Preparing for an FDA Inspection

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.