2025 - Mastering Inspection Readiness for FDA’s AI Tool Elsa

AI is changing how the FDA works, and how sponsors need to prepare.
As AI reshapes the regulatory landscape, sponsors face new challenges in maintaining inspection readiness. The FDA’s forthcoming implementation of Elsa, its new AI-driven inspection tool, signals a transformative shift in how inspections and quality oversight will be conducted. At the same time, sponsors are under increasing pressure to do more with less, navigating tighter budgets, leaner quality teams and complex compliance expectations.
In this webinar, the featured speakers will unpack what the rise of AI means for inspection preparedness. They’ll explore how Elsa may change the inspection process, what FDA reviewers may look for in AI-assisted audits and how sponsors can proactively assess, strengthen and document their quality systems to stay inspection-ready in this new environment.
Register for this webinar to learn how inspection readiness can evolve to meet the demands of AI-enabled regulatory oversight.
Keywords: AI, AI Tools, Clinical Operations, Clinical Research, Clinical Trial Regulations, Clinical Trials, CRO, Drug Development, FDA, FDA Inspection, Quality, Regulatory, Regulatory Compliance,  FDA Regulations