Sponsors: Are Your Sites Ready for an FDA Inspection?

For sponsors and sites, developing a clear understanding of the expectations in planning and hosting an inspection can provide the landscape for a successful inspection, all while ensuring successful critical post-inspection activities.

Explore the latest strategies for preparing your sites for a health authority inspection. How do sites integrate sponsor-provided technology and current data management best practices to avoid costly study delays? Register now to gain insight into a site’s responsibility for assuring both good clinical practice (GCP) compliance and the protection of subjects’ rights and safety.

Learning Objectives:

• Gain valuable insights for integrating sponsor-provided technology to become inspection ready
• Learn successful site-specific strategies for a proactive approach to FDA inspections
• Gain an in-depth understanding of an FDA inspection and post-inspection activities for sites and sponsors
• Understand best practices to assure study integrity and GCP compliance

• Presenters

Leslie Paul

Managing Expert, GxP Services, Advarra

Stuart Cotter

Vice President, Product Management, Advarra