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Preparing for and Responding to an FDA Inspection

Thursday, January 31
Presentation: 2:00-3:00pm ET
Q&A: 3:00-3:15pm ET

An FDA inspection of a research site can occur at any time, and preparation is critical to "surviving" the inspection. By understanding what the agency typically looks for in its inspections, sites can make sure all documentation is ready for review and all staff are properly trained to interact with the inspector. Proactive preparation can help ensure the inspection goes as smoothly as possible, avoiding burdensome follow-up and the possibility of an FDA Form 483.

However, receiving an FDA Form 483 isn't uncommon--each year, roughly 250 FDA Bioresearch Monitoring Program (BIMO) inspections of clinical investigators result in the issuance of an FDA Form 483 with findings. After receiving notice of an objectionable condition at a research site, it's up to research site staff to respond adequately. Failure to do so can escalate the FDA's concern to a Warning Letter, which can have devastating consequences. The key to avoiding a Warning Letter is a timely and robust response to the initial 483 that outlines a corrective action plan and sets forth its implementation expeditiously.

In this webinar, Robert Romanchuk, IRB Chair at Advarra, and Ellen Liedel-Sargent, Senior Director of Consulting at Advarra, will outline key activities that can help prepare a research site for a positive inspection experience. They will also discuss common Form 483 findings and themes and provide ideas to help sites develop optimal responses to 483s to help diminish the risk of a subsequent Warning Letter.

Presentation Objectives
Following this free webinar, attendees will be able to:

  • Prepare and plan effectively for an FDA inspection at a research site
  • Develop responses to 483s that mitigate risk of a subsequent Warning Letter
  • Prepare CAPAs that are substantive and robust

Who Should Attend
  • Principal investigators
  • Research site coordinators and staff
  • Quality assurance professionals
  • Other research professionals involved in regulatory inspections and responding to inspection findings

Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.


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