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Implementing the New USP Chapter for Analytical Method Transfer
This seminar will discuss strategies and present examples on how to transfer analytical methods most efficiently
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has approved a new general chapter for official use in May 2012 with USP 35. Now it is a good time to learn how to conduct and document transfer of analytical procedures according to USP and FDA expectations.
Areas Covered in the Seminar:
* FDA and International expectations for method transfer
* Examples of FDA warning letters and how to avoid them
* The FDA Guidance on method transfer.
* The new USP chapter : history, status, content
* Four approaches for analytical method transfer and testing
* Selecting the best approach
* Responsibilities of the transferring and receiving laboratory
* Developing a transfer plan and a pre-approval protocol
* Conducting comparative studies
* Criteria and approaches for risk based testing: what, when, how much?
* The importance and selection of acceptance criteria
* Method transfer from standard HPLC to UHPLC
* Handling deviations from documented acceptance criteria
* Method transfer protocol and summary report
Date: Recorded Seminar - Available at any time
Location: Online, worldwide
Who should attend
* Everybody involved in method transfer
* QA managers and personnel
* Analysts and lab managers
* Validation specialists
* Training departments
* Documentation department
Category: Pharmaceutical, FDA, USP, validation, laboratories
Presenter: Dr. Ludwig Huber
Page Updated Last on: Sep 17, 2012