Face to Face with FDA Investigators: A Candid Conversation
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:
- How the FDA decides which manufacturers to inspect
- How the Quality Systems Inspectional Technique (QSIT) drives an inspection
- How devicemakers can annotate their 483s
- The resources the FDA provides to help devicemakers understand the process
The video goes on to feature six other current or former FDAers discuss questions you may have been afraid to ask. Such as:
- Is an investigator entitled to see a company’s internal audit reports?
- Should I hire a former FDA-er as an inspection consultant?
- What should I do while the investigator has to wait for document retrieval?
- Will investigators view my website and even my YouTube channel while preparing for my inspection?
- Do investigators have to ask permission before taking photographs?
- And much more
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.