Topics
- 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
Who should Attend
Management at sponsor companies, Study directors, Laboratory staff, Principal investigators, Device manufacturers and Contract laboratories.
