FDA Policy and Goals Regarding the 483 Response - 2017
- Start Date:
- Tuesday, 6 June, 2017
- End Date:
- Tuesday, 6 June, 2017 11:00am
- Health & Nutrition
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: 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 itselfWho Will Benefit: Manager/Director QA Manager/Director Regulatory AffairsSpeaker 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: +1-800-447-9407Email: support@compliance4All.com
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Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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