The Cutting Edge of Medical Technology Content, Community & Collaboration
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published a proposal for a general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. The new USP chapter will become official with USP 35. Now it is a good time to learn how to conduct and document method transfer. This seminar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.