AMA on FDA Inspections

  • 27 May 2022
  • 4 replies

Userlevel 5

This week we’ve invited Anne Holland from QA Consulting for an exclusive AMA (ask me anything) session on the topic of the FDA Inspections.

Zoom Link

What challenges are you currently facing as you prepare for your audits and FDA inspections? What feels unclear?

Ask us anything!

Leave your questions in the comment section below - this will give your question the greatest likelihood of being answered.

P.S. There is an interactive video element to this AMA that you can participate in. The link to join the Zoom meeting will be provided on the day of the event!

If you have run into problems, send a message directly to @Etienne and let us know!

4 replies

Greetings! This is Rick L’Amie, I work with Anne Holland, today’s speaker. Anne developed a Do’s and Don’ts checklist for FDA inspections that may be helpful for today’s Q&A.  Here’s a link

Userlevel 2

What are all the things that we are allowed to not show the FDA? It feels like I’ve heard Management Reviews and Internal Audits? Is that right, and are there other things?

Userlevel 3

My question is along the same lines as Owen’s.

How do we protect our IP during an inspection, such as Trade Secrets?

Is it acceptable to have an NDA in place with the FDA, or is this something that is assumed? 

Userlevel 4

In an MDSAP audit, if they can see the Management Review info, how does that “look” in the audit report that is sent to the FDA? Does this create a “backdoor” for the FDA to see that? Thanks!