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
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
Who you put in the “front room” can make or break an FDA inspection. QualityHub’s Anne Albertz explains why the best host isn’t your top
Mock audits should do more than verify compliance. QualityHub experts say manufacturers should use realistic, risk-based practice inspections that mirror the FDA’s investigative approach, prepare
This QHub Insights article explores why effective communication is one of the most critical, yet often overlooked, elements of FDA inspection readiness. It explains how
In this QHub Insights article, QualityHub experts explain why a well-organized “back room” is essential to a successful FDA inspection, serving as the operational hub
Three QualityHub subject matter experts discuss the US FDA’s updated Compliance Program Manual for MedTech, which gives medical device manufacturers a roadmap of inspection priorities