FDA-Authored QSR Curriculum

Download this datasheet to learn more about Kaplan EduNeering's QSR curriculum, which reflects the FDA's most current requirements, priorities, and policies in the areas of quality systems, import operations, medical device regulations, drug safety and more. 

As noted on the FDA Quality System Regulation guide, Section 820.5 of the QS regulation requires that "each manufacturer shall establish and maintain a quality system that is appropriate for the specific device(s) designed or manufactured, and that meets the requirements of this part." If manufacturers do not implement certain GMP requirements which are qualified by the term "where appropriate," they should document their justification for nonimplementation.

The QSR curriculum includes 11 FDA-authored courses that specify general objectives such as use of trained employees, design reviews, design validation, calibrated equipment, process controls, etc., rather than methods, because a specific method would not be appropriate to all operations.

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