Verification of Compendial Methods-FDA Regulations

Website http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500958?expDate=Sep9_2015_Verifica | Edit Freely

Category method validation and development, compendial methods, fda regulations, usp method validation, method validation fda, usp compendial methods

Deadline: September 08, 2015 | Date: September 09, 2015

Venue/Country: online Webinar, U.S.A

Updated: 2015-08-28 14:03:19 (GMT+9)

Call For Papers - CFP

Instructor: Dr. Ludwig Huber

Product ID: 500958

Description

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

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 did not have specific recommendations. But FDA inspectors go out and write 483's and warning letters related to . 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

What's new in the second revision?

Compendial methods not requiring verification

USP 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

For Registration-

http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500958?expDate=Sep9_2015_VerificationOfCompedendialMethods=Channel=ourglocal

Note : Use coupon code 1371 and get 10% off on Registration