How to undergo an FDA Inspection Successfully

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

Why Should You Attend:

This training provides an overview of how FDA conducts inspections of Pharmaceutical firms and laboratories. Beginning with FDA’s expectations of the personnel, site and laboratories and then moving on to the SOP’s and documentation that they will expect to review.

This training also covers how to manage the inspection from the time the investigator appears at your door until finishing the closing meeting if in the US. Or if a preannounced international inspection, what to do from the time they contact you to set a date to when you finish the closing meeting

And finally, it covers the persons participating in the inspection and their various roles and organization. This way everyone is prepared in advance and more relaxed because they know what to expect.

Areas Covered in the Webinar:

• Preparation of the site before FDA arrives
• Personnel
• Documents
• Housekeeping
• Laboratory
• Manufacturing spaces and equipment Documents

What to do when FDA arrives

• Logistics
• Meeting room, during inspection
• Back room, during inspection

Who Will Benefit:

All management and QA personnel working in the Pharma industry as well as SME’s and supervisory personnel