Verification of Compendial Methods-USP <1226>-Why and How

Duration: 75 Minutes
This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and also provide recommendations and tools for its effective implementation.
Compendial Methods
Instructor: Dr. Ludwig Huber
Product ID: 500958

Why Should you Attend
Compendial methods such as USP and EP standards are validated by the organizations that have developed and published this 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 did come out with a new revision using the risk based approach for the type and extend of testing.

Objectives of the Presentation
  • FDA and international requirements for verification of compendial methods
  • The background and scope of USP <1226>
  • What's new in the second revision?
  • Compendial methods not requiring verification
  • 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
Who can Benefit
  • Analysts
  • Lab Supervisors and Managers
  • QA Managers and Personnel
  • Consultants
  • Teacher
$375
Recorded Session for one participant
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ludwig Huber, Ph.D., is the director of Lab compliance, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.


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