FDA Policy and Goals Regarding the 483 Response - 2017

FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given.

Why you should attend:

Learn how to respond to FDA 483's and the best way to write the response. Learn the new policy from FDA regarding how and when to respond. Learn the best way to respond in case a Warning Letter is issued. Learn what is a satisfactory response to FDA and what is not.

Areas Covered in the Session:

How to respond to an FDA Form 483
Using the preferred format
The timing of the response
The wording and tone of the response
What to include as attachments
What to include in the response itself

Who Will Benefit:

Manager/Director QA
Manager/Director Regulatory Affairs

Speaker and Presenter Information

John R. Godshalk

Senior Consultant, Biologics Consulting Group

John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy.