Test Article Management and Characterization for Drugs and Devices

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.

Areas Covered in the Seminar:

• What are the recommended procedures for chemical and physical characterization of drugs/devices in safety testing.
• What are the basic requirements of test article characterization.
• How to manage carry-over from test to control article
• How to use GMP test article characterization and the certificate of analysis for a GLP study
• How to define a device test article
• How to characterizing medical devices
• Stability testing for drugs and devices
• How to document test article usage and distribution