GMP Forum 2024

Presentations given by the TGA at the GMP Forum 19-20 November, Melbourne Convention and Exhibition Centre.

Presentations

• Session 2 - GMP Forum 2024 Keynote presentation (pdf,1165kb)
• Session 3 - Manufacture of Sterile Medicines - The countdown to Annex 1 (pdf,2304kb)
• Session 4 - Complementary and listed medicines - GMP 101 (pdf,2176kb)
• Session 5 - Submitting effective GMP clearance applications (pdf,1582kb)
• Session 6 - How to do an effective recall (pdf,770kb)
• Session 7 - GMP clearance - Addressing application deficiencies (pdf,1543kb)
• Session 8 - Submitting effective GMP licence applications (pdf,690kb)
• Session 9 - Successful inspections - Before, during and after (pdf,2181kb)
• Session 10 - Medicinal cannabis supply chains - Know your obligations (pdf,2744kb)
• Session 11 - Recalls 101 (pdf,1356kb)
• Session 12 - Workshop: Performing Detailed Investigations (pdf,1091kb)
• Session 13 - Recall Reforms - The Future of market actions (pdf,1510kb)
• Session 14 - Investigational medicinal products – Expectations and effective risk mitigation (pdf,1047kb)
• Session 15 - Laboratory testing for biologicals (pdf,1194kb)
• Session 16 - GMP Clearance: How we got here and where we are headed (pdf,7572kb)
• Session 17 - Innovations in Biologicals from Concept to Care (pdf,2739kb)
• Session 18 - MDMA and Psilocybine (pdf,839kb)
• Session 19 - How to Manage GMP Compliance Signals - For sponsors and manufacturers of medicines and biologicals (pdf,912kb)
• Session 20 - Improving TGA's services: Modernising digital systems (pdf,2321kb)
• Session 21 - Does my GMP evidence comply with TGO 93 (pdf,986kb)
• Session 22 - Computerised Systems: Current and future considerations (pdf,4936kb)
• Session 23 - Common deficiencies identified at inspection (pdf,1823kb)
• Session 26 - Class II Biologicals - Validations and inspection observations (pdf,1529kb)
• Session 27 - Release for supply (batch certification) - Meeting your obligations as an authorised person (pdf,2920kb)
• Session 28 - GMP requirements for medicinal cannabis manufacture (pdf,1348kb)
• Session 29 - Where does GMP for plants and herbs begin (pdf,7482kb)
• Session 32 - PIC/S: TGA's Adoption process and future revisions (pdf,1365kb)
• Session 33 - International GMP - Collaboration, alignment, harmonisation (pdf,25805kb)
• Session 34 - Advanced therapy medicinal products - Medicines and biologicals (pdf,kb)