A required course in the Certificate Programs Medical Device Development and Regulatory Affairs and Compliance.
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: EECS_X445.2, Regulatory Requirements for the Medical Devices or equivalent experience.
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||06/20/2022||Monday||---||---||Online (Access Begins)||---
|END||08/28/2022||Sunday||---||---||Online (Access Ends)||---