Organizing Data and Document Archives Virtual Conference Agenda
10:00 a.m. – 10:15 a.m. |
Introduction to the Virtual Conference, Chairperson |
10:15 a.m. – 11:45 a.m. |
Best Practices for Dealing with Raw Data and Data Query Requests from FDA Investigators Attendees will learn:
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11:45 a.m. – 12:00 p.m. |
Break |
12:00 p.m. – 1:00 p.m. |
Focus on Clinical and Laboratory Data: Practical Steps to Organizing and Presenting Analysis Data Attendees will learn:
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1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 3:00 p.m. |
Hold on a Minute: Understanding the Scope of — and Limitations on — What Documents the FDA Can Ask for During an Inspection Attendees will learn:
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3:00 p.m. – 3:15 p.m. |
Closing Comments and Adjournment, Chairperson |