Join Wilson Sonsini's Eva Yin on November 10, 2026, as she and fellow panelists participate in a live, one-hour briefing on how AI is changing FDA inspections, from how the agency picks its targets to what investigators look for once they are on site. This session is co-sponsored by HSBC Innovation Banking, Wilson Sonsini Goodrich & Rosati, and Healthcare Innovation Catalysts.

AI has arrived on both sides of the inspection. FDA uses its Elsa system to help identify inspection targets, even with a smaller field force, and this spring it issued a warning letter over a company's use of AI in CGMP documentation. This session covers what moves a site up the list, what an inspection looks like, and what companies using AI should have in place before an investigator asks.

Moderated by Joe Biehl, Chief Executive Officer, Healthcare Innovation Catalysts, the speakers will cover:

• Anne Johnson: How AI-informed targeting and a smaller field force are changing inspection planning, and what puts a site on the list
• Ileana Barreto-Pettit, RN, MPH: What happens once investigators arrive, why the same citations top the list year after year, and how AI in the record shows up during an inspection
• Sheila Gwizdak, M.S.: Building AI-enabled quality systems that hold up, and overseeing contract manufacturers doing the same
• Eva F. Yin, Ph.D, MPH, J.D.: Legal exposure around AI in regulated records, and what is reasonable for a pre-FDA company or one working through a CMO

Click here to register for the webinar.