USP [1224] Transferring the Method to meet Regulatory Expectations 2019

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.

Topics

• 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

Who should Attend

• Quality Assurance Departments
• Regulatory Affairs Departments
• Quality Control Departments
• Laboratory Managers and Supervisors
• Compliance Departments
• Analysts
• Research and Development Departments
• Consultants