Tips on Surviving an FDA Inspection

Jo Sanders, Christchurch Clinical Studies Trust (CCST)

The FDA regularly conducts inspections of clinical trial facilities both domestically and internationally to determine a site’s compliance with regulations and protocol adherence.  Upon completing the inspection the FDA inspector provides an initial verbal classification of the inspection.  This is based on the observations noted during the inspection, the investigator’s report, and FDA District Office supervisory personnel review.

If the inspector finds any objectionable conditions the clinical trials unit is presented with an FDA Form 483, which includes the name of the site, dates of inspection, and lists the observations made by the investigator during the inspection.

In May 2017 Christchurch Clinical Studies Trust was inspected by the FDA.  This presentation will provide some of the background into the inspection and will cover the following topics in relation to the inspection:

• ·       Preparation required by the clinical trial site prior to the Inspector arriving
• ·       Expectations of the FDA prior to the visit and once on site
• ·       The Sponsor’s involvement
• ·       The CRO role in the inspection
• ·       Resource allocation required
• ·       Tips on surviving the inspection