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Recalls from A to Z: Regulations, Decisions, Procedures, and Best Practices

March 29, 2017 to March 30, 2017
Washington, DC
Regulatory
Workshop

Overview

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.

 


This workshop is supported by:

Speakers

Speakers include:

  • 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

Event Logistics

AdvaMed Offices
701 Pennsylvania Ave., N.W., Ste. 800
Washington, DC 20004
 

Cancellation and Refund Policy
All cancellations must be received via email to AdvaMedEvents@AdvaMed.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 AdvaMedEvents@AdvaMed.org 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.

Additional Info

Registration Fees

AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00