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
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
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
In this QualityHub Brief, pharma companies are introduced to the unique regulatory and manufacturing challenges associated with developing combination products, even when using standard delivery
QualityHub has appointed medical device quality executive Christina Arnt as Vice President of Medical Device Compliance. Arnt brings extensive global quality systems leadership experience from
The US FDA described in a Town Hall webinar how medical device inspections under the Quality Management System Regulation (QMSR) emphasize a flexible, risk-based approach