Preparing for and Responding to an FDA Inspection
Ellen Liedel-Sargent, Senior Director of Consulting at Advarra, and Robert Romanchuk, IRB Chair at Advarra, outline key activities that can help prepare a research site for a positive inspection experience. They also discuss common Form 483 findings and themes and provide ideas to help sites develop optimal responses to 483s to help diminish the risk of a subsequent Warning Letter.
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