Verification of Compendial Methods according to the Revised USP Chapter 1226

July 30, 2012 - PRLog -- Why to 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. The industry is unsure how to do ths, butFDA inspectors get out and write 483's and warning letters related to 1226. Now USP has announced to come out with a new revision of OSP 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
)
                   
And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* SOPs: Verification of Compendial Methods
* SOP: Change vs. Adjustments of Compendial Methods
* SOP: Validation of Chromatographic Methods
* Checklist: Verification of Compendial Methods
* Validation of Analytical Methods and Procedures
* Case Studies; Verification of Compendial methods and procedures
* Reference Article: Validation of Standard Methods
* USP Presentation with test examples: Verification of Compendial Proceduresl


Date:  Recorded, available at any time
Location: Online, worldwide

Who should attend
*  Laboratory managers and staff
*  Analysts
*  QA managers and personnel
*  Regulatory affairs
*  Training departments
*  Documentation department
*  Consultants


Weblink:  http://www.labcompliance.com/seminars/audio/296/default.aspx

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, API Manufactuer, FDA, Change Control