“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
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
Implementing a risk-based CAPA approach requires more than adopting a new decision tree, as demonstrated by QualityHub Senior Consultant Aryssa Wernle’s experience implementing MDIC’s “Make
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
As makers of medical devices expand their use of AI to generate SOPs and other controlled documents, the focus is shifting from content creation to
A strong Culture of Quality in medical device companies is demonstrated through leadership actions and employees’ willingness to raise concerns, among other factors, rather than