Inspection Readiness for a More Aggressive FDA Part 2
|Event Date/Time: May 13, 2010||End Date/Time: May 13, 2010|
This means it is much more important for companies to â€œget it rightâ€ 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.