USP <1224> Transferring the Method to meet Regulatory Expectations

Duration: 60 Minutes
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.
USP 1224 and the regulatory requirements
Instructor: Carl Patterson
Product ID: 503977
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.

Objectives of the Presentation
  • Regulatory references USP <1224> and FDA Guidance
  • Approaches to analytical method transfer
    • Comparative Testing
    • Co-validation Between Two or More Laboratories
    • Revalidation
    • 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
Why Should you Attend
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.

Who will Benefit
  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Laboratory Managers and Supervisors
  • Research and Development Departments
  • Analysts
  • Consultants
$299
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $379.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $429.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.
View More