Risk Revolution

By: Risk Revolution
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  • Summary

  • 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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Biological Sciences Economics Management Management & Leadership Science
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Episodes
  • 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 hr and 1 min
  • 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 mins
  • 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 mins
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