QS Regulation 3: Design Controls

<p>Based on regulatory authority and findings that a significant portion of device recalls were attributed to faulty design, FDA included design control requirements in the Quality System (QS) Regulation. This course, the third in a series of Quality System Regulation courses, addresses design controls requirements of the Quality System Regulation. Topics include the design plan, the design review, verification, and validation. After completing this course, you will be able to recognize: the design control requirements of the QS Regulation; terms associated with design controls; and requirements for design control procedures, Learners should complete QS Regulation 1: Overview and General Provisions and QS Regulation 2: Quality System Requirements before taking this course.</p>

After this course learners will be able to recognize the design control requirements of the qs regulation recognize the terms associated with design controls. recognize requirements for design control procedures (including planning, input and output, review, verification, validation, transfer, changes, and the design history file).