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Risk Revolution

Risk Revolution

Auteur(s): Risk Revolution
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À propos de cet audio

 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
  • 30: Utilizing AI to improve QRM

    30: Utilizing AI to improve QRM
    Dec 1 2025
    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:

    1. Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
    2. Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
    3. The EU AI Act
    4. Learning how to write prompts (3-part video series) – search OpenAI Academy to get started for free
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    1 h et 12 min
  • 29: Stability Under Pressure

    29: Stability Under Pressure
    Oct 30 2025
    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/

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    52 min
  • 28: Quality Theatre to Quality Science - Jeremiah Genest’s Playbook

    28: Quality Theatre to Quality Science - Jeremiah Genest’s Playbook
    Sep 30 2025
    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/
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    1 h et 2 min
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