Events

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

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

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.

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.

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

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

A webinar about manufacturing quality perspective.

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

An introduction to the Australian Unique Device Identification system

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

TGA presentation slides from Recent Developments in Global Regulation of Gene Therapies, ACT (11 May 2021).