The Therapeutic Goods Administration (TGA), in conjunction with RACI, ARCS, PDA Australia and ISPE, invites you to attend the second annual Good Manufacturing Practice (GMP) Forum, GMP2
The Forum provides an opportunity to learn about good manufacturing practice relating to prescription, over-the-counter and complementary medicines.
The program and speakers for the 2nd GMP Forum are still being finalized but the following topics will be featured:
- Common inspection deficiencies and emerging issues
- Computerized systems - trends observed at inspections
- Medicinal cannabis - an overview of GMP requirements
- "A day in the life of a GMP inspector"
- PIC/S Guide to GMP
- Version 13 chapter and annex overviewsThe future: Version 14 and beyond
- GMP Clearance:
- Where we are now, future direction and focus
- GMP Agreements and PIC/S Guide to GMP
- Answers to industry’s most frequently asked questions
- New and emerging technologies
Speakers will include senior officials and subject matter experts from both the TGA and medicines industry. The program will be delivered through a mix of formal presentations, interactive sessions and thought provoking panel discussions.
At this year's event, we will also have a dedicated ‘Meet the TGA’ break-out area. This will allow delegates to informally meet with some of the TGA's GMP inspectors and specialized staff from other business areas throughout the day.
Individuals with an interest in GMP for medicines, including:
Who Should Attend
- personnel involved in quality assurance, regulation, risk assessment of medicines
- personnel employed by sponsors and manufacturers of medicines
- active pharmaceutical ingredient manufacturers
- regulatory consultants in the therapeutic goods industry
- personnel involved in medicine-based small and medium enterprises