Preparing for and Managing FDA Inspections

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

Why Should You Attend:

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

How can your company be prepared for an FDA inspection?

How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm?

What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator?

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.

Areas Covered in the Webinar:

• 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
• Discuss common pitfalls to avoid during an inspection

Who Will Benefit:

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