Risk Revolution

Auteur(s): Risk Revolution
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  • Résumé

  • 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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Développement commercial et entrepreneuriat Gestion et leadership Science Sciences biologiques Économie
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Épisodes
  • 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 min
  • 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 min
  • 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 min

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