Being ready for an FDA inspection requires coordination, organization, and preparation by investigators, research sites, sponsor/CROs, and IRBs. This course prepares investigators and sites for an FDA Bioresearch Monitoring Program (BIMO) inspection by reviewing the concrete steps to take before, during, and after the inspection.
The FDA Inspections course explains the inspection process and terminology, and provides strategies to prepare for an inspection including the review of regulatory guidance and manuals (such as the Compliance Program Guidance Manual [CPGM]), actively preparing the study team, and performing mock inspections. Reviews the importance of the Form FDA 482 and how to coordinate and communicate during an inspection as well as next steps and strategies for responding to a Form FDA 483. The course discusses how to create a CAPA plan to address findings.
Language Availability: English
Suggested Audiences: Clinical Investigators, Key Study Personnel, Principal Investigators, Research Managers, Research Site Representatives, Researchers, Sponsors/CROs, Sub-investigators
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 per person