C5C: Recalls 101 (Repeat)
Tracks
Courtyard Room Seminar
| Wednesday, November 20, 2024 |
| 9:00 AM - 9:45 AM |
Details
The world is imperfect, including during the manufacture of therapeutic goods. Things do go wrong from time-to-time and when this happens, products may have to be recalled from the Australian market or other actions need to be taken to ensure consumer safety. Would you know what to do if you needed to recall your product? Or have you done recalls in the past and would like a refresher on the processes? In this session, we will provide an overview of Australia’s recall processes. We will also focus on sponsors’ roles and responsibilities which aim to ensure their recall actions are conducted effectively.
Speaker: Sharon Bennett, Assistant Director, Recalls Section
Sharon Bennett has worked for the TGA for approx. 16 years. She recently moved to the position of Deputy Australian Recall Coordinator (Assistant Director) in the Recalls Section of the Manufacturing Quality Branch, after gaining extensive regulatory experience in Medical Device post-market areas.
Sharon has 20 years’ experience in nursing, incorporating areas such as chemotherapy, rehabilitation, surgical, aged care and dialysis. Sharon has a Bachelor of Nursing and Nephrology Nursing Certificate and a Cert IV in Government Investigations.
Speaker: Brigida Botticelli, Recall Coordinator, Recalls Section
Brigida Botticelli is an Italian pharmacist with 10-year experience in the pharmacy sector, who joined the Recalls section of the MQB in August 2023.
Her expertise lies in medication counseling, prescription verification and therapeutic recommendations.
In her current role as a Recall Coordinator, Brigida oversees recall and non-recall actions of Therapeutic Goods in Australia prioritising public safety and regulatory compliance as well as ensuring timely and effective recall processes.
Speaker: Sharon Bennett, Assistant Director, Recalls Section
Sharon Bennett has worked for the TGA for approx. 16 years. She recently moved to the position of Deputy Australian Recall Coordinator (Assistant Director) in the Recalls Section of the Manufacturing Quality Branch, after gaining extensive regulatory experience in Medical Device post-market areas.
Sharon has 20 years’ experience in nursing, incorporating areas such as chemotherapy, rehabilitation, surgical, aged care and dialysis. Sharon has a Bachelor of Nursing and Nephrology Nursing Certificate and a Cert IV in Government Investigations.
Speaker: Brigida Botticelli, Recall Coordinator, Recalls Section
Brigida Botticelli is an Italian pharmacist with 10-year experience in the pharmacy sector, who joined the Recalls section of the MQB in August 2023.
Her expertise lies in medication counseling, prescription verification and therapeutic recommendations.
In her current role as a Recall Coordinator, Brigida oversees recall and non-recall actions of Therapeutic Goods in Australia prioritising public safety and regulatory compliance as well as ensuring timely and effective recall processes.
