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Recorded Webinar
Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
The presentation will cover the following areas:
- Does the FDA call in advance or just show up at my door?
- Where do I let the inspector go?
- Do I give them a tour?
- What should I let them see?
- Who should I let them talk to?
- Are they ever going to leave?
Who should attend
Anyone who is interested in learning more on FDA Inspection
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