ComplianceOnline

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

Instructor: Dr. Ludwig Huber
Product ID: 700456
Training Level: Advanced
  • Duration: 75 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and provide recommendations and tools for effective implementation.

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
Who Will Benefit:
  • Analysts
  • Lab Supervisors and Managers
  • QA managers and personnel
  • Consultants
  • Teacher

Instructor Profile:

Dr. Ludwig Huber, Ph.D., is Director of Labcompliance and editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. Dr. Huber is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. He has given more than 200 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. For more information, visit Dr. Huber’s website: www.ludwig-huber.com

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews Write review

Thank you for the seminar today. It was very informative.
- Anonymous

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