Verification of Compendial Methods According to the Revised USP Chapter <1226>
Instructor:
Dr. Ludwig Huber
Product ID: 700456
Training Level: Advanced
- Duration: 75 Min
Why Should You Attend:
Compendial methods such as USP and EP standards are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example, 21 CFR 211.194 (a) states: The suitability of all testing methods used shall be verified under actual conditions of use. However, the FDA does not give any further guidance on what, when and how. And the first revision of USP <1226> did not have specific recommendations. But FDA inspectors go out and write 483's and warning letters related to <1226>. Now USP did come out with a new revision using the risk based approach for the type and extend of testing.
This webinar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.
Learning Objectives:
- FDA and international requirements for verification of compendial methods
- The background and scope of USP <1226>
- What's new in the second revision?
- Compendial methods not requiring verification
- USP <1226> requirements for verification and testing
- Risk based approach for type and extent of testing
- Performance characteristics for verification testing: proven industry examples
- Acceptance criteria for testing
- How much can compendial methods be changed
- Change vs. adjustment of compendial methods
- Investigating non-performance: root cause and corrective actions
- Documenting the verification experiments and results
- Analysts
- Lab Supervisors and Managers
- QA managers and personnel
- Consultants
- Teacher
Dr. Ludwig Huber, Ph.D., is Director of Labcompliance and editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. Dr. Huber is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. He has given more than 200 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. For more information, visit Dr. Huber’s website: www.ludwig-huber.com
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