Preparing for an FDA Inspection

Date and time: 
Wed, 04/07/2010 - 12:00pm - 1:00pm
Location: 
UW South Campus Center, Room 316R
Series: ITHS Clinical Research Education Series

Presenter:

Victoria (Tory) Lake, RAC

  • Regulatory Affairs Director, Fred Hutchinson/UW Cancer Consortium  

Objectives:

  • Understanding FDA's bioresearch monitoring (BIMO) program
  • Preparing for an inspection
    • What records must be reviewed and available?
    • What staff must be prepared and available to the inspector?
  • Understanding what to expect during the inspection
  • Guidelines for interacting with the inspector
  • Understanding what happens after the inspection

A link to the recorded webcast along with a copy of the slide presentation and handouts will be available below by the day of the lecture.