On August 19, 2020, American University of Health Sciences hosted the 2020 ACRP virtual event held through ZOOM, in accordance with the Southern California chapter of the ACRP. With locations in more than 70 countries worldwide, ACRP’s members work together in a variety of practice settings, roles, and specialty areas, with a wide range of experience in clinical research. The Southern California chapter is proudly among these many locations to inform the public about the latest regulatory developments, news, and trends that impact and involve clinical trials.

The event, “Knock, Knock, FDA is Here; Be Prepared for a Regulatory Inspection” was a two-hour virtual event that discussed regulatory inspections from the United States Food & Drug Administration. The guest speaker for this event was Mr. Eric S. Pittman, who is the current Program Division Director for the FDA/ORA Bioresearch Monitoring Program Division II (BIMO-W) which covers from Detroit, MI to Hawaii. He works with a talented and highly skilled group of supervisors, field investigators, and administrative staff to ensure that research subjects are protected, and the data used to support FDA decisions are accurate and reliable. Mr. Pittman is currently stationed in Chicago, IL near Chicago’s Union Station.

Points of discussion during this event highlighted important protocols to take during FDA visitations, especially in the field of healthcare. Healthcare professionals in the areas of clinical research, nursing, pharmacy, and more are subjected to these regulatory visitations and procedures from the FDA. In order to become familiar with the policies and prepare for this course of action, the event welcomed healthcare professionals from a variety of fields. AUHS is proud of hosting this event and many more upcoming quarterly events regarding the FDA, which will be:

  • Keeping Informed and Working with the FDA
  • Quality Management Systems in GCPs
  • Metadata

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