From Simulation to Success: Stress Testing Your Inspection Readiness

Preparing for FDA inspections can be daunting, but mock inspections offer a powerful tool to ensure compliance and readiness.

By simulating real-world inspection scenarios, organizations can address vulnerabilities proactively, develop robust corrective actions, and foster a culture of continuous improvement. Join Advarra’s GxP compliance expert as he outlines key compliance focus areas and discusses strategies to integrate inspection findings into long-term quality management.

Participants will gain actionable insights into how mock inspections can identify potential gaps in processes, documentation, and adherence to regulatory standards.

Learning Objectives:

• Understand the elements and expectations of FDA and BIMO inspections
• Equip attendees with the knowledge to confidently face FDA scrutiny and drive success through preparedness.
• Identify strategies for improving internal quality structures to better support regulatory inspections
• Explain why preparation and simulations are critical to a successful BIMO inspection
• Explore refresher tips for large pharma on executing a successful inspection

• Presenter

Jeremy Allard

Managing Director, GxP Services