This course explored basic quality assurance techniques, standards, and risk management principles from product development through the marketing of a new medical product. Course materials covered incorporating quality and quality systems in the discovery and development of new medical products which includes: development, testing for safety and efficacy through clinical trials, manufacturing, approval for market, and post-market activities. Emphasis was on building quality into each step of the process, documentation, quality standards, systems, actions, and techniques.
- Differentiate and identify the salient concepts underlying modern quality management systems throughout the lifecycle of a medical.
- Analyze the Federal Food and Drug Administration (FDA) regulatory environment as it relates to the development, manufacturing, and approval of regulated medical products.
- Apply Good Quality Practices (GxP) including Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and ICH Quality Guidelines within the FDA regulated industry to human subject research in the development of new medical products.
- Analyze relevant requirements for complete and accurate documentation to ensure compliance with current and applicable regulations and guidance documents affecting development of medical product, manufacturing, human subject research, and post- market surveillance.
- Apply quality system approaches to the development of new medical products and conduct of clinical trials to prove safety and efficacy of the new product.
- Apply the principles of risk management in the clinical research environment by incorporating quality and safety principles and practices throughout the product life cycle.