C6C: PIC/S: TGA’s Adoption Process and Future Revisions
Tracks
Courtyard Room Seminar
| Wednesday, November 20, 2024 |
| 12:00 PM - 12:30 PM |
Details
This seminar provides an overview of the process for adoption of updated versions of the PIC/S Guide to GMP. It highlights the main steps for guidance development, opportunities for consultation with industry, evaluation of changes and adoption. The presentation will also look at future revisions of the PIC/S Guide that are anticipated in the next revisions.
Speaker: Matt Davis, Senior GMP Inspector & Team Leader, Inspections Section
Matt Davis is a Senior Inspector – 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 sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA. 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 – 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 sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA. 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.
