Live Webinar: Managing Data and Documentation for FDA Inspections When: Tuesday September 7, 2021 - 01:00 PM Duration: 60 Minutes.
Click here to Register Webinar
How should you determine what the FDA has a legal right to see versus what’s discretionary for disclosure? Can the agency request video that was reviewed and referenced in investigation reports? Is your company’s data and documentation organized and ready for your next FDA inspection?
If not, your next inspection could become a scavenger hunt and quickly turn into a difficult experience. But that doesn’t have to be the case.
This webinar will help you get control of your data by using industry best practices and SOPs.
Areas Covered
How to create unique naming conventions to handle masses of data
How to prioritize data that might be requested during an inspection
About pinpoint searching and how to do it
How to develop assessments to gauge the risk of not being able to find a document
The “Top 10” questions to ask about your archival process
What to do when documents are not in the general archives
How to explain missing documents to investigators
Tips for dealing with more than one “original”