Why have dozens of companies received warning letters for laboratory control and out-of-specification violations? Improper analytical method validation testing.

And a warning letter isn't the only consequence of a poor validation system. False passes, poor reducibility, late shipments and production disruptions are all risks you face without a proper validation process in place.

Analytical Method Validation: An Interactive Workshop to Assure Your Test Results Pass FDA Scrutiny provides insight into what the FDA is looking for and how to avoid warning letters. From start to finish, you'll have the how-tos of running analytical method validation, including the generation and compilation of data reports.

You'll not only get step-by-step instruction on executing an analytical method validation, but you'll have the chance to perform your own method validation summary report and share the results with your peers, as well as Michele Piepoli, your expert instructor.

You'll come away from this new interactive workshop fully prepared to write a comprehensive analytical method validation summary report that will pass FDA muster.

“Michele is an excellent speaker who is able to keep meeting subject matter focused, interesting and bring theory to reality.” Tim Urschel Director, Regulatory Affairs and Quality Assurance Transave Inc.