Events

This presentation delivered on behalf of the TGA to the students at the University Technology of Sydney as part of the Master of Pharmacy course

Australian Influenza Vaccine Committee (AIVC) meeting

Advisory Committee on Medicines (ACM) meeting

Advisory Committee on Vaccines (ACV) meeting

TGA presentation slides from Vl all Russia Good Manufacturing Practice (GMP) Conference (22 September 2021).

This session will provide information on the creation of UDIs and the role of an Issuing Agency.

Advisory Committee on Medicines (ACM) meeting

TGA presentation slides from NSW Active MedTech Webinar (8 September 2021).

Advisory Committee on Vaccines (ACV) meeting

Presentation from TGA Transformation Stakeholder Engagement Forums.

A general overview of contamination control in clean rooms for Biologicals.

Common validation errors observed in the GMP Clearance section.

Examples of GMP clearance applications common deficiencies.

Examples of GMP licence applications and common pitfalls.

An update on the adoption of the PIC/S Guide to GMP version 14.

A webinar about legislative and regulatory changes for listed medicine manufacturers and an overview of common issues identified during GMP inspections of listed medicine manufacturers.

An update of the impact that COVID-19 has had on the GMP Clearance framework, and a review of the broader implications on global inspection reliance.

An overview of the legislative and GMP requirements of manufacturing of investigational medicinal products and common issues observed in inspections.

An overview and update of the Manufacturing Quality Branch on GMP regulatory activities.

An introduction of TGA hybrid and remote GMP inspections for domestic and overseas manufacturers.

A virtual tour around an imaginary sterile facility.

Presentations from the GMP Forum 2021 have been published.

A presentation and Q&A on UDI from a perspective of a global medical technology company.

Webinar presentation on regulatory flexibilities and performance during the pandemic.

Common deficiencies and FAQs from the GMP inbox.