TGA on-site GMP audit of an overseas manufacturing site – what does it mean for an Australian regulatory affairs department (F9)
Speaker/s
- Mary Flannery, Regulatory Affairs Manager, Eli Lilly Australia
- Dr. Dragana Milic, Manager, Medical Devices Audit Section, Office of Manufacturing Quality, TGA
Chair
- Ailsa Surman, Regulatory Affairs Consultant, Eli Lilly
Synopsis
According to the TGA’s Guidance on GMP clearance for overseas manufacturers, the TGA reserves the right to undertake an on-site audit of an overseas manufacturing site. If this happens, the Australian sponsor regulatory affairs department is often the first point of contact for the TGA when an overseas on-site audit is planned. This session will describe the steps involved in arranging such an audit, how the Australian sponsor can help the site prepare, what happens during the audit, and what can be needed to close out an audit. Hear from a TGA auditor and an Australian regulatory professional who has accompanied a TGA audit about what can help make this a good experience for all concerned.
Learning Objectives
By attending this session you will:
- understand the preparatory activities required before an overseas on-site audit
- understand more about the link between your ARTG entries and what will be audited
- know what to expect during and after an audit
- learn some hints & tips about what helps an overseas on-site audit run smoothly
Level of Experience
Intermediate/Advanced
Canberra Sponsors
Gold
Silver
Bronze
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