As a stakeholder in a research facility the prospect of an inspection by the US Food and Drug Administration (FDA) may elevate your blood pressure and induce feelings of panic. But according to Dr. Harvey Arbit, "the FDA inspection process should go quite smoothly if you're doing everything right." Still nervous? Don't be.
Getting it right means starting off with the right information. Dr. Arbit recommends resources offered by the FDA itself. These include a series of compliance program guidance manuals that provide insight into the FDA inspection program and how FDA personnel are trained.
Continue reading to learn more about compliance program guidance manuals; information on common CI, sponsor, monitor, and IRB deficiencies; as well as other procedures and processes that can be helpful for an FDA inspection.