Upgrade Your Medical Device Recall Strategy – Webinar Recording/Transcript
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.
Ginger Glaser, chief technology officer at Monteris Medical, will show you how your current recall plan likely overlooks important details. By describing many of these potential issues, you will be able to think through the entire business impact and make better decisions along the way. She will explain how to upgrade your plan and improve your decisionmaking around recalls, ultimately allowing for less confusion among stakeholders and a faster and more organized recall recovery.
- 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.
Meet Your Presenter
Ginger Glaser has spent 25 years in the medical device industry, most recently as chief technology officer at Monteris Medical. She had leadership roles of increasing responsibility in regulatory affairs, clinical affairs, quality, operations, R&D and project management. During her career, Ms. Glaser has been directly responsible for field actions/recalls at times and participated as part of the strategic team on many others. She realized that important details in executing recalls were often overlooked, leading to last-minute stress and frustration, not to mention missed opportunities. Her participation in acquisitions due diligence further identified a lack of planning for the diverse business and regulatory impacts inherent in recall situations. Ms. Glaser is a certified Regulatory Affairs Professional. She is currently a part-time consultant to Monteris Medical.
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)
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Aug. 6, 2020