Points to Consider when Presenting Documents for an FDA Inspection

It used to be that all controlled documents were stored as hard copy in a document center where they would be signed out for presentation to inspectors. These days, records are stored in a variety of computerized systems. They are typically printed out in the last minute and with minimum review. When these records are then made available to inspectors, they are often incomplete and inaccurate.

In this audio conference, our speaker provides an understanding of offical records, explores different strategies, and explains how to prepare your records for an FDA inspection in a more complete and accurate manner.

Points to Consider when Presenting Documents for an FDA Inspection is being presented by Ronald Eisenwinter, Quality & Regulatory Consultant and airs on Tuesday, February 16, 2010. For more details or to register, please visit our site at www.fxconferences.com

Focus on FDA cGMP Compliance Issues

How do I make sure my facility is ready for an FDA inspection? What exactly is the FDA looking for? It is vitally important for companies within regulated industries to stay abreast of changes in FDA inspections, expectations and actions.

In this event, we will look specifically at the current focus of FDA inspections and the residual effect on actions. We will also examine changes in inspectional emphasis and reveal what inspectors are really looking for.

This audio conference is presented by David Barr of AAC Consulting/Kendle International. To learn more, visit www.fxconferences.com.