The prospect of a U.S. Food and Drug Administration (FDA) inspection—much like a looming audit from the Internal Revenue Service—is extremely stressful for research site personnel. The good news? The FDA knows this and is making new efforts to reach out to industry to explain the positive side of inspections, says the agency’s David C. Burrow, PharmD, JD, acting director of the Office of Scientific Investigations, which is part of the Office of Compliance within the Center for Drug Evaluation and Research (CDER).
Burrow will present a webinar along with the agency’s Tamika Allen, MS, RN, on November 16, giving fresh insights on the agency’s Bioresearch Monitoring (BIMO) program (View Webinar Details). Allen is senior regulatory operations officer and premarket team lead with the Center for Devices and Radiological Health (CDRH) Division of Bioresearch Monitoring.
“It’s your best opportunity to show the FDA your point of view,” Burrow says of inspections. “It’s your chance to frame the conversation” and help the FDA understand what you did, when you did it, and why, he adds.
A popular speaker at ACRP’s Meeting & Expo in past years, Burrow will give webinar attendees practical tools and tips to take the tension out of an FDA inspection—before, during, and after.
“FDA is not out to get anybody,” Burrow says. Instead, agency inspectors like it “when you do their work for them,” he notes, in the sense that if you can quickly and easily produce information to back your standard operating procedures, you’ll probably have a much nicer inspector experience.
For starters, be as transparent as possible with the inspector. Example: If you don’t have a complete collection of the documents the inspector requests, don’t hold back until you can gather the entire package. Instead, give the inspector what you have and provide a specific timetable for when and how you will provide the final documents.
Another common mistake is to view an inspection as a Form 483. Burrow stresses that an inspection is only a preliminary list of observations; you’ll have plenty of opportunities to address those before any 483 is issued.
“We’re not punitive,” Burrow says. Remember, too, that the overwhelming number of inspections have no “calamitous” consequences. By far, most inspections do not result in a 483, and most uncover only minor issues, Burrow explains.
Finally, don’t forget that the specter of an inspection can produce one unexpected benefit: Making your case for an internal improvement.
“So many times I’ve had someone say to me ‘thank you for saying that,’” because it helps them go back to their boss and better advocate for a change in procedure, Burrow notes.
Webinar: FDA BIMO Compliance and Enforcement of Drugs and Devices
In conjunction with U.S. Food and Drug Administration!
November 16, 2016, 12:00-1:00pm
Webinar attendees will learn best practices for preparing for FDA inspections and key strategies for responding to Form FDA 483s.
Speakers include David Burrow, PharmD, JD, Acting Director of the Office of Scientific Investigations, Center for Drug Evaluation and Research Office of Compliance, FDA, and CDR Tamika Allen, MS, RN, Senior Regulatory Operations Officer and Premarket Team Lead, Center for Devices and Radiological Health Division of Bioresearch Monitoring, FDA.