Test Article Management and Characterization for Drugs and Devices is a seminar that covers topics such as:
- What are the basic requirements of test article characterization
- What are the recommended procedures for chemical and physical characterization of drugs/devices in safety testing
- How to use GMP test article characterization and the certificate of analysis for a GLP study
- How to manage carry-over from test to control article
- How to characterizing medical devices
- How to define a device test article
- How to document test article usage and distribution
- Stability testing for drugs and devices
Test Article Management and Characterization for Drugs and Devices brings together Management at sponsor companies, Study directors, Laboratory staff, Principal investigators, Device manufacturers and Contract laboratories.
