Product Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know
November 29, 2012 - Palo Alto CA US
This webinar will discuss important regulatory requirements and practical considerations for recalls of drugs, biologics, and medical devices regulated by the Food and Drug Administration (FDA). Why Should You Attend: Despite drug and device manufacturers’ best efforts to ensure to the quality of their products, at some point virtually all such companies will face the possibility of needing to recall one (or more) of their products. The way they evaluate these situations, what steps they decide to take, and the extent of the involvement of FDA will determine how efficiently (and with what degree of disruption to the business) the recall can be completed. This session is designed for manufacturers of finished drugs, biologics, and medical devices, along with companies that supply important components to these manufacturers. It will provide an overview of the legal basis for product recalls and the extent of FDA’s authority over them. It will also address many practical considerations to help companies prepare for and conduct a recall, make appropriate decisions under what can otherwise be very stressful circumstances, and be prepared for the follow-up scrutiny from FDA that is almost certain to follow. At the end of this webinar the speaker will answer questions you may have related to product recall guidance for drugs, biologics and medical devices. Areas Covered in the Webinar: - Scope of FDA’s recall (and recall oversight) authority. - Identifying when a recall is appropriate. - Determining when a product recovery constitutes a “recall” and not another type of action. - How to prepare for a recall and steps to take to ensure that the situation is handled correctly and efficiently. - Considering when (or whether) to notify FDA of the recall. - Weighing the potential consequences of not conducting a recall. - Introducing a product back into the market.