USP <1224> Transferring the Method to meet Regulatory Expectations

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.

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

FDB2814

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.

membership

JUST RELEASED
SEMINARS
&
WORKSHOPS
 





  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.