
Surviving the Back Room During an FDA Inspection
July 17, 2012
By Christine Park, Founder and Consultant, Christine Park & Associates
During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.
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