This episode originally aired on February 15th, 2022
In this episode, Nuala Calnan and Valerie Mulholland 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 - https://www.ivtnetwork.com/article/ich-q9-quality-risk-management-revision
Link to the new guidance - https://database.ich.org/sites/default/files/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf
Understanding the Concept of Formality In Quality Risk ... - https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management
Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution - https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution
Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare? - https://www.ivtnetwork.com/article/can-%E2%80%98fuzzy-logic%E2%80%99-be-applied-risk-management-pharmaceuticals-and-healthcare-risk-revolution
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.
