Responding to FDA 483`s 2012

Topics

• Using the preferred format
• How to respond to an FDA Form 483
• The wording and tone of the response
• The timing of the response
• What to include as attachments
• How to put your company in the best light with FDA regarding the response
• What to include in the response itself

Who should Attend

Manager/Director Regulatory Affairs and Manager/Director QA.