Beginner (No knowledge at all of the topic).
This introductory course provides a comprehensive overview of the US FDA Quality System Regulation (QSR) for medical devices. The course also covers the Quality System Inspection Technique (QSIT) approach to auditing, with a focus on management controls, design controls, production and process controls, corrective and preventive action, and other key quality system requirements. Participants will gain a solid understanding of the regulatory requirements and best practices for maintaining a compliant quality system for medical devices, as well as practical guidance for preparing for an FDA audit.
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