Events

A presentation on the role of a UDI Issuing Agency, including project update and Q&A.

The role nicotine vaping products can play in a person's journey to quit

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

UDI Webinar No. 4 - recording now available

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.

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

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

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.

Webinar presentation on regulatory flexibilities and performance during the pandemic.

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

A webinar about manufacturing quality perspective.

An introduction to the Australian Unique Device Identification system

Special Access Scheme - portal updates.

An overview of TGA's proposed safety and quality requirements for unapproved vaporiser nicotine products.

Guidance for industry on the new regulatory framework for personalised medical devices commencing on 25 February 2021.