Events

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.

An overview of GMP compliance signals, how we manage these signals for manufacturers of medicines and biologicals and the kind of information that may be required in the assessment of these signals.

Advisory Committee on Medical Devices (ACMD) meeting

Advisory Committee on Medicines (ACM) meeting

Advisory Committee on Vaccines (ACV) meeting

Further considerations for the Australian UDI, including global alignment, GMDN and data elements.

Advisory Committee on Complementary Medicines (ACCM) meeting

A webinar about manufacturing quality perspective.

The 2nd meeting of the Australian Dental Sector Working Group (DSWG), June 2021.

TGA presentation slides from Queensland Cardiovascular Research Network Webinar (25 June 2021).

The 28th joint meeting of the Advisory Committees on Medicines Scheduling and Chemicals Scheduling (Joint ACMS-ACCS #28), June 2021.

The 34th meeting of the Advisory Committee on Medicines Scheduling (ACMS #34), June 2021.

The 31st meeting of the Advisory Committee on Chemicals Scheduling (ACCS #31), June 2021.

Advisory Committee on Vaccines (ACV) meeting

An introduction to the Australian Unique Device Identification system

Advisory Committee on Medical Devices (ACMD) meeting

Advisory Committee on Medicines (ACM) meeting

Advisory Committee on Vaccines (ACV) meeting

EU Medical Device Regulation changes and the implications for the TGA and Australia