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| Titre | Date | Durée | |
|---|---|---|---|
| 37: When Change Management Becomes the Risk | 05 Jul 2026 | 00:41:39 | |
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:
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 | |||
| 36: Can Annex 1 Deliver Better Risk Management? | 29 May 2026 | 00:42:41 | |
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. | |||
| 27: Risk Revolution Bookshelf: What We’re Reading (And Why It Matters) | 28 Aug 2025 | 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Risk Management: A Practical Guide, the risk revolutionaries explore how trust, psychological safety, and letting go of outdated habits all contribute to better quality, stronger teams, and smarter risk-based decisions.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 | |||
| 26: The 2025 Half-Time Huddle | 31 Jul 2025 | 00:42:10 | |
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. | |||
| 25: In an AI-powered pharma world, where does Knowledge Management really belong? | 30 Jun 2025 | 00:40:48 | |
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:
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| 24: Decoding GMP Supplier Oversight by Applying QRM with Confidence | 29 May 2025 | 00:55:47 | |
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:
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| 23: From Battlefields to Biopharma: Knowledge Management in High-Risk Worlds | 30 Apr 2025 | 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:
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| 22: Role of Culture and Behaviors in Leading Hi-Performing Teams and Delivering Enhanced Performance | 31 Mar 2025 | 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:
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| 18: Quality Business Leadership | 26 Feb 2025 | 00:54:17 | |
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/ | |||
| 18: Happy Birthday QRM! | 31 Jan 2025 | 00:43:42 | |
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 | |||
| 17: Risk Tolerance & Risk Acceptance | 31 Jan 2025 | 00:48:58 | |
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 jvesper@learningplus.com. | |||
| 16: ICH Q9 Revision, Is it enough? | 31 Jan 2025 | 00:58:13 | |
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 series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to be explored further. Resources from this episode: ICH Q9 Quality Risk Management Revision - https://www.ivtnetwork.com/article/ich-q9-quality-risk-management-revision Link to the new guidance - https://database.ich.org/sites/default/files/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf Understanding the Concept of Formality In Quality Risk ... - https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution - https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare? - https://www.ivtnetwork.com/article/can-%E2%80%98fuzzy-logic%E2%80%99-be-applied-risk-management-pharmaceuticals-and-healthcare-risk-revolution About Our Guest: Kate Coleman Kate has worked in Quality roles in the Pharma Industry up to the management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Doses. Kate is a practicing QP, Principal Consultant, qualified Lead Auditor, and an SME in Risk Management, New Facility Design/Start-Up, QC, and Sterility Assurance. | |||
| 35: From Protocol to Performance: Applying QRM to Improve Clinical Trial Quality | 01 May 2026 | 01:10:05 | |
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 update to ICH E6(R3) is reshaping clinical trial design and execution, with a deeper focus on risk-based thinking, patient-centricity, and quality-by-design. Joined by clinical quality expert Joy Whitsett, the discussion moves beyond theory to examine how risk management is really being applied—and where gaps still exist. They cover:
The key takeaway: effective risk management isn’t about doing more—it’s about focusing on what matters most, earlier in the process, and aligning teams around real-world outcomes. For professionals working across clinical, quality, and regulatory functions, this episode offers a clear look at how risk thinking is evolving—and what it takes to apply it in practice Link to ICH E8 R1 | |||
| 15: Foundations in Quality Risk Management w/Dr. Tim Sandle | 31 Jan 2025 | 00:53:35 | |
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. 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. Resources from this episode: The ICH Q9 (R1) Guidelines - https://www.dropbox.com/s/1xhsv2v0l2wumd2/ICH_Q9-R1_Documehttps:/www.dropbox.com/s/1xhsv2v0l2wumd2/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf?dl=0nt_Step2_Guideline_2021_1118.pdf?dl=0 ICH Q9 (R1) Presentation - https://www.dropbox.com/s/23loupxxij00pc3/Published%20ICH_Q9%28R1%29_Step_2_Presentation_2021_1126.pdf?dl=0 Can Fuzzy Logic Be Applied to Risk Management - https://www.ivtnetwork.com/article/can-%E2%80%98fuzzy-logic%E2%80%99-be-applied-risk-management-pharmaceuticals-and-healthcare Critical Thinking #1: Why Pharmaceuticals and Healthcare Needs - https://www.ivtnetwork.com/article/critical-thinking-1-why-pharmaceuticals-and-healthcare-needs-more-critical-thinkers Critical Thinking #2: Reading Research Papers - https://www.ivtnetwork.com/article/critical-thinking-2-reading-research-papers Critical Thinking #3: Developing Questions to Achieve the Optimal - https://www.ivtnetwork.com/article/critical-thinking-3-developing-questions-achieve-optimal-outcome Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution - https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution Risk Revolution - Getting to the Root of the Matter - http://www.ivtnetwork.com/article/getting-root-matter-risk-revolution-0 | |||
