In this episode of Risk Revolution, Nuala Calnan discusses trending topics impacting QRM system and process with special guest Valerie Mulholland. Listen in as they discuss ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more.
Resources from this episode:
- QRM: a Case for Convergence
- Risk-Based Decision Making: PODCAST RECORDING
- Risk Management, Knowledge Management, and the Risk
- Understanding the Concept of Formality In Quality Risk
- Quality Management Maturity – A Pilot Program of the FDA
- ICH Q9 R1 concept document
- ICH Q14 Concept Paper
- 2021 Updated PIC/s Aide-Memoire on Assessment of QRM Implementation
- Sept 24, 2021, Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle
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