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Recalls: Regulations, Decisions, Procedures and Best Practices Workshop

April 17, 2019 to April 18, 2019
Washington, DC
Regulatory, Legal and Compliance, Global
Workshop

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.

View the agenda here

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

Location:

The Westin City Center
1400 M St NW, Washington, DC 20005

Room rate:  $299
Cut-off date for room reservations:  Mar. 22, 2019
Book your group rate for the workshop here

Speakers will include:

  • Kathryn Klaus, Risk Management Attorney, FDA Specialist, Medmarc
  • Ted Wilson, Hogan Lovells
  • Mike Heyl, Hogan Lovells 

Registration Fees

AdvaMed Accel Member Registration: $695.00

AdvaMed Member Registration: $1,595.00

Non-Member Registration: $2,095.00