C1A: Manufacture of Sterile Medicines – The Countdown to Annex 1
Tracks
Goldfields Theatre Breakout 1
| Tuesday, November 19, 2024 |
| 10:30 AM - 11:00 AM |
Details
This presentation explores the adoption of the updated Annex 1 of the PIC/S GMP Guidelines for sterile medicinal products, and provides a roadmap for manufacturers to help ensure compliance. The presentation will describe key changes and outline practical steps companies should take to prepare. Emphasis will be placed on Gap Analysis, Contamination Control Strategies, upgrading facilities, revision of the Pharmaceutical Quality System and fostering a culture of continuous quality improvements to meet the new regulatory guidance.
Speaker: Matt Davis, Senior GMP Inspector & Team Leader, Inspections Section
Matt Davis is a Senior Inspector and Team Leader in the GMP inspections section of Manufacturing Quality Branch. Matt has been with TGA since 2009. Before joining the TGA, Matt held positions in the pharmaceutical industry in both quality and technical roles, and has spent time in the UK as a GMDP Inspector for the Medicines HRA.
Matt was the Co-Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.
Speaker: Matt Davis, Senior GMP Inspector & Team Leader, Inspections Section
Matt Davis is a Senior Inspector and Team Leader in the GMP inspections section of Manufacturing Quality Branch. Matt has been with TGA since 2009. Before joining the TGA, Matt held positions in the pharmaceutical industry in both quality and technical roles, and has spent time in the UK as a GMDP Inspector for the Medicines HRA.
Matt was the Co-Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.
