For sites, understanding the FDA’s expectations during an inspection can help resolve staff apprehensions and provide the landscape for a successful inspection, all while ensuring successful critical post-inspection activities.

Explore the latest strategies for preparing your site for an FDA inspection, and gain insight into a site’s responsibility for assuring GCP compliance as well as the protection of subjects’ rights and safety.

• 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
• Identify site responsibilities to assure the protection of subject rights, safety, and well-being
• Best practices to assure study integrity and GCP compliance

• Presenters

Leslie Paul

Managing Expert, GxP Services, Advarra

Anthea Dransfield

Managing Director, Quality Center of Excellence