Managing FDA Inspections from Readiness through Follow up Responses: One and a Half day In-Person Seminar

If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:

• Has your company ever been unprepared for an FDA inspection?
• How should one respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
• What the agency can and cannot ask for during an inspection?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

This course on managing FDA inspection will:

• Define the steps necessary to prepare for an FDA inspection
• Discuss details surrounding the management of inspections from announcement to close out meeting
• Offer responses to FAQs regarding typical inspector requests during inspections
• Define the methodology for responding to 483 and warning letters
• Offer templates for response letters
• Discuss common pitfalls to avoid during an inspection

This course will provide valuable assistance and guidance to all regulated companies (pharmaceutical, biopharmaceutical, biologics, medical device etc) that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:

• Internal Auditors
• Regulators
• Legal Departments
• Compliance Officers
• Validation Managers
• QC Managers
• QA Managers
• Facilities and Engineering Department Staff
• Compliance Consultants
• Senior Management