Presenter: Aarti Kamath is a quality professional with more than a decade of experience in the medical device and pharmaceutical industries, specializing in supply chain quality and operational excellence. She holds a Master of Science degree in Biomedical Engineering from Drexel University. Aarti is ASQ-certified as a Certified Quality Engineer (CQE) and a Certified Manager of Quality/Organizational Excellence (CMQ/OE).
About this topic: As pharmaceutical and medical device companies increasingly rely on contract manufacturers, traditional audit-focused supplier quality models are no longer sufficient to ensure sustained compliance and performance. Organizations must shift toward integrated, risk-based oversight that drives proactive control and clear accountability. This presentation introduces a practical framework for building a scalable contract manufacturing oversight program, including risk-tiering, defined governance models, performance metrics, and structured change management.