Risk Revolution – Détails, épisodes et analyse

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Risk Revolution

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Fréquence : 1 épisode/44j. Total Éps: 36

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.

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37: When Change Management Becomes the Risk

Épisode 37

dimanche 5 juillet 2026 • Durée 41:39

Change management is intended to reduce risk—but what happens when the process itself becomes the biggest obstacle to improvement?

In this episode of Risk Revolution, Nuala Calnan is joined by Paddy Costello, Senior Director at Lachman Consultant Services, to explore how overly complex change management systems, aging facilities, and ineffective risk oversight can quietly increase risk instead of controlling it. Drawing on experience as both a regulator and industry leader, Paddy shares practical insights into why organizations struggle to implement meaningful change, how leadership teams can better understand their most significant operational risks, and why risk management must move beyond documentation to support better decision-making.

They cover:

Why overly complex change management systems often discourage meaningful improvement
The hidden risks of aging facilities, obsolete equipment, and deferred capital investments
Why rejected changes should be documented—not simply forgotten
How hazard registers can become more effective than traditional risk registers
The importance of Gemba walks in identifying risks that metrics and dashboards often miss
How quality culture influences risk management, change management, and leadership decision-making
Why senior leaders need greater visibility into their organization's most significant risks
Practical ways to simplify risk management while improving product quality, compliance, and patient safety

Show Notes:
PIC/s Document https://picscheme.org/docview/4294
Change Management/Change Control (Enabler or Blocker?) Part 1 of 2
Change Management and ICH Q12 - Part 2 of 2 - Lachman Consultants

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36: Can Annex 1 Deliver Better Risk Management?

Épisode 36

vendredi 29 mai 2026 • Durée 42:41

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 practice. Recorded live at the ISPE Ireland Affiliate INSPIRE event in Cork, Nuala Calnan and Valerie Mulholland are joined by Richard Denk to discuss the current state of Annex 1 implementation, the gaps regulators continue to identify, and why the future lies in designing risks out rather than documenting them away. Along the way, they explore contamination control strategies, operator involvement in risk assessments, automation, robotics, and the evidence needed to demonstrate that risk controls are truly effective.

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27: Risk Revolution Bookshelf: What We’re Reading (And Why It Matters)

Épisode 27

jeudi 28 août 2025 • Durée 01:01:03

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 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.

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

Épisode 26

jeudi 31 juillet 2025 • Durée 42:10

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 Management: A Practical Guide by Jim Vesper & Amanda McFarland.

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25: In an AI-powered pharma world, where does Knowledge Management really belong?

Épisode 25

lundi 30 juin 2025 • Durée 40:48

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 Greene
- 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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24: Decoding GMP Supplier Oversight by Applying QRM with Confidence

Épisode 24

jeudi 29 mai 2025 • Durée 55:47

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 safety.
Whether you’re building a supplier oversight program from the ground up or refining what’s already in place, this episode delivers the tools and mindset shifts sponsors need to lead with intention and compliance.

This month's guest is Rosanna Bules, a Certified Quality Auditor. Rosanna is a strategic and results-driven Quality Assurance Leader with 17+ years of biopharmaceutical experience (commercial and clinical), specializing in GMP Supplier Quality Management (SQM), audits, regulatory compliance, and risk-based quality oversight. Expertise in developing risk-based programs, conducting domestic and international audits, establishing and negotiating quality technical agreements (QTAs), and fostering cross-functional collaboration to ensure compliance with global regulations/guidelines. Proven track record in designing/developing processes, improving/streamlining existing processes, leading teams, and delivering measurable improvements in supplier oversight and management.

This month’s show notes include:

Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 1
Link to Integrating Knowledge Management into QMS for Early Stage Companies: A Practical Approach for Improved Business Performance and Growth, Part 2
Link to FDA Chapter 56 Drug Quality Assurance: Outsourcing Facility Inspections

23: From Battlefields to Biopharma: Knowledge Management in High-Risk Worlds

Épisode 23

mercredi 30 avril 2025 • Durée 01:02:36

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 AI, storytelling, and sense-making in regulated environments, and what pharma can learn from NASA, the military, and consulting giants—a must-listen for leaders driving cultural and knowledge change in high-stakes industries.

This month’s show notes include:

Links to the knowledge summit https://www.knowledgesummitdublin.com/
Links to David Snowdon’s Cynefin website https://thecynefin.co/
The Work of the PRST – Marty Lipa & Paige Kaine https://prst.ie/
TED TALK by the author of Turn the Ship Around, David Marquet https://www.youtube.com/watch?v=HYXH2XUfhfo
BOOK: Turn the Ship around: Turn the Ship Around!: A True Story of Turning Followers into Leaders by David Marquet (Author), Stephen R. Covey (Foreword – 7 habits of Highly Effective People)
BOOK: A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry (Biotechnology and Bioprocessing by Nuala Calnan, Marty Lipa, Paige Kane and Jose Menezes
BOOK: The Checklist Manifesto by Atul Gawande
What is Leadership: with David Marquet
David Marquet, Former-Captain, US Navy Seals: Turn The Ship Around!

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22: Role of Culture and Behaviors in Leading Hi-Performing Teams and Delivering Enhanced Performance

Épisode 22

lundi 31 mars 2025 • Durée 01:00:58

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 achieving a quality culture, how to strive for workplace engagement, how an organization's structure can lead to fractures, and the three critical enablers for anyone planning to implement sustainable culture change within their organization.

SHOW NOTES:

ISPE Cultural Excellence Report (2017) https://guidance-docs.ispe.org/doi/book/10.1002/9781946964618
Carol Dweck Mindset book: https://www.amazon.com/Mindset-Psychology-Carol-S-Dweck/dp/0345472322
Access Shane Craddock’s materials: https://shanecradock.com/

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18: Quality Business Leadership

Épisode 18

mercredi 26 février 2025 • Durée 54:17

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 delivering this competitive business advantage.

This month’s show notes include:

Learn more about the QBA program: https://qbaleaders.com/

QBA program feedback from participants: https://qbaleaders.com/qbl-program-feedback/

Want to apply to be in a cohort? https://qbaleaders.com/certification-program-application-form/

Taking a Stand for Pharmaceutical Quality: The Rise of the Quality Business Leader

Deming Institute: https://deming.org/the-deming-philosophy/

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18: Happy Birthday QRM!

Épisode 18

vendredi 31 janvier 2025 • Durée 43:42

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. Prof O’Donnell shares his reflections on the QRM journey and what is to come.

Listeners should note that Prof O’Donnell’s views are his own and do not necessarily reflect those of the agencies and organizations referenced above.

Show Notes

ICH Q9(R1) and the supporting training materials can be accessed here:

https://www.ich.org/page/quality-guidelines

The EMA recommendations draw on lessons learned from the presence of nitrosamines in sartan medicines

https://www.ema.europa.eu/en/news/european-regulators-make-recommendations-drawing-lessons-learnt-presence-nitrosamines-sartan-medicines

Technical Report No. TR 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages

https://www.pda.org/bookstore/product-detail/7852-technical-report-no-68

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