This course includes over twenty-five tools and resources to assist in starting and staying prepared for a regulatory inspection including:

• Links to relevant websites to see common inspection findings
• Inspector’s procedures and ICH GCP Guidelines
• Key Strategies for Inspection Management
• Corrective and preventive action plan outline

Audience:
Primary: Clinical Research Professionals involved in trials subject to regulatory inspections
Secondary: All Clinical Research Personnel

Knowledge level (basic, intermediate, advanced): Basic

Core Competencies:
Ethical and Participant Safety Concerns
Clinical Trial Operations (GCPs)
Study and Site Management
Product Development and Regulation