ACI Legal, Quality, Regulatory, and Compliance Forum on Current Good Manufacturing Practices
January 23, 2014 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
January 23, 2014
Washington Plaza Hotel