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Medical Device Quality Systems

A required course in the Certificate Program in Medical Product Development.

Course Description

Learn about the essential elements of Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's), how there is a commonality between them, and how to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 13485:2016. A detailed analysis of these systems and practical 'how to' recommendations and approaches are presented, with particular emphasis on the United States Food and Drug Administration (FDA) QSR's and GMP's.

Recommended prerequisite: Engrece X445.2, Regulatory Requirements for the Medical Product Industry or equivalent experience.

  • Details
  • $735
  • June 21, 2021 to August 29, 2021
  • Delivery Mode: Online
  • Reg#: 00175
  • ID/Units: MGMT X442.6  (3.00)
    ( Section 1 )
  • Quarter: SUMMER 2021

Instructor


Dr. Albert Rego, Ph.D., M.B.A., is a scientific consultant to the regulated industries, with over thirty years of experience in the pharmaceutical and medical device industries. Areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological, and sterilization technologies. He has experience in performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, regulatory submissions, chemical hygiene plans, analytical chemistry methodologies, and sterilization validation.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

No textbooks are required for this course.

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START06/21/2021Monday------Online (Access Begins)---
END08/29/2021Sunday------Online (Access Ends)---