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Risk Revolution

Risk Revolution
Risk Revolution
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  • 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 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
    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
    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!
    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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  • 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 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 again by Risk Revolution co-hosts, Valerie Mulholland and Lori Richter with another old friend of the IVT network, Dr. James Vesper. Dr. Vesper will share his unique insights and deep learning on a very interesting aspect of RBDM, Risk Appetite, and the distinction between that and Risk Tolerance.  About Our Guest: James Vesper, MPH, Ph.D. established and is president of LearningPlus, Inc., and has had more than 30 years of experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. Since 1991, he and his firm, LearningPlus, have worked with pharma/biopharma, device, and blood products organizations around the world consulting on risk management, performance solutions, and custom GMP learning events. He has been a special advisor/consultant to the World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities working as a mentor and instructor for a number of different learning courses. Dr. Vesper has written five books, including Risk Assessment and Risk Management: Clear and Simple, and multiple technical articles. He has a BS in biology (Wheaton College), an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia. Dr. Vesper may be contacted at [email protected].
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About Risk Revolution

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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