Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and CAPA. It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard. Note: Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.     Read more

Begin your journey into supplier quality management with this foundational course. Discover the regulatory requirements from FDA, EU GMP, and WHO guidelines while exploring the essential concepts of supplier selection, qualification, risk assessment, and performance monitoring. This introductory module establishes the critical framework for understanding how effective supplier relationships directly impact product quality, patient safety, and business success. Build your foundational knowledge of the four-stage supplier lifecycle and learn why robust supplier quality management is both a regulatory imperative and a strategic business advantage. Read more

This module provides a systematic approach to selecting, evaluating, and qualifying suppliers and contractors. It covers the complete supplier lifecycle from initial need identification through ongoing relationship management. The module emphasizes that supplier selection goes far beyond choosing the lowest-cost option, focusing instead on total cost of ownership, long-term partnership success, and comprehensive risk assessment.  Read more

This module emphasizes the critical role of documentation in Supplier Quality Management to ensure compliance, mitigate risks, and maintain supply chain quality. It explores verification methods, supplier file management, and the benefits of scalable, integrated systems. Read more

This module provides essential knowledge and practical guidance on implementing quality risk management (QRM) principles within supplier quality management systems. Explored are the regulatory requirements and practical application of risk-based approaches to managing third-party suppliers, materials, and services. Read more

This module equips quality and procurement professionals with practical strategies for establishing and sustaining effective supplier relationships that foster business success. In today's interconnected supply chain environment, your suppliers are extensions of your organization, making relationship management a critical competency for ensuring product quality, delivery performance, and customer satisfaction. Read more