MD&M Midwest

MD&M MidWest

October 28 - 29, 2026
Minneapolis Convention Center
Minneapolis, MN

Medicept Founder F. David Rothkopf will speak during the event:

This Is Not Your Father's FDA Inspection

Thursday, October 29 - Room 101

In February 2026, FDA implemented the Quality Management System Regulation (QMSR), retired the longstanding QSIT inspection model, and introduced a new inspection technique under Compliance Program Manual CP 7382.850. Unlike ISO 13485 certification or MDSAP audits, this risk-driven approach evaluates six QMS Areas and four OAFRs, with a sharp focus on data analysis, trending, continuous improvement, management oversight, and whether a company’s quality system is actually working. Internal audits, supplier audits, management reviews, and even past records are now open to inspection, making much of what companies learned from previous FDA inspections obsolete.

Drawing on experience from more than 60 FDA inspections—including four domestic and international inspections conducted under the new method as of April 2026—this session will explain how FDA’s approach has changed and how to prepare before your next inspection.

Planning to attend MD&M?

Medicept is offering an exclusive discount for MD&M Midwest registration. Visit mdmmidwest.com and use code SPKRGST26 when registering to receive your discount.