C5B: GMP Inspection Deficiencies
Tracks
Eureka Room 2&3 Breakout 2
| Wednesday, November 20, 2024 |
| 9:00 AM - 9:45 AM |
Details
Deficiencies happen during an inspection and there are always lessons that can be learned from these. Understanding deficiencies raised at other manufacturing sites is valuable information that may better prepare you for your next TGA inspection.
This session will breakdown the most common inspection deficiencies identified during the past 12 months at both Australian and overseas manufacturers. It will provide a GMP inspector’s insights into the categories of deficiencies, the specific clauses repeatedly cited as well as examples of how these get identified during inspection.
Speaker: Jeff Wan, GMP Inspector, Inspection Section
Jeffery Wan is a GMP Inspector with the Manufacturing Quality Branch. Jeff has a wealth of inspection experience both at the TGA and as an auditor in the Asia Pacific Region in industry. Before joining the TGA he has spent 15 years in the pharmaceutical industry in a number of high level quality and production roles in both sterile manufacturing and FMCG (Fast Moving Consumer Goods) in consumer healthcare. He has a particular interest in BFS technology and has extensive expertise in project management systems and strategies.
This session will breakdown the most common inspection deficiencies identified during the past 12 months at both Australian and overseas manufacturers. It will provide a GMP inspector’s insights into the categories of deficiencies, the specific clauses repeatedly cited as well as examples of how these get identified during inspection.
Speaker: Jeff Wan, GMP Inspector, Inspection Section
Jeffery Wan is a GMP Inspector with the Manufacturing Quality Branch. Jeff has a wealth of inspection experience both at the TGA and as an auditor in the Asia Pacific Region in industry. Before joining the TGA he has spent 15 years in the pharmaceutical industry in a number of high level quality and production roles in both sterile manufacturing and FMCG (Fast Moving Consumer Goods) in consumer healthcare. He has a particular interest in BFS technology and has extensive expertise in project management systems and strategies.
