What quality teams need to be ready for in 2027:

For twenty-five years you knew what an FDA inspection looked like. In 2026 that changed: QSIT is gone, the inspection model is new, records that were off-limits for decades are now fair game, and FDA is operating differently. At the same time, tests that didn’t exist a year ago showed up, like a customer's procurement team asking how your AI is governed. That all carries into 2027, and it shapes the audits, reviews, and diligence you'll face next year. "We passed our last audit" no longer means "we're covered." This summit is a day spent on what changed, where it's heading, and how to know if you’re ready.

Why this, why now
You're planning 2027 right now. The scrutiny your quality system will face next year was largely set by four changes that already landed in 2026, and most teams haven't fully absorbed them:

• The FDA inspection model is new. On February 2, 2026, the FDA retired QSIT, the checklist method it used for a quarter century, and replaced it with a risk-based program (CP 7382.850). Inspectors now follow your risk documentation as the roadmap, and internal audits, supplier audits, and management reviews are no longer off-limits. Your 2027 inspections run on this model, not the old one.

• The FDA itself is operating differently after significant staffing reductions, which has changed how and when scrutiny shows up, and there's no sign that reverses next year. The agency has built out internal AI tools and is piloting single-day inspections using AI to identify low-risk facilities. Cuts combined with modernization may add new twists to the inspection schedule.

• The question of AI governance can’t be avoided. Customers, notified bodies, and procurement teams are asking how teams govern their AI. Expect that in more contracts and qualifications in 2027, not fewer.

• Scale and diligence bring their own reviews. QMSR transitions, an acquirer's diligence, a major customer's vendor qualification: each tests your quality system on someone else's clock, and that pressure grows as you grow.