Application of Quality System Regulation in Medical Device Design and Manufacturing

RGA 6233 4 Quarter Hours
Course Level CPS - Graduate
Description Introduces the Food and Drug Administration’s (FDA) Quality System Regulations (QSRs) and describes how these regulations can improve the safety and efficacy of medical device products. Discusses the legislative origins of QSRs, their historical evolution, as well as the details of how they are implemented. Examines case studies and empirical examples of QSRs that have been employed by individual medical device manufacturers during the product commercialization process. Offers students an opportunity to develop an understanding of FDA’s expectations for product design control; the structuring of quality system documentation; and principles of practical QSRs within the context of medical device manufacturing, packaging, and distribution. Encourages students to develop strategies for customizing QSRs to particular companies, device products, and manufacturing environments.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

Section 05
CRN 20487
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Carol Morello
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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