QUOTED. 22 January 2020. Steve Niedelman.
Executive Summary
Steve Niedelman of the law firm King & Spalding gave manufacturers a few words of advice when prepping their so-called front rooms, where US FDA investigators do the majority of their work during facility inspections. See what he said here.
“With regard to the front room folks, make sure you have people who can think on their feet and fully understand the nature of the investigator’s questions.” – Steve Niedelman, lead quality systems and compliance consultant, King & Spalding
- Find out more: Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 5)
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