USP <1224> Transferring the Method to meet Regulatory Expectations

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.

Areas Covered in the Session :

• 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

Who Should Attend:

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

Course Director: CARL PATTERSON ‎

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, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse. To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector. Recently, he is in the process of creating webinars so he can share pertinent information about pharmaceutical manufacturing from a microbiological perspective. Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.