QHub Insights║Choosing the Right ‘Front Room’ Host for an FDA Inspection
August 25, 2026
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
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
Jennifer Maandi’s lifelong interest in language has shaped a career in medical device quality, where communication, interpretation, and attention to detail are essential. Now joining
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 QualityHub Expert White Paper examines the regulatory foundations, operational principles, and implementation practices associated with effective CAPA systems within the medical device industry. Particular
Despite FDA staffing changes, the agency’s medical device review performance remains strong, according to former FDA leader and current QHub Corporate VP Sean Boyd, who
As the FDA’s QMSR places greater emphasis on risk-based decision-making, medical device manufacturers are expected to align CAPA investigations with the potential impact on product
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
The FDA’s Karen Cruz-Arenas says weak or nonexistent internal audit activities are a recurring QMSR-related inspection observation, with some MedTech companies incorrectly assuming that an