Episodios

  • 24: Decoding GMP Supplier Oversight by Applying QRM with Confidence

    24: Decoding GMP Supplier Oversight by Applying QRM with Confidence
    May 29 2025
    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
    • Link to Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
    • Link to FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
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    56 m
  • 23: From Battlefields to Biopharma: Knowledge Management in High-Risk Worlds

    23: From Battlefields to Biopharma: Knowledge Management in High-Risk Worlds
    Apr 30 2025
    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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    1 h y 3 m
  • 22: Role of Culture and Behaviors in Leading Hi-Performing Teams and Delivering Enhanced Performance

    22: Role of Culture and Behaviors in Leading Hi-Performing Teams and Delivering Enhanced Performance
    Mar 31 2025
    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:
    1. ISPE Cultural Excellence Report (2017) https://guidance-docs.ispe.org/doi/book/10.1002/9781946964618
    2. Carol Dweck Mindset book: https://www.amazon.com/Mindset-Psychology-Carol-S-Dweck/dp/0345472322
    3. Access Shane Craddock’s materials: https://shanecradock.com/
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    1 h y 1 m
  • 18: Quality Business Leadership

    18: Quality Business Leadership
    Feb 26 2025
    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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    54 m
  • 18: Happy Birthday QRM!

    18: Happy Birthday QRM!
    Jan 31 2025
    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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    44 m
  • 17: Risk Tolerance & Risk Acceptance

    17: Risk Tolerance & Risk Acceptance
    Jan 31 2025
    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.
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    49 m
  • 16: ICH Q9 Revision, Is it enough?

    16: ICH Q9 Revision, Is it enough?
    Jan 31 2025
    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.
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    58 m
  • 15: Foundations in Quality Risk Management w/Dr. Tim Sandle

    15: Foundations in Quality Risk Management w/Dr. Tim Sandle
    Jan 31 2025
    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
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    54 m
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