Virginia Chapter: Confident FDA Audit Navigation
Event Description:
FDA takes its responsibility seriously to ensure the medical products we use and rely on meet rigorous standards for quality, safety, and effectiveness. The agency uses risk-based approaches to identify investigator sites for inspections. An inspection is a careful, critical, official onsite examination to determine its compliance with federal law.
As of 24July24, FDA Bioresearch Monitoring (BIMO) had conducted 783 inspections for FY 2023 of investigators, institutional review boards (IRBs), sponsors, clinical research organizations (CROs) and sponsor-investigators.
BIMO conducted 666 inspections of clinical investigators. Of the inspections, only 9 resulted in a Official Action Indicated (QAI) adn 136 resulted in Voluntary Action Indicated (VAI).
Speaker: Hilary Hedrick, MEd
Event Agenda:
12:00 - 12:45 p.m., ET: Presentation
12:45 - 1:00 p.m., ET: Q&A
Event Learning Objectives:
- Describe the key components of FDA inspection preparation
- Organize essential regulatory documents according to FDA standards
- Develop preventative strategies for common inspection findings
Registration Information:
- Chapter Member: $0
- ACRP Member: $15
- Non-Member: $30
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.