UNC NRP 2015 Fall Event

What You Should Know About FDA Audits Presented by The UNC Network for Research Professionals (NRP) and the NC TraCS Institute

When Nov 06, 2015
from 12:00 PM to 02:30 PM
Where MBRB Auditorium G202
Contact Name
Contact Phone 919.966.0568
Attendees All University Research Staff Are Welcome to Attend
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This course will provide a brief overview of the US Food and Drug Administration’s (FDA) Inspection program form Biomedical Research and provide suggestions for preparing and responding to an FDA audit.

Presentation Objectives:

  • Bioresearch Monitoring (BIMO) Program Overview
  • Introduce CRAs to BIMO program and FDA inspections
  • How to prepare for FDA Inspection – what we will ask for up front and need available during the inspection
  • What to expect during FDA Inspection – copies of documents, access to electronic databases,etc.
  • We’ve been audited!! Now what?! – FDA requirements, receiving and responding to FDA 483, etc.

More information about this event…