FDA Policy and Goals Regarding the 483 Response - 2017
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Category FDA Policy and Goals, FDA Form 483, Regulatory Affairs, FDA Compliance Webinars, global regulatory affairs, online Fda Webinars, pharmaceutical regulatory affairs, Online Fda Programs, 2017 Fda Webinars, latest 2017 webinars, USA webinars
Deadline: June 06, 2017 | Date: June 06, 2017
Venue/Country: Online, U.S.A
Updated: 2017-04-24 18:31:22 (GMT+9)
Call For Papers - CFP
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 483Using the preferred formatThe timing of the responseThe wording and tone of the responseWhat to include as attachmentsWhat to include in the response itselfWho Will Benefit:Manager/Director QAManager/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: supportcompliance4All.com
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