Event

ACI Legal, Quality, Regulatory, and Compliance Forum on Current Good Manufacturing Practices

January 23, 2014 {ml-event-to} January 24, 2014

FDA Partner Gary Yingling will present at the American Conference Institute’s Legal, Quality, Regulatory, and Compliance Forum on Current Good Manufacturing Practices.

Mr. Yingling’s session will focus on strategies for handling an FDA inspection, including:

  • Establishing internal protocols for FDA inspections - domestic vs. international inspection protocols
  • Creating an atmosphere of constant preparedness and compliance to meet  482 “Notice of Inspection” and accompanying credentials
  • Identifying and addressing risk areas prior to and during an inspection - technically compliant vs. medically compliant
  • Deciding and knowing who should be present during an inspection - when does it make sense to have in-house counsel present?
  • When should you call for outside help?
  • Knowing what can be legitimately inspected under current FDA guidelines
  • Handicapping FDA field office procedures and findings
  • Creating a dialogue with inspectors and understanding how to best work with FDA
  • Developing strategies that can prevent field observations from becoming part of Form 483
  • Preparing for violation findings and executing a response strategy
When:
January 23, 2014
3:45–4:45 pm
 
Where:
Washington Plaza Hotel
Washington, D.C.