| 14: Foundations in Quality Risk Management | 31 Jan 2025 | 00:44:55 | |
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.” Jayet will also explain how lobsters can live forever. Resources from this episode: A Quantitative Method for Modelling http://www.ivtnetwork.com/sites/default/files/A%20Quantitative%20Method%20for%20Modelling%20COV...pdf Copy of SAQI eQE Newsletter Issue 241 - February 2021 http://www.ivtnetwork.com/sites/default/files/Copy%20of%20SAQI%20eQE%20Newsletter%20Issue%20241%20-%20February%202021.pdf Copy of Quality World - Spring 2021 http://www.ivtnetwork.com/sites/default/files/Copy%20of%20Quality%20World%20-%20Spring%202021.pdf Foundations Of Quality Risk Management: A Practical Approach to Effective Risk-Based Thinking https://asq.org/quality-press/display-item?item=H1578 About our guest: Jayet Moon Jayet has earned a master’s degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). Jayet is also a Chartered Quality Professional in the UK certified by the Chartered Quality Institute (CQI). He is also an Enterprise Risk Management Certified Professional (ERMCP) and a Risk Management Society (RIMS) certified Risk Management Professional (RIMS-CRMP). Jayet was recently awarded the Australian Organization for Quality 'Passion for Excellence' Award and recognized as the American Society for Quality '40 under 40' Rising Star in their November 2021 issue of Quality Progress magazine. He is a Fellow of the Royal Society for Arts (FRSA) and a Fellow of the International Institute for Safety and Risk Management (FIIRSM). He is the author of the book, ‘Foundations of Quality Risk Management’ published by ASQ Quality Press, and holds ASQ CQE, CQSP, and CQIA certifications. Popular articles authored by him on Quality and Risk Management have been published in global trade magazines such as Quality Press (USA), Quality World (UK), Quality Business (Australia and New Zealand), QCI Magazine (India), and eQuality Edge (South Africa). | |||
| 13: What's hot in QRM | 31 Jan 2025 | 00:44:43 | |
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: Risk-Based Decision Making: PODCAST RECORDING https://www.ivtnetwork.com/article/risk-based-decision-making-podcast-recording Risk Management, Knowledge Management, and the Risk https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution Understanding the Concept of Formality In Quality Risk ... https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management Quality Management Maturity – A Pilot Program of the FDA https://www.ivtnetwork.com/article/quality-management-maturity-%E2%80%93-pilot-program-fda ICH Q9 R1 concept document https://database.ich.org/sites/default/files/Q9-R1_Concept%20Paper_2020_1113.pdf ICH Q14 Concept Paper https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf 2021 Updated PIC/s Aide Memoire on Assessment of QRM Implementation https://picscheme.org/docview/3823 Sept 24 2021 Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-notices/gc-1220-pre-post-20210924.pdf QRM: a Case for Convergence: https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1160&context=level3 About Our Guest: Valerie Mulholland Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality Risk Management and is researching the topic of Risk-Based Decision Making for a Ph.D. dissertation with the Pharmaceutical Regulatory Science Team in TU Dublin. | |||
| 12: Disrupting the Paradigm | 31 Jan 2025 | 00:58:28 | |
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-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT - https://www.ivtnetwork.com/article/one-voice-quality-1vq-solutions-part-2-podcast-episode One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ... - https://www.ivtnetwork.com/article/one-voice-quality-1vq-solutions-%E2%80%93-enhanced-science-and-risk-based-approach-post-approval-cha Elon Musk Hiring Ad - https://www.cnbc.com/2020/02/03/elon-musk-is-recruiting-for-tesla-education-is-irrelevant.html What Is Industry 4.0? - https://www.youtube.com/watch?v=yKPrJJSv94M&t=1s ISPE Pharma 4.0 initiative - https://ispe.org/initiatives/pharma-4.0 About Our Guest: Karen Ginsbury Karen is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and bringing her unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics. | |||
| 11: To Infinity and Beyond | 31 Jan 2025 | 00:55:13 | |
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 have been kept separate in the industry but should be working together. Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. Resources from this episode: ISPE’s KM Good Practice Guide T.U. Dublin’s: A Survey Report on the Current State of QRM and KM Integration Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge Management Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers Effective Knowledge Transfer During Biopharmaceutical Technology Transfer Turning Knowledge Into an Asset in Pharmaceuticals – PODCAST About Our Guest: Marty Lipa Marty Lipa is the Executive Director - Knowledge Management at Merck. Marty has over 27 years in the biopharmaceutical industry and has led the KM Center of Excellence for Merck manufacturing for the last 11 years. Marty has recently completed the requirements for his Ph.D. at TU Dublin, emphasizing KM and its connection to QRM. | |||
| 10: From Dreading the Risk Process to Living the Risk Life | 31 Jan 2025 | 00:58:33 | |
