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Risk Revolution

Risk Revolution

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 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. Développement commercial et entrepreneuriat Entrepreneurship Gestion et leadership Science Sciences biologiques Économie
Épisodes
  • 26: The 2025 Half-Time Huddle

    26: The 2025 Half-Time Huddle
    Jul 31 2025
    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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    42 min
  • 25: In an AI-powered pharma world, where does Knowledge Management really belong?

    25: In an AI-powered pharma world, where does Knowledge Management really belong?
    Jun 30 2025
    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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    41 min
  • 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 min
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