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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. Valerie answers questions about ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more.
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 the ways in which they perceive and manage risk.
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
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.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. |