Test Article Management and Characterization for Drugs and Devices (Laboratory Complianc)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Sep 11, 2012 End Date/Time: Sep 11, 2012
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This 90-minute webinar will clarify your confusion about Test Article Characterization for GLP drug studies. You will learn the correct way to use GMP characterization data in a GLP study, understand how to characterize a medical device as a test article, learn the common mistakes made in test article characterization and the basic requirements for drug and device stability testing.

Why Should You Attend:

The presentation will begin with a review of GLP requirements for test and control article characterization, regardless of whether the article is a drug or device. It will address the study director's responsibilities and sponsor responsibilities in test article characterization. Attendees will learn the best practices for managing GMP characterizations, stability, and certificates of analysis. Special attention is given to the testing that must be performed to show that no test material carried over into control materials. Carryover has become one of FDA’s target areas in recent years because of the serious effect it has on drug safety results. The presentation treats carryover as a special topic in test article/control article characterization. The presenter also emphasizes the importance of control article characterization.


Online Event
2600 E. Bayshore Road
Palo Alto
United States