USP <1224> Transferring the Method to meet Regulatory Expectations
Duration : 60 Minutes
Carl Patterson, MS, SSGB, SSBB,
Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However Read more
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 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.
Course Objectives:
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.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Compliance Departments
• Laboratory Managers and Supervisors
• Research and Development Departments
• Analysts
• Consultants
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
