Risk Revolution: ICH Q9 Revision, Is it enough?

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.

In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to be explored further.

Resources from this episode:

ICH Q9 Quality Risk Management Revision 

Link to the new guidance

Understanding the Concept of Formality In Quality Risk ...

Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution

Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?

Q9R1 presentation

About Our Guest:

Kate Coleman

Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor and an SME in Risk Management, New Facility Design/Start Up, QC and Sterility Assurance.

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.