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.
This event has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- Ron Brown, Office of Compliance, FDA
- Maureen Bernier, Office of Compliance, FDA
- Patricia Shrader, Vice President, Global Regulatory Affairs, Medtronic
- Hillary Medina, Director of Recalls, Novasyte
- Sara Dyson, Assistant Vice President, Risk Management, Medmarc
- Mary Swift, Senior Manager, Regulatory Affairs Operations, Terumo Cardiovascular Group
- Lee Zeidman, 3D Communications
- Ginger Glaser, Vice President of Engineering, Monteris Medical
701 Pennsylvania Ave., N.W., Ste. 800
Washington, DC 20004
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. 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 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.