ComplianceOnline, Online Event
2013-10-10
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 did 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: - 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
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