- TypeWebinar
- Location San Diego, California, United States
- Date 06-06-2017
Education/Teaching/Training/Development
Medical/Healthcare/Hospital
Overview:
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:
Who Will Benefit:
Speaker Profile:
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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Form more details and updates please visit website.
Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: [email protected]
8004479407