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Medical Device Manufacturing

An elective course in the Certificate Program Medical Device Development.

Course Description

Learn about the essential manufacturing principles for medical device and pharmaceutical products and the regulations governing the medical product manufacturing process. Gain valuable knowledge in understanding the fundamental principles, challenges, and issues involved in medical products' good manufacturing practices (GMPs). Topics include: product development cycle, understanding the customer and their needs, material and process selection, packaging and sterilization, reliability testing, design validation, manufacturing process validation, and developing a manufacturing strategy.

You may access your online course by 12pm (noon) Pacific Standard Time on the start date through your UCI DCE web account at https://ce.uci.edu/. Select “My Account,” then “My Courses” from the menu on the left, and lastly “Access Canvas” to access your online course. Instruction begins promptly on the start date. If you enrolled on or after the start date, you may access your online course two hours from the time of your enrollment. If you have any problems, please contact UCI DCE Student Services at 949-824-5414 or dce-services@uci.edu.

  • Details
  • $735
  • June 20, 2022 to August 28, 2022
  • Delivery Mode: Online
  • Reg#: 00126
  • ID/Units: EECS X445.22  (3.00)
    ( Section 1 )
  • Quarter: SUMMER 2022

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
START06/20/2022Monday------Online (Access Begins)---
END08/28/2022Sunday------Online (Access Ends)---