Analytical Method Transfer
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*Kathy Lee, Food and Drug Administration 

Keywords: Analytical, method transfer

Validated analytical methods are transferred from originating laboratories to new laboratories by companies’ everyday. Often, there is a lack of understanding of the FDA’s expectations for an acceptable method transfer. This talk will discuss the expectations for method transfers, including the method transfer protocol and final study report. In addition, examples of acceptable and unacceptable method transfers submitted to the FDA will be provided.