13: What's hot in QRM?
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13: What's hot in QRM?
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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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