Risk Revolution

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.

  1. MAY 1

    From Protocol to Performance: Applying QRM to Improve Clinical Trial Quality

    What does good risk management actually look like in clinical trials—and why are so many organizations still getting it wrong? In this episode of Risk Revolution, the team explores how the latest update to ICH E6(R3) is reshaping clinical trial design and execution, with a deeper focus on risk-based thinking, patient-centricity, and quality-by-design. Joined by clinical quality expert Joy Whitsett, the discussion moves beyond theory to examine how risk management is really being applied—and where gaps still exist. They cover:  Why risk management in clinical trials is often performed, but not truly integrated  The shift toward quality by design at the protocol level  How sponsors and CROs misalign on risk ownership and priorities  Why many risk assessments fail to focus on what actually matters: patient safety and meaningful data  The role of ICH E6(R3) in driving a more structured, risk-based approach   How patient experience and feasibility should shape trial design   Why over-reliance on templates, tools, and “check-the-box” processes can dilute real risk thinking   Practical ways to implement risk-based decision-making without adding complexity The key takeaway: effective risk management isn’t about doing more—it’s about focusing on what matters most, earlier in the process, and aligning teams around real-world outcomes. For professionals working across clinical, quality, and regulatory functions, this episode offers a clear look at how risk thinking is evolving—and what it takes to apply it in practice Link to ICH E8 R1Link to ICH E6R3 PDA Southeast Chapter QRM Practical Workshop Registration Link

    1h 10m

  2. MAR 31

    Is ICH Q9 Training a Reset for Risk Management?

    Is the new ICH Q9 training just more guidance—or a reset for how risk should be managed? In this episode, we break down the latest training materials and what they signal for Quality Risk Management (QRM) in practice. We cover:  Why this release feels like a shift in expectations—not just an update  The gap between risk tools and real decision-making  Challenges applying dense guidance in real-world settings   What organizations may need to rethink in existing QRM programs  If your team is focused on completing risk assessments rather than improving decisions, this episode will challenge your approach.

    58 min

  3. FEB 27

    Beyond ‘Human Error’- Designing for Humans

    In this episode of Risk Revolution, Val and Nuala are joined by Julie Avery and Dominic Furniss, both experts on Human Reliability, to tackle a stubborn challenge in pharmaceutical manufacturing quality: why we keep seeing repeat deviations, repeat CAPAs, and repeat “retraining’.    Julie and Dominic make a practical case for integrating Human Factors Engineering (HFE) into the PQS in a way that is not only cultural, but structured and auditable. Drawing lessons from other high-hazard industries (including COMAH), they outline what a pharma-focused human reliability guide could look like.   This conversation isn’t just theory. Julie and Dominic are actively building momentum, and they’re inviting quality leaders, practitioners, and learners to join a growing Community of Practice to share tools, case experiences, and practical ways to bring human reliability into real PQS work. If you’ve ever thought, ‘we keep fixing the symptom,’ this episode is for you.

    1h 3m

  4. JAN 30

    Risk Thinking: From Tools to Judgement

    In this episode, the hosts take a hard look at one of the most persistent challenges in modern quality risk management: why risk thinking feels natural in everyday life—but becomes so difficult at work. Moving beyond familiar tools like FMEA, heat maps, and scoring tables, the discussion explores what real risk thinking looks like in regulated environments—and why over-reliance on templates can sometimes suppress the very judgment and curiosity needed to manage risk effectively. Key topics include: Why completing a risk tool doesn’t necessarily mean risk has been managed The difference between risk analysis and risk-based decision-making How compliance pressure, audit defensibility, and organizational culture shape behavior What “good” risk-based decisions look like when information is incomplete Practical ways teams can talk about risk without pulling up a template The importance of humility, uncertainty, and learning from real-world outcomes The episode also connects today’s challenges to the evolution of ICH Q9 and the industry’s broader shift toward Quality Risk Management—asking whether the original intent has been lost along the way Show Notes: Risk management basics: what exactly is it? David Hillson Risk Doctor  Lori's upcoming PDA West Coast Chapter Event  Article: Steps Towards Demystifying Risk-Based Decision Making (Valerie Mulholland and Anne Greene  Valss Course on RBDM.... http://www.gmp.ie   Val’s 8 steps to better Risk Thinking in RBDM

    46 min

  5. 12/31/2025

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

    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

    37 min

  6. 12/01/2025

    Utilizing AI to improve QRM

    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: Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle  Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products  The EU AI Act  Learning how to write prompts (3-part video series) – search OpenAI Academy to get started for free

    1h 12m

  7. 10/30/2025

    Stability Under Pressure

    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/

    52 min

  8. 09/30/2025

    Quality Theatre to Quality Science - Jeremiah Genest’s Playbook

    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-1Upcoming Q1 conference (with the LIVE EPISODE of the Podcast) - https://conference.q1scientific.com/

    1h 2m
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About

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.

Information

  • Creator
    Risk Revolution
  • Years Active
    2022 - 2026
  • Episodes
    33
  • Rating
    Clean
  • Show Website
    Risk Revolution