Medical Device 2020 - Upgrade Your Medical Device Recall Strategy

Recalls are inevitable. Even the most robust quality and compliance processes can’t prevent all situations that require a field correction or removal.
Recall situations are diverse and can be complex, often negatively impacting the larger business in many ways. This despite regulatory, quality and service personnel executing the recalls according to their understanding of the regulations and your company’s internal processes.
An overview of FDA requirements for recalls of medical devices, analysis of guidelines and development of a recall strategy
Definitions of corrections vs. removals
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.