Verification of Compendial Methods According to the Revised USP Chapter <1226>

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. 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 has announced to 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.

Who Will Benefit:

• Analysts
• Lab Supervisors and Managers
• QA managers and personnel
• Consultants
• Teacher