There aren’t many things that can cause a compliance manager, study coordinator, research administrator, investigator, or clinical trials team to hyperventilate, lose sleep over, or stress more about than the words, “This is the US Food and Drug Administration (FDA) and we are coming to inspect your study.” The FDA inspecting your site can be daunting, but if you are prepared, it can minimize your team’s angst prior to the visit. This webinar will explain the FDA’s inspection process, ways to prepare for the visit, not only after the call, but proactively so that you are ready for the call any day. There are ways to design your processes so that FDA regulations and Good Clinical Practice (GCP) elements are common place. This will help you be ready for the day that call comes and avoid the last-minute corrections and work required to have files and binders ready, avoiding late-night preparation for FDA visits.
- Describe the FDA inspection process for clinical trials.
- Describe Good Clinical Practice (GCP) elements necessary for clinical trials.
- Outline processes that can provide day-to-day efforts that will enhance clinical trials programs, proactively preparing files for FDA inspections.
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