C1C: Submitting Effective GMP Clearance Applications
Tracks
Courtyard Room Seminar
Tuesday, November 19, 2024 |
10:30 AM - 11:00 AM |
Details
Submitting effective GMP Clearances applications can be challenging with many variables at play. It can be easy to make mistakes which result in your application being identified as incomplete. Over 10% of submitted applications end up in this situation. This session will explain how to avoid this as well as other common pitfalls with the application process.
Speaker: Samuel Borg, Assistant Director, GMP Clearance Section
Samuel is an Assistant Director in the GMP Clearance section of the Manufacturing Quality Branch (MQB) and joined the TGA in July 2019.
Prior to joining the TGA, he has experience working in manufacturing facilities in both pharmaceutical aseptic compounding of oncology products and laboratory management in the FMCG industry. Samuel has a Bachelor of Science (Microbiology) and a Graduate Diploma in Environmental Health Practice.
Speaker: Samuel Borg, Assistant Director, GMP Clearance Section
Samuel is an Assistant Director in the GMP Clearance section of the Manufacturing Quality Branch (MQB) and joined the TGA in July 2019.
Prior to joining the TGA, he has experience working in manufacturing facilities in both pharmaceutical aseptic compounding of oncology products and laboratory management in the FMCG industry. Samuel has a Bachelor of Science (Microbiology) and a Graduate Diploma in Environmental Health Practice.