is being presented by Dr. Ludwig Huber, Director, of LabCompliance and airs on Wednesday, June 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
It is important to maintain the validated state when transferring validated methods between laboratories and sites, so that the receiving laboratory can produce the same reliable results. However, to date there has been no official guidance on what exactly is expected to maintain 'the validated state'. That is changing. The U.S. Pharmacopeia (USP) recently published a proposal for a general chapter <1224>, which will become official with USP 35. Also, the FDA has released an official guidance on how to conduct and document method transfer.
This audio conference presentation looks at FDA and international expectations for method transfer, and discusses how to properly conduct and document a transfer. It explores the various approaches and laboratory responsibilities, and looks at how to develop a transfer plan and pre-approval protocol. The speaker also provides attendees with an understanding of USP and FDA requirements, and provides recommendations and tools for effective implementation.
