Verification of Compendial Methods according to the New USP Chapter is a webinar dedicated to
- Inspection and enforcement practices: examples for FDA warning letters
- FDA and international requirements for verification of compendial methods
- USP [1226] requirements
- The background and scope of USP [1226]
- Compendial methods not requiring verification
- What`s new in the second revision?
- Risk based approach for type and extent of testing
- The USP verification process
- Acceptance criteria for testing
- Performance characteristics for verification testing: proven industry examples
- Change vs. adjustment of compendial methods
- How much can compendial methods be changed
- Documenting the verification experiments and results
- Investigating non-performance: root cause and corrective actions
Verification of Compendial Methods according to the New USP Chapter brings together Analysts, Laboratory managers and staff, Regulatory affairs, QA managers and personnel, Documentation department and Training departments.
