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
Presented By
Managing Director, GxP Services
Advarra Consulting
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Assistant Clinical Professor, Internal Medicine and Pediatrics
Conventus Site Medical Director for UBMD
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DATE: October 15, 2024
TIME: 1:00 pm ET | 10:00 am PT
DURATION: 1 hour