C4C: Does My GMP Evidence Comply with TGO93?
Tracks
Courtyard Room Seminar
| Tuesday, November 19, 2024 |
| 4:30 PM - 5:00 PM |
Details
Manufacture of medicinal cannabis must occur at sites that comply with one of the GMP standards in subsection 13(2) of TGO 93, and the Australian sponsor of the medicinal cannabis product must hold evidence of GMP compliance in accordance with subsection 13(3) of TGO 93.
How do you know if the GMP evidence you have complies with TGO 93 requirements?
This seminar will provide an overview of GMP evidence requirements and includes hands on activities to help participants identify whether GMP evidence complies or does not comply with TGO 93.
Speaker: Nicole Bottle, Assistant Director, GMP operations and Strategy Section
Nicole is an Assistant Director in the GMP Operations and Strategy Section of Manufacturing Quality Branch. Nicole joined the TGA in October 2023 to manage regulatory reform work within the branch, and has focused on reforms to the regulation of medicinal cannabis, MDMA and psilocybine. Prior to joining the TGA, Nicole was at the Department of Agriculture, Fisheries and Forestry working on a range of projects to implement regulatory controls to manage biosecurity risks.
Speaker: Gaye Camm, Senior GMP Inspector Medicines, Manufacturing Quality Branch
Gaye is a Senior GMP Inspector within the Manufacturing Quality Branch. They have an Honours Chemistry degree and 30+ years working within TGA as both an analytical chemist and GMP Inspector. Gaye is a technical specialist for GMP related to manufacture of listed and complementary medicines, medicinal cannabis, sunscreens and medical gases, and GMP related to QC testing and management of laboratory electronic data capture systems. Gaye currently co-chairs the TGA-Industry Working Group on GMP for Complementary and Listed Medicines.
How do you know if the GMP evidence you have complies with TGO 93 requirements?
This seminar will provide an overview of GMP evidence requirements and includes hands on activities to help participants identify whether GMP evidence complies or does not comply with TGO 93.
Speaker: Nicole Bottle, Assistant Director, GMP operations and Strategy Section
Nicole is an Assistant Director in the GMP Operations and Strategy Section of Manufacturing Quality Branch. Nicole joined the TGA in October 2023 to manage regulatory reform work within the branch, and has focused on reforms to the regulation of medicinal cannabis, MDMA and psilocybine. Prior to joining the TGA, Nicole was at the Department of Agriculture, Fisheries and Forestry working on a range of projects to implement regulatory controls to manage biosecurity risks.
Speaker: Gaye Camm, Senior GMP Inspector Medicines, Manufacturing Quality Branch
Gaye is a Senior GMP Inspector within the Manufacturing Quality Branch. They have an Honours Chemistry degree and 30+ years working within TGA as both an analytical chemist and GMP Inspector. Gaye is a technical specialist for GMP related to manufacture of listed and complementary medicines, medicinal cannabis, sunscreens and medical gases, and GMP related to QC testing and management of laboratory electronic data capture systems. Gaye currently co-chairs the TGA-Industry Working Group on GMP for Complementary and Listed Medicines.
