USP [1224] Transferring the Method to meet Regulatory Expectations 2019 is an event dedicated to the critical points of USP and the regulatory requirements required by the USP and FDA.
USP [1224] Transferring the Method to meet Regulatory Expectations 2019 covers topics such as:
- Regulatory references USP and FDA Guidance
- Responsibilities of participating parties
- Approaches to analytical method transfer o Comparative Testing o Co-validation Between Two or More Laboratories o Revalidation o Transfer Waiver
- Elements of a complete method validation
- Effective planning, execution, and documentation of method transfer
- Requirements as outlined in USP
- Regulatory requirements for analytical method transfer
- Planning and executing the analytical transfer validation
- Requirements as outlined in FDA Guidance document
- Closing the loop on the transfer process
USP [1224] Transferring the Method to meet Regulatory Expectations 2019 intended for:
- Quality Assurance Departments
- Regulatory Affairs Departments
- Quality Control Departments
- Laboratory Managers and Supervisors
- Compliance Departments
- Analysts
- Research and Development Departments
- Consultants
