Medical Device Recall – FDA Authority, Policy and Best Practices to Avoid and Manage

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Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. FDA’s recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The recall management knowledge you gain will sharpen how you determine the health and legal risks associated with your recall and what you can do to avoid future recalls. You will understand the critical performance targets to accomplish an effective recall and learn how missteps in the recall process become counterproductive and expensive. You will take away practical knowledge on how to work with FDA staff during a recall and how you can prepare for inspectional follow up or an enforcement action. You will learn that your approach to an enforcement action plays a major role in mitigating the firm’s business consequences due to a recall. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the likelihood or significance of a recall with proper planning.

Areas to be Covered:

Understand FDA’s recall authority and policy
Learn the mandatory requirements for device recalls
Learn how to interact with FDA
See how to develop health risk determinations
Learn critical recall strategy components
Identify options for FDA enforcement action

Who will Benefit:

Quality & Regulatory Professionals
Manufacturing & Design Engineers
Marketing Product Managers
Documentation Personnel
Complaint Handling Personnel
Clinical Affairs Teams
Product and Development Teams
Site Managers and consultants
Contract manufacturing organization
Contract research organization
Senior and executive management
Contractors and subcontractors

Casper E. Uldriks

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

This product is currently out of stock and unavailable.

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  • Presentation Handout in .pdf format
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