When transferring validated methods between laboratories and sites, their validated states must be maintained to safeguard the exact consistent results in the receiving laboratory. The critical points of USP <1224> are very specific on the requirements for technology transfer of analytical methods as well as the responsibilities of all participating parties. This must be in accordance with the regulatory requirements required by the USP and FDA.
This webinar delivered by industry expert speaker Carl Patterson, will deliberate the four systems to process analytical method transfers as per the USP guidance. This webinar will also review the FDA guidance document for analytical transfer methods.
Fundamental principles of a method transfer will be discussed. We will also examine the different strategies available; as well as discuss key factors that would influence the transfer of analytical methods from one site to another. Mr. Patterson will also discuss this official USP guidance in consideration of the FDA and other regulatory bodies. He will also go over how to conduct and maintain ‘the validated state’ for a method transfer.
- Regulatory references USP <1224> and FDA Guidance
- Approaches to analytical method transfer o Comparative Testing o Co-validation Between Two or More Laboratories o Revalidation o Transfer Waiver
- Responsibilities of participating parties
- Effective planning, execution, and documentation of method transfer
- Elements of a complete method validation
- Regulatory requirements for analytical method transfer
- Requirements as outlined in USP <1224>
- Requirements as outlined in FDA Guidance document
- Planning and executing the analytical transfer validation
- Closing the loop on the transfer process
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Compliance Departments
- Laboratory Managers and Supervisors
- Research and Development Departments