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.

Join us to 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.

Learning Objectives:

  • 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

Presented By:

Leslie Paul – Director, Quality Center of Excellence, Advarra Consulting

Anthea Dransfield – Managing Director, Quality Center of Excellence, Advarra Consulting

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