A regulatory Inspector just arrived at your company to conduct a Good Clinical Practices (GCP) inspection. Is your organization prepared? What will they want to look at? What is the best way to manage the inspection? Are there any post-inspection activities? If so, what are they?
All regulatory agencies conduct GCP inspections of sponsors, contract research organizations (CROs), study sites, and laboratories. With a focus on the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) Inspection activities, this webinar will discuss the different types of inspections, who can be inspected, what can be inspected, and when you can anticipate a regulatory audit. Recommendations for preparing your organization for a regulatory inspection as well as inspection “do’s and don’ts” will be presented. Some common inspection findings and their origin will be discussed. Recommendations for inspection follow-up activities will be presented with actionable tools to use after you have completed the course.
At the completion of this session, you will be able to:
- Prepare your staff and processes for audit readiness
- Define areas of risk and correct them
- Learn what to say – and what not to say – during an inspection
- Set up your inspection plan and activities
- Execute proper corrective actions (CAPA) for findings, and learn how to respond to observations