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

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 and the first revision of USP <1226> did not have specific recommendations. Now USP has announced to come out with a new revision using the risk based approach for the type and extend of testing. Because there are no further guidelines there are still many questions.

Key Questions are:

What are FDA and international requirements for compendial methods?
What and how much should be tested?
How to use the risk based approach?
Is system suitability testing enough?
Do all compendial routine methods require verification?
When could just system suitability testing be enough?
Should we verify all performance characteristics?
How much can we deviate from the compendial method without the need for a full revalidation?
What to do if I the compendial procedure can not be verified?
How frequently should compendial methods be re-verified?
What if our equipment was not included in the USP method validation experiments

How does the this audio seminar help:
Answers will be presented by Dr. Ludwig Huber in a new interactive audio 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 SOPs, real world case studies for testing, worksheets, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

FDA and international requirements for verification of compendial methods
Inspection and enforcement practices: examples for FDA warning letters
The background and scope of USP <1226>
USP <1226> requirements
What's new in the second revision?
Compendial methods not requiring verification
The USP verification process
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

And for easy and instant implementation:
download 10+ documents from special seminar website
SOPs:
- Verification of Compendial Methods
- Change vs. Adjustments of Compendial Methods
- Validation of Chromatographic Methods
Checklist:
- Verification of Compendial Methods
- Validation of Analytical Methods and Procedures
Reference Article
- Validation of Standard Methods
- Validation of HPLC Methods
- Validation of analytical methods: review and procedures
Warning letters and/or Inspectional observations related to verification of compendial methods
USP Presentation with test examples: Verification of Compendial Procedures
Proposed revision of the USP <1226> (link)
FDA Guidance
- Analytical procedures and methods validation
ICH Guidelines for the Industry
- Text on Validation of Analytical Procedures
- Validation of Analytical Procedures: Methodology

Who should attend?

Laboratory managers and staff
Analysts
QA managers and personnel
Regulatory affairs
Training departments
Documentation department