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
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