Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
Date & Time
Friday, November 18, 2022, 10:00 AM - 10:45 AM

Your documents may not be as organized as you think they are. Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack?

Paper documents unscanned. Naming conventions that don’t make sense. Emails as GXP documentation. Poor communication with the vendors that generate your data. Nonfunctional (or nonexistent) SOPs. Documents missing altogether. Yes, data retrieval is in a sorry state at far too many drug, device, biologics and clinical trials companies.

But your next inspection day need not become scavenger hunt day. Create effective new SOPs for electronic document management or improve existing ones. This session will show you the tools you need to make it easy.

David Chesney
Location Name
Gallery 2-3