WS6: Performing Detailed Investigations (Repeat of WS2)
Tracks
Eureka Room 1 Workshop
| Wednesday, November 20, 2024 |
| 1:30 PM - 2:00 PM |
Details
One of the most common deficiencies observed during GMP inspections is inadequate investigations of process deviations, Out of Specification results or complaints. In this workshop, participants will work through a scenario and discuss the TGA’s expectations as well as the principles you need to follow to perform better investigations in your roles.
Speaker: Jenny Hantzinikolas, Director, Inspections Section
Jenny Hantzinikolas is the Director of the Inspections Section in the Manufacturing Quality Branch in TGA. She has a degree in Biochemistry and Microbiology. She leads a team of Inspectors who inspect medicines and blood and biological products manufacturers within Australia and overseas. She has been with the TGA for 20 years and was in industry for 17 years. Her experience in industry was in mostly bacterial and viral vaccines and also some experience in oral and topical non sterile medicines.
Speaker: Jenny Hantzinikolas, Director, Inspections Section
Jenny Hantzinikolas is the Director of the Inspections Section in the Manufacturing Quality Branch in TGA. She has a degree in Biochemistry and Microbiology. She leads a team of Inspectors who inspect medicines and blood and biological products manufacturers within Australia and overseas. She has been with the TGA for 20 years and was in industry for 17 years. Her experience in industry was in mostly bacterial and viral vaccines and also some experience in oral and topical non sterile medicines.
