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Managing Data and Documentation for FDA Inspections

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"
  • Start:September 07, 2021
  • End:September 07, 2021
  • Recurring
  • Where:New York, New York,, Not found, Not found, Not found, 10018
  • Phone:N/A
  • Event Type: Other
  • Ticket Price:N/A
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