Every medical device manufacturer must establish and follow a quality system to help ensure that its products consistently meet applicable requirements and specifications. The quality systems for US Food and Drug Administration (FDA)-regulated products (food, drugs, biologics and devices) are known as current good manufacturing practices (CGMPs). CGMP requirements for devices are outlined in 21 CFR, Part 820.
This course reviews the background and history of the Quality System Regulation (QSR) set forth by FDA, the essential elements of a quality system, and the applicability and exemption of the QSR.
This course is intended to facilitate an understanding of the intent and expectations of the quality systems regulations, as prescribed by FDA in the quality arena, how to implement a quality system, and how the QSR can be applied to a medical device manufacturer.
Learning Objectives
Upon completion of this course, participants should be able to:
- Discuss the QSR in terms of application and requirements of a medical device company for designing, manufacturing, packaging and distributing medical devices.
- Cite the requirements for a quality management system that a medical device manufacturer must establish and implement.
- Apply the requirements mandated by FDA for medical device manufacturers to the different processes within the organization.
- Explain the basics of implementing a quality system and interpreting the QSR for practical application for the organization.
- Identify the different procedures, work processes and quality records that must be generated to support an inspection by FDA.
Target Audience
This course is designed for quality assurance (QA), regulatory, manufacturing and marketing personnel; individuals who are new to medical device companies; and executive management.