This webinar focuses on the FDA inspection process, the role of the FDA Form 483, and what it means for a clinical investigator or research site to receive one. The webinar provides important information to help investigators and sites implement remediations and plan for long term success at the site. It concludes by explaining the required actions with respect to the FDA post 483.
Clinical Investigators, Compliance Professionals, Contract Research Organizations (CROs), IRB Members, Research Administrators, Researchers, Sponsors
Meet the Presenter
Theresa A. O’Lonergan, PhD, MA – Velocity Clinical Research
Theresa O’Lonergan received her undergraduate and masters degrees at University of Colorado Boulder. She received her PhD in Clinical Science at the University of Colorado, Anschutz campus. She has helped multiple programs evolve and improve their operations and regulatory compliance. Currently, she is a site director for a large SMO.