Nonconforming Product

The Quality System Regulation requires manufacturers of medical devices to have methods in place for controlling nonconforming product in accordance with the Quality System Regulation 21 CFR 820.90. The disposition and investigation of nonconforming product are essential in ensuring that medical devices are safe and effective. Are all nonconformances corrective and preventive actions (CAPA)? What is the link between nonconformances, nonconforming product and CAPA? What do I do with the product? Can I rework them? This CDRH Learn module and Industry Basics session will answer these questions and others for you and help in the understanding of your FDA regulatory requirements.