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

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.

Hand-Outs:

For easy implementation, attendees will receive

• SOP: Verification of Compendial Methods
• Checklist: - Verification of Compendial Methods
• Case Studies; Verification of Compendial methods and Procedures

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

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?