Webinar on Transfer of Analytical Methods and Procedures according to USP 1224

Description :

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. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2015 on validation of analytical methods. This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.

For easy implementation, attendees will receive

SOP: Transfer of Analytical Methods

Checklist: Transfer of Analytical Methods and Procedures

Master Plan template and examples: Transfer of Analytical Methods and procedures

Areas Covered in the Session :

FDA and International expectations for method transfer

Examples of FDA warning letters and how to avoid them

The FDA Guidance on method transfer.

The USP chapter <1224>: history, status, future

Four approaches for analytical method transfer and testing

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

Dealing with technology transfer: validation requirements, regulatory notification.

Method transfer from standard HPLC to UHPLC

Most likely failures during method transfer

Handling deviations from documented acceptance criteria

Criteria for transfer waiver (omission of formal transfer)

Method transfer protocol and summary report

Who Will Benefit:

Lab Supervisors and Managers

QA Managers and Personnel

Analysts

Research & Development in Pharmaceutical Industry

Pharmaceutical Quality Control

Contract Laboratories

CROs