Verification of Compendial Methods According To the Revised USP Chapter
Webinar/Online
This seminar will discuss the new risk-based approach and attendees will get get real world case studies for testing.
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. The industry is unsure how to do ths, but FDA inspectors get out and write 483's and warning letters related to the chapter. Now USP has announced to come out with a new revision of USP 1226 using the risk based approach for the type and extend of testing. Because there are no further guidelines there are still many questions.
Areas Covered in the Seminar:
FDA and international requirements for verification of compendial methods
Inspection and enforcement practices: examples for recent FDA warning letters
The background and scope of USP 1226
What's new in the second revision?
Compendial methods not requiring verification
The USP verification proces
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
(Courtesy of http://www.labcompliance.com/seminars/audio/)
Thu, Aug 30, 2012 - Thu, Aug 30, 2012 (11.00 – 12.00 a.m. EDT)
Webinar/Online
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