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FDA Inspections, Warning Letters, & CAPA Workshop

October 5, 2017 to October 6, 2017
Washington, DC
Regulatory
Workshop

Are ​you ​prepared ​for ​the ​next ​FDA ​inspection? ​Do ​you ​know ​how ​to ​respond ​to ​a ​warning ​letter? ​FDA ​staff ​and ​industry ​experts ​will ​provide ​you ​the ​tools ​to ​avoid ​warning ​letters, ​enable ​you ​to ​demonstrate ​your ​compliance ​initiatives, ​and ​teach ​you ​how ​to ​respond ​to ​a ​warning ​letter. ​You'll ​learn ​how ​to ​properly ​integrate ​and ​implement ​your ​CAPA ​program ​to ​improve ​internal ​processes ​and ​products ​and ​better ​achieve ​business ​objectives. 
FDA ​staff, ​medical ​technology ​company ​leaders, ​legal ​experts ​and ​public ​affairs ​professionals ​will ​lead ​discussions. 

Click here to view and download the agenda

Agenda topics include:

  • Current FDA Inspection, Enforcement Trends, and Field Issues
  • Authority for FDA Inspections and the FDA Process
  • Managing an Inspection and Best Practices
  • Introducing CAPA
  • When to Use CAPA
  • Deep Dive - CAPA Inputs and Outputs
  • Creating an Effective CAPA Process
  • FDA Criteria for Determining what Items to List on a 483 and when the Agency will Issue a Warning Letter
  • Impact of Warning Letters on Product Liability
  • Interactive Session: How to Respond to 483s and Warning Letters

 

FDA Inspections, Warning Letters, & CAPA

October 5-6, 2017
PEW Conference Center
901 E Street, NW | Washington, DC

 

Registration Fees

Register by August 11th and get $200 off of registration with Early-Bird pricing!

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 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.