WS3: How to Manage GMP Compliance Signals
Tracks
Eureka Room 1 Workshop
| Tuesday, November 19, 2024 |
| 3:30 PM - 4:00 PM |
Details
TGA licensed manufacturers and Australian sponsors are responsible for reporting information to the TGA when they become aware of GMP non-compliance at sites used to manufacture their medicines.This workshop will explore what a GMP compliance signal is, the responsibilities of manufacturers and sponsors when you become aware of a signal, the type of information you need to provide, and what actions the TGA may take. Participants will work through a case study to gain a better understanding of these responsibilities.
Speaker: Katherine Clark, Director, GMP Operations and Strategy Section, Manufacturing Quality Branch, TGA
Katherine has a PhD in cell biology and worked for over 10 years in medical research before joining the TGA in 2002. Katherine has worked in various roles in the regulation of medicines and biological products including as an evaluator of biotechnology products and as a GMP inspector team leader for biological and cell therapy manufacturers. Katherine also has experience as a Good Clinical Practice (GCP) inspector and led the GCP inspection pilot program in Australia. In her current role as Director of GMP Operations and Strategy she has responsibility for the business operations of MQB including data reporting systems, the Quality Management System and cost recovery arrangements. The section is also responsible for GMP regulatory reforms including the introduction of quality standards for psilocybine and MDMA and the GMP requirements for medicinal cannabis. In addition, she is responsible for MQB’s GMP signal investigation processes and compliance and enforcement activities.
Speaker: Katherine Clark, Director, GMP Operations and Strategy Section, Manufacturing Quality Branch, TGA
Katherine has a PhD in cell biology and worked for over 10 years in medical research before joining the TGA in 2002. Katherine has worked in various roles in the regulation of medicines and biological products including as an evaluator of biotechnology products and as a GMP inspector team leader for biological and cell therapy manufacturers. Katherine also has experience as a Good Clinical Practice (GCP) inspector and led the GCP inspection pilot program in Australia. In her current role as Director of GMP Operations and Strategy she has responsibility for the business operations of MQB including data reporting systems, the Quality Management System and cost recovery arrangements. The section is also responsible for GMP regulatory reforms including the introduction of quality standards for psilocybine and MDMA and the GMP requirements for medicinal cannabis. In addition, she is responsible for MQB’s GMP signal investigation processes and compliance and enforcement activities.
