Laboratory Compliance 2012 - Verification of Compendial Methods According to the Revised USP Chapter

This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and provide recommendations and tools for effective implementation.

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.

Learning Objectives:
- What are FDA and international requirements for compendial methods?
- What and how much should be tested?
- How to use the risk based approach?
- Is system suitability testing enough?
- Do all compendial routine methods require verification?
- When could just system suitability testing be enough?
- Should we verify all performance characteristics?
- How much can we deviate from the compendial method without the need for a full revalidation?
- What to do if the compendial procedure cannot be verified?
- How frequently should compendial methods be re-verified?
- What if our equipment was not included in the USP method validation experiments.