Imagine sitting down over coffee with the FDA investigators who may perform your next inspection and chatting about their work. What would you learn?
Well, pour yourself a cup and prepare to find out as you watch Face to Face with FDA Investigators: A Candid Conversation. Seven current and former FDA investigators field questions from an audience of drug and device manufacturers just like you, and the answers they give will surprise you.
Take a look …
The video opens with a brief presentation by respected Baltimore District Office Supervisor Lori Lawless, who offers an easy-to-understand and frank overview of how FDA investigators prepare for and conduct inspections, including how an investigator organizes his or her inspection plan; the best way to respond to investigators’ observations, both during and after the inspection; the real meaning of each of the three terms the FDA uses to classify inspections—No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI); and much more.
Then, homing in on her specialty — device inspections — Lawless tells:
The video goes on to feature six other current or former FDAers discuss questions you may have been afraid to ask. Such as:
Enhance and inform your inspections training with the ground-breaking Face to Face with FDA Investigators: A Candid Conversation. It's the best training purchase you'll make this year.
You also receive a collection of invaluable resources, including Chapter 5 of the IOM: Establishment Inspections, a copy of the QSIT manual, sample FDA inspection forms, 2 FDAnews management reports and printable presentation slides in note-taking format.
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