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
801 Pennsylvania Ave NW | Conference Center
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00
Cancellation and Refund Policy
All cancellations must be received via email to firstname.lastname@example.org (link sends e-mail). Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact us at email@example.com (link sends e-mail) with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.