Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
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
- A discussion of potential impacts of recalls or corrective actions in one or more geographical areas as part of a global business
- Business and communications questions to consider while creating your strategy and how business, marketing and regulatory should be interacting
- Examples of various recall situations and the specific strategy elements that ought to be considered
Yes, recalls are inevitable. But with this presentation, you’ll develop better recall plan strategies, reduce negative business impacts and ensure less confusion among stakeholders. You can’t afford to miss it. Join us by registering today.
Can't Make this LIVE Webinar?
Simply select the Recorded option when registering and we will send you the link to view the recorded version.
Who Will Benefit
Personnel who are responsible for overall recall decisions and/or execution, particularly:
- Regulatory personnel
- Quality personnel
- Aspiring regulatory and quality leaders/senior leaders
- Members of recall Teams (from functional areas such as Operations, Service and Marketing)
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.