• 13: What's hot in QRM?

  • Nov 13 2022
  • Length: 43 mins
  • Podcast

13: What's hot in QRM?

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  • Summary

  • This episode was originally aired October 19th, 2021

    This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. 

    Resources from this episode:
    Risk-Based Decision Making: PODCAST RECORDING
    https://www.ivtnetwork.com/article/risk-based-decision-making-podcast-recording
    Risk Management, Knowledge Management and the Risk
    https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution
    Understanding the Concept of Formality In Quality Risk ...
    https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management
    Quality Management Maturity – A Pilot Program of the FDA
    https://www.ivtnetwork.com/article/quality-management-maturity-%E2%80%93-pilot-program-fda
    ICH Q9 R1 concept document
    https://database.ich.org/sites/default/files/Q9-R1_Concept%20Paper_2020_1113.pdf
    ICH Q14 Concept Paper
    https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf
    2021 Updated PIC/s Aide Memoire on Assessment of QRM Implementation
    https://picscheme.org/docview/3823
    Sept 24 2021 Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle
    https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-notices/gc-1220-pre-post-20210924.pdf
    QRM: a Case for Convergence:
    https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1160&context=level3

    About Our Guest:
    Valerie Mulholland
    Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality Risk Management and is researching the topic of Risk-Based Decision Making for a Ph.D. dissertation with the Pharmaceutical Regulatory Science Team in TU Dublin.
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