Richard Berning

Investigator, International Inspection Cadre

U.S. Food and Drug Administration

Richard Berning has over 14 years of experience as an Investigator with US FDA and has served on the Office of Bioresearch Monitoring’s International Inspection Cadre since its inception in 2018. He has observed a broad spectrum of different electronic recordkeeping systems at clinical investigator, contract research organization, and sponsor sites and aims to educate attendees about the dos and don’ts of electronic record keeping in the modern clinical trial setting.

Session

• FDA Inspection Readiness: Stress Testing Your eSource Documentation