USP <1224> Transferring the Method to meet Regulatory Expectations
February 13, 2019 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:4169154458
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.