MedTech manufacturers would be wise to watch how the FDA is using AI, including for inspections, as closely as they manage their own use of
A CAPA is only as defensible as the evidence behind it. QualityHub SVP Rebecca Fuller explains why Verification of Effectiveness planning should begin with the
Manufacturers that can quickly explain how they validated their software can clear that part of an FDA inspection or notified body audit in minutes, Johnson
“Normalization of deviance” happens when a team keeps accepting small departures from requirements because nothing bad has happened yet, and clean audits, healthy metrics and
Having the right records ready is only half of FDA inspection preparation. QHub Principal Consultant Anne Albertz explains how to prepare Subject Matter Experts to
A smooth FDA inspection can still collapse at the closeout meeting, QualityHub’s Dan McMinn warns. Issues thought resolved days earlier can resurface as findings, especially
QualityHub experts say the opening minutes of an FDA inspection can set the tone for everything that follows. Consultants Dan McMinn and Anne Albertz outline
QualityHub welcomes Melinda Novatny as Senior Principal Consultant, bringing nearly a quarter century of regulatory affairs and quality leadership from Philips Healthcare and Integra LifeSciences.
Part 2 of 2: This Insights piece rounds out the inspection response team, focusing on the scribe, the facility escort, and SMEs, and makes the
Part 1 of 2: This Insights piece makes the case that FDA inspection readiness starts with deliberately structuring a small, well-rehearsed “front-room” team – typically