Inspection Readiness for a More Aggressive FDA Part 2

Venue: Complimentary online conference

Location: Toronto, Canada

Event Date/Time: May 13, 2010 End Date/Time: May 13, 2010
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It is the goal of every company during an FDA Inspection to have no FDA 483 observations at the end of the inspection. However, is this realistic, particularly in light of the FDA’s new enforcement approaches?On Aug 6th , 2009 FDA Commissioner, Margaret Hamburg announced that FDA will be taking a much more aggressive approach to FDA enforcement.

This means it is much more important for companies to “get it right” before the FDA walks in the door, and that the Quality organization must be:

- Ready to display the process and procedural controls used in your operation;
- Ready to demonstrate easy access to records and to provide copies of the records that do exist; and
- Ready to respond quickly in case there is an observation.

Preparing for an FDA inspection requires robust systems, well constructed documents, proper training, appropriate computer-based tools, and lots of preparation for the event. This Webinar will review the essential elements that FDA Investigators look for and will review techniques for assuring your controls and records are ready for review. Finally we will touch on important information to be considered when responding to the FDA if a FDA 483 is issued.