A CAPA is only as defensible as the evidence behind it. QualityHub SVP Rebecca Fuller explains why Verification of Effectiveness planning should begin with the
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
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
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
This QualityHub Expert Brief examines how clear, SOPs strengthen quality systems by standardizing processes, supporting employee competence, and providing objective evidence that work is performed
This QualityHub Expert Brief examines the evolution of training requirements for makers of medical devices, highlights key differences between FDA’s former Quality System Regulation (QSR)
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