An elective course in the Certificate Program in Medical Product Development.
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 key principles, challenges and issues involved in good manufacturing practices (GMPs) of medical products. 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.
Recommended Prerequisite: MGMT X442.6, Medical Product Quality Systems, or equivalent experience. PLEASE NOTE: Course can be taken concurrently with MGMT X442.6.
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.
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
|Event||Date||Day||Start Time||End Time||Location||Room
|START||06/21/2021||Monday||---||---||Online (Access Begins)||---
|END||08/29/2021||Sunday||---||---||Online (Access Ends)||---