2011 - Verification of Compendial Procedures According to the Updated USP Chapter 1226

Why to 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 to test. And the first revision of USP <1226> did not have specific recommendations. But FDA inspectors got out and write 483's and warning letters. Now USP has announced to come out with a new revision by end
of 2011 using the risk based approach for the type and extend of testing.

Answers will be presented by Dr. Ludwig Huber in a new interactive on-line seminar. During the seminar, the speaker will present the requirements for method verification and give practical recommendations. After the seminar, an extensive list of reference material like the new USP draft chapter (link, SOPs, real world case studies for testing, worksheets, templates and examples will help immediate and cost effective implementation.

Contents:
* FDA and international requirements for verification of USP methods
* Inspection and enforcement practices: examples for FDA warning letters and 483's
* The background and scope of USP <1226>
* USP <1226> requirements and what's new in the second revision
* Compendial methods not requiring verification
* The USP verification process: step-by-step
* Risk based approach for type and extent of testing
* Performance characteristics for verification testing: proven industry examples
* Acceptance criteria for testing
* How much can USP methods be changed: Change vs. adjustment of compendial methods
* Documenting the verification experiments and results

Date: September 1,2011

Who should attend
* Laboratory managers and staff
* Analysts
* QA managers and personnel
* Quality control unit staff
* Regulatory affairs
* Training departments
* Documentation department