C2A: Successful Inspections – Before, During and After
Tracks
Goldfields Theatre Breakout 1
| Tuesday, November 19, 2024 |
| 1:00 PM - 1:55 PM |
Details
Inspections are a crucial tool the TGA use to assess and monitor a manufacturer’s compliance with GMP. The importance of preparing for inspection, behaviours during inspection, and efficient correspondence during the close out of the inspection dictates how effective the overall inspection process will be.
This session will explore a TGA inspector’s perspective and expectations for inspection preparation, conduct, and post inspection activities that allow the inspection process to proceed smoothly and achieve a positive outcome for the manufacturer.
Speaker: Maurice Makdessi, Senior GMP Inspector & Team Leader, Inspections Section
Maurice joined the TGA in 2009, he is currently a team leader in the Inspections section. He has science, engineering and management qualifications to masters level and has over 20 years’ experience in the Pharmaceutical industry and held management posts in quality assurance, quality control, production, and R&D at multinational companies in Australia and Overseas. He contributed to research work in teams developing synthetic active pharmaceuticals and finished dose formulations. He also worked earlier on, in forensic toxicology in research, developing analytical methods for quantitation of drug of abuse residue and trace elements in blood and tissue samples.
Speaker: Gaye Camm, Senior GMP Inspector, Inspections Section
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.
This session will explore a TGA inspector’s perspective and expectations for inspection preparation, conduct, and post inspection activities that allow the inspection process to proceed smoothly and achieve a positive outcome for the manufacturer.
Speaker: Maurice Makdessi, Senior GMP Inspector & Team Leader, Inspections Section
Maurice joined the TGA in 2009, he is currently a team leader in the Inspections section. He has science, engineering and management qualifications to masters level and has over 20 years’ experience in the Pharmaceutical industry and held management posts in quality assurance, quality control, production, and R&D at multinational companies in Australia and Overseas. He contributed to research work in teams developing synthetic active pharmaceuticals and finished dose formulations. He also worked earlier on, in forensic toxicology in research, developing analytical methods for quantitation of drug of abuse residue and trace elements in blood and tissue samples.
Speaker: Gaye Camm, Senior GMP Inspector, Inspections Section
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.
