Quality Systems for Regulatory Compliance
Learning Objective:At the end of the course, a student who has mastered the course material should be able to:
- Demonstrate understanding of how the FDA approaches quality systems and controls
- Demonstrate a functional understanding of the components of an integrated quality system for regulatory compliance for biomedical devices
- Demonstrate practical understanding of the main tools within the quality craft (Ex: Control documents, CAPA, quality systems records, benefit-risk assessments, statistical techniques)
- Demonstrate practical understanding of ethics and compliance issues related to medical device development and manufacturing.
Course runs Mod 2 & 3: June 10 - July 30.
Medical devices are developed and manufactured in a highly regulated environment. This course will provide a basic introduction, overview, and systematic study of the intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices. Focus is on understanding the critical elements of quality systems and quality compliance from a risk analysis perspective. Instruction in regulatory science of quality systems and compliance is provided by academics, FDA, and industry representatives with expertise in their fields. This course is part of a three-course series which will be introduced in class. This course will be delivered entirely on-line through learning modules and video conferenced Q&A.
- Intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices
- 21 CFR Part 820 Quality Systems Regulation of the FDA
- Critical elements of regulatory science and use of quality systems for compliance from a design control perspective
- Important roles of a quality systems manager and members of the team
- Benefit / risk analysis and management as a foundation for decision making