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Risk Revolution

Risk Revolution

Written by: Risk Revolution
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 Welcome to Risk Revolution! The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.

The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter. Biological Sciences Economics Management Management & Leadership Science
Episodes
  • 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 mins
  • 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 hr and 12 mins
  • 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 mins
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