Risk Revolution

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 f...

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...

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 revolutio...

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 Manage...

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 Ear...

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 s...

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 from Lebanon’s conflict zones to global pharma, revealing how real-time knowledge sharing can save lives, not just on the battlefield but also in medicine. They explore the transformative power of A...

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 continuously improve your processes by focusing on creating a culture, where mindsets, behaviors and employee engagement deliver real performance improvement for the business. Matt explains his views on achiev...

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, consistent product supply, and robust financial performance. Anders shares the Six Traits of a QBL. Anders also shares his thoughts on preserving quality as a company value and the role of engagement in deliver...

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 introduction to our listeners as he was the rapporteur for the ICH Q9(R1) update, chairs the PIC/s expert circle on QRM and is the Market Compliance Manager with the Irish Regulatory Agency the HPRA.   Pr...

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 industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. This week, series coordinator Nuala is joined once aga...

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 within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. In this episode, Stacey is joined by serie...

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 Sandle. One of the key topics of discussion is dealing with "Fuzzy Logic", and how to manage situations that appear vague, and how that applies to the Pharmaceutical and Healthcare industries. Welco...

This week, Stacey and Nuala sit down with Jayet Moon, author of "Foundations in Quality Risk Management" to review some of the key discussion points from his book and share his views on how risk management “is central to the science of prediction and decision-making;” and how “holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable.” ...

This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. 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 how they perceive and manage risk. Resources from this episode: Ris...

This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical, biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next. Resources from this episode: One Voice of Quality Website - https://prst.ie/1vq/ One-Voice-of-Quali...

In this week's edition of Risk Revolution, Stacey is joined by Nuala Calnan and Marty Lipa to discuss the Risk Knowledge Infinity Cycle. Stacey, Nuala, and Marty also chat about the ways Risk Management and Knowledge Management work together to provide a more effective Quality Management System and the two enablers to building an effective Quality Management System, QRM and KM, which really hav...

This week our series coordinators, Lori and Nuala, invite their guest Amanda McFarland to chat about Living the Risk Life. How do we take our colleagues on a journey from dreading their participation in the risk process to living a work-life and culture that embraces risk management? Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series a...

This week, Stacey welcomes back Nuala Calnan and Lori Richter for another episode in the Risk Revolution series. In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource. Resources in this episode: Humble Inquiry - The Gentle Ar...

This week, Stacey is joined by Nuala Calnan and Lori Richter to continue their series on Risk Revolution. Rob De La Espriella joins the show to share his insights and expertise on the need for critical thinking and complex problem-solving skills in getting to the root of the matter when we investigate, correct, and prevent failures. Resources from this episode: Root Cause Analysis – A Systema...

This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance how they perceive and manage risk. In this episode, our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging di...

This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance how they perceive and manage risk. This week our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging discussio...

This week our series coordinators, Lori and Nuala, will engage their guest Valerie Mulholland in a lively discussion on a critical aspect of Risk Management, namely the skills and confidence necessary to make effective and timely risk-based decisions. Articles: 1. Quality Risk Management: Seeking the Diamonds: Making the Case for Improved Formality in QRM Decision-making https://arrow.tudublin...

Welcome back to Risk Revolution, a monthly series of the 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 industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. In this episode, our Risk Revolution team, Lo...

Welcome to Risk Revolution, a monthly series of the 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 industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. On this episode, our Risk Revolution team, Lori Ri...

On this edition of the QRM Series Stacey, Lori, and Nuala are joined by Chris Flask. The team are going to take a look at risk management in the broader context and get some facts straight! De-risking your supply chain: http://www.ivtnetwork.com/sites/default/files/NUALA-IVT%20Network%20-%20De-risking%20Your%20Supply%20Chain.pdf Risk Assessment Steps for Success: http://www.ivtnetwork.com/sit...

The show will be launched soon.