Regulatory Readiness: FDA Inspections

The best time to prepare for an FDA inspection is before you need one. This comprehensive session covers inspection triggers, quality management systems, documentation organization for efficient retrieval, staff training, internal audits using practical checklists, and how to respond during actual inspections. As sites adopt AI and technology-driven processes, learn about inspection outcomes for paperless systems, timestamps, and digital workflows. Walk away with your own internal QA checklist and strategies from sites that successfully navigated inspections.