inspections
    • Link to Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
    • Link to FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
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    56 min
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