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/Â
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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 can learn purposefully. He also takes aim at those feel-good metrics, like celebrating zero deviations, that can hide unknowns rather than prove control.Â
 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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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 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,Â
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. Â
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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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 O'Donnell, Anders Vinther, Matt Pearson, Barry Byrne, and Rosanna Bules.
The Fearless Organisation and The Right Kind of Wrong by Amy Edmonson, Â
Turn the Ship Around by David Marquet. Â
Quality Risk Management: A Practical Guide by Jim Vesper & Amanda McFarland.Â
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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… 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 Greenehttps://prst.ie/wp-content/uploads/2020/11/Knowledge-as-the-Currency-of-Managing-Risk-Uniting-QRM-and-KM-28Oct20-FINAL-for-Level3.pdf
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.
Ireland