Why Should You Attend:
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'. This has changed since the USP has published the final version of the general chapter < 1224>. Also the FDA has released an official guidance on how to conduct and document method transfer and FDA has been starting to enforce the new USP chapter. Now it is a good time to learn how to conduct and document method transfer.
This webinar will give a good understanding of USP and FDA requirements for transfer of analytical methods and provide recommendations and tools for effective implementation.
Areas covered in this webinar:
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 < 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.
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'. This has changed since the USP has published the final version of the general chapter < 1224>. Also the FDA has released an official guidance on how to conduct and document method transfer and FDA has been starting to enforce the new USP chapter. Now it is a good time to learn how to conduct and document method transfer.
This webinar will give a good understanding of USP and FDA requirements for transfer of analytical methods and provide recommendations and tools for effective implementation.
Areas covered in this webinar:
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 < 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.
