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During this workshop you'll establish a clear understanding how the regulatory affairs function is pivotal to every recall and every team decision. After partaking in detailed discussions and strategies of communicating with the FDA, you'll learn to understand the points to consider when writing public recall notifications. At this interactive workshop, you will have access to network with industry leaders and FDA experts.
Topics will include:
- Definitions, Practices, and Current FDA Perspective
- Recall Procedures
- Mobilizing and Deploying a Field Based Team During a Recall
- Communicating with FDA–Before, During and After–and What are the RegulatoryRequirements and Expectations?
- Special Situations
- Product Liability Considerations
- Effectiveness Checks and Status Reports
- Crisis Management and Recalls–Preparedness & Infrastructure
- Creating a Recall Strategy
The Westin City Center
1400 M St NW, Washington, DC 20005