Transfer of Analytical Methods and Procedures according to USP 1224
Duration: 90 Minutes
This webinar is designed to provide both a regulatory compliant and practical overview of ensuring that the validation of an analytical test method is maintained when transferred to a receiving laboratory. This presentation is intended to provide a current, critical and strategic evaluation of USP <1224> general chapter and FDA guidance on transferring validated test methods to meet both business and regulatory compliance requirements.
Objectives of the Presentation
As an FDA and international regulatory requirement, test method validation must be properly maintained in a receiving laboratory to ensure proper and suitable regulatory compliance. The USP general chapter <1224> provides the official guidance on how to conduct and maintain ‘the validated state’ for a method transfer. This webinar will present and discuss this official USP guidance considering FDA and other regulatory bodies.
Areas Covered
Analytical test methods are at the heart of assuring pharmaceutical product quality and reliability, required by the FDA and international regulatory bodies to verify safety and efficiency. FDA guidelines, aligned with USP and international standards, establish the standard expectations for test method transfer.
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Download Agenda- USP chapter <1224> review
- FDA and International expectations for method transfer
- Approaches for analytical method transfer and the four transfer types
- Enhanced method transfers within a laboratory (e.g., HPLC to UPLC)
- Developing a transfer plan and protocol
- The analytical procedure
- Responsibilities of the transferring and receiving laboratory
- Transfer Report and handling deviations from documented acceptance criteria
As an FDA and international regulatory requirement, test method validation must be properly maintained in a receiving laboratory to ensure proper and suitable regulatory compliance. The USP general chapter <1224> provides the official guidance on how to conduct and maintain ‘the validated state’ for a method transfer. This webinar will present and discuss this official USP guidance considering FDA and other regulatory bodies.
Areas Covered
- Regulatory expectations for method transfer: USP chapter <1224>, FDA and International
- Compliance, failures and warnings
- Approaches for analytical method transfer and the four transfer types
- Enhanced method transfers within a laboratory
- Transfer plan and protocol
- The analytical procedure and acceptance criteria
- Transfer report and handling deviations
- Responsibilities of the transferring and receiving laboratory
- QA/QC managers and personnel
- Laboratory Managers and Supervisors
- Regulatory and Compliance Professionals
- Analysts
- Consultants
- GLP Study Directors & Auditors
- Pharmaceutical Research &Development
- Contract Laboratories
Analytical test methods are at the heart of assuring pharmaceutical product quality and reliability, required by the FDA and international regulatory bodies to verify safety and efficiency. FDA guidelines, aligned with USP and international standards, establish the standard expectations for test method transfer.