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 aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk. Resources from this episode: 12 Inclusive Behaviors - The Kaleel Jamison Consulting - https://kjcg.com/s/12InclusiveBehaviors_AR_01202015.pdf How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis - https://www.pharmaceuticalonline.com/doc/how-to-become-a-better-facilitator-for-risk-assessment-and-root-cause-analysis-0001 Amy Edmondson – TED TALK, Psychological Safety - https://www.youtube.com/watch?v=eP6guvRt0U0 About Our Guest: Amanda McFarland - Senior Consultant at Valsource Amanda assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. Amanda specializes in creating and implementing risk management training programs, developing custom risk-based strategies, and risk facilitation. | |||
| 9: Facilitator - Friend or Foe? | 31 Jan 2025 | 00:59:08 | |
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 Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein The Surprising Power of Questions HBR Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT Bias, Heuristics & Risk (Pt. 2) on Risk Revolution | IVT About Our Speakers Lori Richter Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx, she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada, and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a Ph.D. at Technological University Dublin. Nuala Calnan – Nuala is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author, and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), and HPRA(Ireland) patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance, and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads several patient-focused regulatory science research projects at the Masters and Ph.D. levels. Tiff Baker – Tiff Baker, is a Senior Consultant at Valsource. Tiff has been working full-time in the QRM space for over ten years, and in micro roles within the industry before that. She has implemented QRM programs for companies internationally, delivered risk training to industry and regulators alike, developed custom risk tools to meet client needs, and facilitated many risk assessments over the years. She is a co-lead for the Parenteral Drug Association’s Remote Audits and Inspections Task Force as well as an instructor for the PDA Training and Research Institute. In addition, Tiff contributed as an author to ISPE’s Baseline Guide 5 for Commissioning and Qualification to incorporate risk as well as several Points to Consider documents for the PDA. | |||
| 8: Getting to the Root of the Matter | 31 Jan 2025 | 01:16:42 | |
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 Systematic Approach, JVT Article https://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systematic-approach Addressing the Root Cause, Not the Symptoms: Root Cause Investigations for CAPA – Podcast - https://www.ivtnetwork.com/article/addressing-root-cause-not-symptoms-root-cause-investigations-capa Getting to the Root of the Cause – BioPharm International article - http://www.ivtnetwork.com/sites/default/files/PRE PUB__BP0521_Getting to the root of the matter.pdf Rob De La Espriella is a former nuclear submarine officer and the founder/owner of DLE Technical Services, LLC (DLE), and DLE has been a prime contractor for the Department of Energy since 2012. Rob is one of the leading experts in causal analysis, with over 30 years of experience in leading and facilitating root cause analyses, event investigations, and assessments at commercial nuclear power plants, the US Nuclear Regulatory Commission (NRC), the DOE, the US Department of Defense (DOD), and Engineering firms. | |||
| 7: Bias and Heuristics Pt 2 | 31 Jan 2025 | 00:39:08 | |
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 discussion on how bias and heuristics impact risk management, risk identification, and the decisions made during the process. Resources from this episode: ICHQ9 on Quality Risk Management https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part I—The Role of Human Heuristics https://www.ivtnetwork.com/article/strategies-addressing-problems-subjectivity-and-uncertainty-quality-risk-management-exercise Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part II: Risk Communication and Perception Issues https://www.ivtnetwork.com/article/strategies-addressing-problems-subjectivity-and-uncertainty-quality-risk-management-exerci-0 | |||
| 6: Bias and Heuristics Pt 1 | 31 Jan 2025 | 00:37:57 | |
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 discussion on how bias and heuristics impact risk management, risk identification, and the decisions made during the process. Resources from this Episode: Understanding Problems of Subjectivity and Uncertainty in Quality Risk Management - https://www.ivtnetwork.com/article/understanding-problems-subjectivity-and-uncertainty-quality-risk-management Risk Analysis and Ordinal Risk Rating Scales A Closer Look - https://www.ivtnetwork.com/article/risk-analysis-and-ordinal-risk-rating-scales%E2%80%94-closer-look | |||
| 34: Is ICH Q9 Training a Reset for Risk Management? | 31 Mar 2026 | 00:58:06 | |
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 (QRM) in practice. We cover:
If your team is focused on completing risk assessments rather than improving decisions, this episode will challenge your approach. | |||
| 5: Confident Risk Management | 31 Jan 2025 | 00:48:35 | |
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.ie/level3/ 2. Role of Senior Leadership in Quality Risk Management | IVT - Risk - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management 3. Understanding the Concept of Formality In Quality Risk Management http://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management-0 Other Resources: 1. ISO 31010 – Risk Management - https://www.iso.org/iso-31000-risk-management.html 2. ICH Q9. Risk-Based Decisions We first encounter it in the Introduction to the guideline: “Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks, and can beneficially affect the extent and level of direct regulatory oversight.” And specifically, “…some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.” | |||
