This practical course prepares clinical research sites for an FDA inspection. It provides instruction on responding to a notification of inspection, organizing staff and records, conducting research during the inspection, and managing opening, daily debriefing, and closeout meetings. The course places an emphasis on constant vigilance in maintaining inspection readiness to minimize the likelihood of receiving observations and warning letters.
Language Availability: English
Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Investigators, Laboratory Personnel, Postdocs, Research Administrators, Research Assistants, Sponsors, Students, Study Sites
Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99.39 per person
