Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put your company in the best position with the FDA. 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. The standard format of the 483 response is given along with an explanation there of.
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
How to put your company in the best light with FDA regarding the response
What to include as attachments
What to include in the response itself
Who Will Benefit:
Manager/Director Regulatory Affairs
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. 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. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.