| 4: Becoming Risk Curious | 31 Jan 2025 | 00:47:23 | |
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, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around the risk curious concept and expand into the why’s and why not and the views of this practice under PICs. The group also reviews the need for training and development around risk, formalization of a risk management process, a top-down approach to building culture, and the need for critical thinking and risk-based decision-making. Links to Risk Revolution Takeaways: The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693 Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160 PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148 | |||
| 3: Defining Risk Culture | 31 Jan 2025 | 00:33:50 | |
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 Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, cover some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from her time as an agent at MHRA. Links to Risk Revolution Takeaways: The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693 Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160 PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148 | |||
| 2: Back to Basics | 31 Jan 2025 | 00:46:06 | |
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/sites/default/files/NUALA-Risk Assessment Steps for Success_PRST@TUDublin and BioPharmChem Ireland.pdf | |||
| 1: Stay Tuned | 11 May 2022 | 00:00:26 | |
The show will be launched soon. | |||
| 33: Beyond ‘Human Error’- Designing for Humans | 27 Feb 2026 | 01:03:15 | |
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 quality: why we keep seeing repeat deviations, repeat CAPAs, and repeat “retraining’. Julie and Dominic make a practical case for integrating Human Factors Engineering (HFE) into the PQS in a way that is not only cultural, but structured and auditable. Drawing lessons from other high-hazard industries (including COMAH), they outline what a pharma-focused human reliability guide could look like. This conversation isn’t just theory. Julie and Dominic are actively building momentum, and they’re inviting quality leaders, practitioners, and learners to join a growing Community of Practice to share tools, case experiences, and practical ways to bring human reliability into real PQS work. If you’ve ever thought, ‘we keep fixing the symptom,’ this episode is for you. | |||
| 32: Risk Thinking: From Tools to Judgement | 30 Jan 2026 | 00:45:43 | |
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 work. Moving beyond familiar tools like FMEA, heat maps, and scoring tables, the discussion explores what real risk thinking looks like in regulated environments—and why over-reliance on templates can sometimes suppress the very judgment and curiosity needed to manage risk effectively. Key topics include:
The episode also connects today’s challenges to the evolution of ICH Q9 and the industry’s broader shift toward Quality Risk Management—asking whether the original intent has been lost along the way Show Notes:
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| 31: EU GMP Chapter 1 Update: The quiet rewrite that may change QRM auditability. | 31 Dec 2025 | 00:37:11 | |
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 subjectivity to be minimized. Join us as we discuss what this means in reality and how moving these expectations from a guidance to an inspection standard might impact QRM implementation. SHOW NOTES: The proposed update to Chapter 1 of the EU GMPs https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-1_en#respond-to-the-consultation Article by Dr Emma Ranmarine on Drug Shortages https://www.pda.org/pda-letter-portal/home/full-article/drug-shortage-is-a-wicked-problem Article by Dr Marty Lipa on connecting QRM and KM: https://prst.ie/wp-content/uploads/2020/11/Knowledge-as-the-Currency-of-Managing-Risk-Uniting-QRM-and-KM-28Oct20-FINAL-for-Level3.pdf | |||
| 30: Utilizing AI to improve QRM | 01 Dec 2025 | 01:11:56 | |
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 worked in several industries, including defense, education, finance, and more. The design of this podcast is to take us from understanding some general terms and concepts to how this can be leveraged to improve our QRM programs and decision-making, all while keeping humans in the loop. Show Notes:
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| 29: Stability Under Pressure | 30 Oct 2025 | 00:52:21 | |
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/ | |||
| 28: Quality Theatre to Quality Science - Jeremiah Genest’s Playbook | 30 Sep 2025 | 01:02:11 | |
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 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/ | |||
| 38: The Books Every Risk Leader Should Read | 31 Jul 2026 | 01:03:48 | |
Some of the most valuable lessons in risk management don't come from regulations or templates. They come from books that challenge how we think, make decisions, communicate, and lead. In this special Book Club edition of Risk Revolution, hosts Nuala Calnan, Valerie Mulholland, and Lori Richter share the books that have most influenced their thinking about quality risk management, decision making, organizational culture, and leadership. They discuss practical lessons from Thinking, Fast and Slow, Upstream, Surrounded by Idiots, The Talent Code, and Deciding, while exploring how these ideas can improve risk assessments, strengthen decision making, and build more effective organizations. The episode also features Celeste Theberge of Takeda, who shares how her company's "Risky Reads" book club is helping develop quality risk management capability across the organization. They cover:
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