This introductory GCP and Auditing course is designed to provide a working understanding of Good Clinical Practices (GCP) regulations and the GCP quality assurance audit process. The course presents a unique perspective on GCP and the audit process allowing the attendee to understand and integrate the role of monitoring and oversight of clinical trials with the audit process.

KEY TOPICS
•Good Clinical Practices (GCP)
•Role Of GCP In Clinical Research
•Regulatory Requirements Specific to GCP
•Data Requirements Specific to GCP
•GCP Audits/Inspections
•The Quality Assurance Audit Process as a Method of Ensuring Data Quality.