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Subscribe NewsletterTransfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation
Product Id
:
600171
Overview: 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 have not been official guidance on what exactly is expected to maintain 'the validated state'. Now the USP is preparing for a general chapter and the FDA has released an official guidance on how to conduct and document method transfer. The guide has been developed for medicated feed assays but the principles can be applied to other methods. Now it is a good time to learn how to conduct and document method transfer for FDA compliance.
So far there have not been official guidance on what exactly is expected to maintain 'the validated state'. Now the USP is preparing for a general chapter and the FDA has released an official guidance on how to conduct and document method transfer. The guide has been developed for medicated feed assays but the principles can be applied to other methods. Now it is a good time to learn how to conduct and document method transfer for FDA compliance.
Areas Covered in the Session:
- FDA and International regulations for method transfer
- Examples of FDA warning letters and how to avoid them
- The FDA Guidance on method transfer.
- The proposal for a new USP chapter
- Developing a strategy for analytical method transfer
- Developing an SOP for method transfer
- Responsibilities of the transferring and receiving laboratory
- Developing a transfer plan: contents and approval
- The importance of acceptance criteria
- Conducting comparative studies
- Dealing with technology transfer: validation requirements, regulatory notification.
- Method transfer from standard HPLC to (ultra)fast HPLC
- 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:
- QC managers and personnel
- QA managers and personnel
- Analysts and lab managers
- Validation groups
- Validation professionals
- Training departments
- Documentation department
- Consultants