Risk Revolution
Risk Revolution
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About This Podcast
The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter.
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Recent Episodes
36: Can Annex 1 Deliver Better Risk Management?
More than a year after Annex 1 came into force, many organizations are still grappling with the challenge of turning contamination control strategies and risk assessments into meaningful operational…
35: 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…
34: 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…
33: 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…
32: 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…
31: 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…
30: 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…
29: 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…
28: 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…
27: Risk Revolution Bookshelf: What We’re Reading (And Why It Matters)
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…
26: The 2025 Half-Time Huddle
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…
25: In an AI-powered pharma world, where does Knowledge Management really belong?
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……
24: Decoding GMP Supplier Oversight by Applying QRM with Confidence
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…
23: From Battlefields to Biopharma: Knowledge Management in High-Risk Worlds
In this compelling Risk Revolution episode, Valerie Mulholland chats with Barry Byrne, Head of Knowledge Management Strategy at Novartis and a former Irish military officer. Barry shares his journey…
22: Role of Culture and Behaviors in Leading Hi-Performing Teams and Delivering Enhanced Performance
In this episode, Nuala Calnan chats with Matt Pearson, VP of Quality System & Risk Management at Guardant Health, about how to “switch on” your organisation to proactively manage risk and…
18: Quality Business Leadership
This month on Risk Revolution, Lori Richter chats with Anders Vinther, PhD, the Founder & CEO of Quality Business Administration (QBA). Lori and Anders discuss sustained product quality,…
18: Happy Birthday QRM!
The Risk Revolution Crew is back with an exciting celebratory podcast. Join Nuala, Val, and Lori as they reflect on 20 years of QRM with Prof Kevin O’Donnell. This week’s guest needs almost no…
17: Risk Tolerance & Risk Acceptance
Welcome to Risk Revolution, a monthly series of Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the…
16: ICH Q9 Revision, Is it enough?
Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices…
15: Foundations in Quality Risk Management w/Dr. Tim Sandle
In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the book "Foundations in Quality Risk Management" with the author, Dr. Tim…
Frequently Asked Questions
Risk Revolution has published 34 episodes since May 2022, covering topics in Business, Life Sciences.
Risk Revolution is currently highly active with new episodes monthly. Average episode length is 52m.
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