Quality System Regulation (QSR)
This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR. It is advisable to have a copy of the QSR in hand to follow along as the course progresses. This course reviews:
- the background and history of the Quality Systems Regulation (QSR);
- the essential elements of an acceptable quality system;
- the applicability and/or exemption of QSR paragraphs to certain cases; and
- the minimum regulatory requirements for manufacturing and marketing medical devices in the US.
At a Glance
- Target Audience: This course is designed for quality assurance (QA), quality control (QC) regulatory, manufacturing and marketing personnel as well as individuals who are new to medical device companies and executive management.
- Learning Level: Basic
- Total Length of Course: 5 Hours
- RAC Points: 5
- Medical Device Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Understand and reference the QSR in terms of the requirements for a medical device manufacturer when designing, manufacturing, packaging and distributing medical devices, as well as the applicable post distribution functions.
- Understand the QSR requirements for a Quality Management System (QMS) in order to advise a medical device manufacturer about the establishment, implementation, and maintenance of an effective QMS.
- Apply the requirements mandated by FDA for medical device manufacturers to the different processes within the organization, including those events that occur post distribution to market, such as installation, servicing or customer complaint handling.
- Identify the different procedures, work processes and quality records that must be generated to support FDA compliance to the QSR.
Lesson Titles
- Lesson 1: Quality System Regulations
- Lesson 2: Subpart C–Design Controls
- Lesson 3: Subpart D–Document Controls
- Lesson 4: Subpart E–Purchasing Controls
- Lesson 5: Subpart F–Identification and Traceability
- Lesson 6: Subpart G–Production and Process Controls
- Lesson 7: Subpart H–Acceptance Activities
- Lesson 8: Subpart I–Nonconforming Product
- Lesson 9: Subpart J–Corrective and Preventive Action
- Lesson 10: Subpart K–Labeling and Packaging Control
- Lesson 11: Subpart L–Handling, Storage, Distribution, and Installation
- Lesson 12: Subpart M--Records
- Lesson 13: Subpart N–Servicing
- Lesson 14: Subpart O–Statistical Techniques
This course is also included in:
