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