C3B: Investigational Medicinal Products - Expectations and Effective Risk Mitigation
Tracks
Eureka Room 2&3 Breakout 2
| Tuesday, November 19, 2024 |
| 2:05 PM - 3:00 PM |
Details
Annex 13 of the PIC/S guide to GMP describes requirements specific to the manufacture of Investigational Medicinal Product (IMP). With the update providing significant clarification of the requirements, this session will focus on areas of common deficiencies observed during TGA inspections of IMP manufacturers. The session will also explain why IMP is potentially a higher risk class of products and why it is important to apply an appropriate level of GMP.
Speaker: Lynn Talomsin, Senior GMP Inspector, Inspections Section
Lynn joined the TGA in 2009 and is currently a Senior GMP Inspector and non-sterile registered medicine Technical Specialist within the Manufacturing Quality Branch. Lynn conducts inspections of domestic and overseas manufacturers of API, and non-sterile and sterile finished dosage forms.
Lynn worked for a number of companies in the pharmaceutical industry for over 20 years prior to joining the TGA, holding various positions in R&D, Operations and Quality. During this time, she held managerial positions as well as project management lead roles implementing quality and process improvement projects.
Speaker: Lynn Talomsin, Senior GMP Inspector, Inspections Section
Lynn joined the TGA in 2009 and is currently a Senior GMP Inspector and non-sterile registered medicine Technical Specialist within the Manufacturing Quality Branch. Lynn conducts inspections of domestic and overseas manufacturers of API, and non-sterile and sterile finished dosage forms.
Lynn worked for a number of companies in the pharmaceutical industry for over 20 years prior to joining the TGA, holding various positions in R&D, Operations and Quality. During this time, she held managerial positions as well as project management lead roles implementing quality and process improvement projects.
