The critical points of USP <1224> and the regulatory requirements required by the USP and FDA. USP <1224> is very specific on what is required for tech transfer of analytical methods as well as the responsibilities of the participating parties.
In this webinar expert speaker Carl Patterson, will discuss the four ways to process analytical method transfers per the USP. Speaker will also go over the FDA guidance document for analytical transfer methods.
This webinar will present fundamental principles of a method transfer, examine different strategies, discuss key factors that would influence the transfer of analytical methods from one site to another. Speaker will also discuss this official USP guidance considering FDA and other regulatory bodies and 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