Blog | R. Chase Consulting

Your Quality Culture? The QMSR Says Plenty—And So Will the FDA

Last week, I shared insights on the FDA's upcoming review of internal audits and management reviews under the new Quality Management System Regulation (QMSR), set to take effect on February 2, 2026. Today, let's connect that to the vital concept of quality culture. The pharmaceutical industry has long emphasized quality culture, with the Center for Drug Evaluation and Research (CDER) introducing the Quality Management Maturity (QMM) program to systematically evaluate and rate

Ricki Chase

Dec 23, 20254 min read

FDA Can See Your Audit Reports and Management Reviews – So What, Who Cares?

Much ado about nothing? Or a wake-up call for medical device manufacturers? As the FDA's new Quality Management System Regulation (QMSR) approaches its effective date of February 2, 2026, one change sparking heated debate is the agency's expanded access to internal audit reports and management reviews. While these have long been fair game under existing regulations, FDA policy historically shielded them from routine inspections. Now, with QMSR harmonizing the Quality System R

Ricki Chase

Dec 18, 20253 min read

History and Why FDA’s Reversion to “Generalist” Investigators May Finally Solve the Combination Product Problem

Having read several articles on LinkedIn and held many spirited conversations with ex-FDA colleagues, I want to offer a different perspective on the move from specialized investigative staff back to a more generalist approach. The History of FDA Investigators Most are familiar with the history. The FDA's Office of Regulatory Affairs (ORA) traditionally operated with investigators starting as generalists, honing their skills in food programs—particularly general sanitation ins

Ricki Chase

Dec 17, 20254 min read