A required course in the Regulatory Affairs and Compliance Certificate Program within the 'Device Track'.
Course closed to new registrations:
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Learn how to continuously evaluate and perform periodic reporting on the safety, effectiveness, and reliability of a medical device for its intended use. Utilizing design controls practices and procedures, participants learn "design transfer" from research and development to manufacturing. Increase your knowledge on managing regulatory affairs activities for engineering design modifications, post approval studies, and after market product changes. Participants learn how to recognize the regulatory pathway for changes in labeling, manufacturing process, design, sterilization, packaging, material and vendor; changes due to customer complaints, product recall or field corrective action.
Prerequisite: BME X412, Regulatory Affairs Planning and Management: Concept Review and Evaluation, or equivalent experience.
Dr. Darin S. Oppenheimer is Executive Director of the Drug Device Center of Excellence, focusing on Medical Devices and Combination Products at Merck, based in Upper Gwynedd, PA.
Darin joined Merck with 16 years of experience in many facets of the Product Development Lifecycle, including regulatory submissions and due diligence. He has actively participated with industry trade organizations and served on standards committees. His time as a research and development scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery.
Darin’s educational background includes an undergraduate degree in Molecular Biology from the University of Tampa, two master’s degrees from Johns Hopkins University in Biotechnology and Regulatory Science, and a Certificate in Biotechnology Enterprise also from JHU. Darin completed his Doctorate in Regulatory Science from the University of Southern California in 2016. Darin is also a 2017 Regulatory Affairs Professional Society Fellow.
Darin has contributed to more than two dozen journal articles in the areas of medical devices, drug discovery, and regulatory affairs. He’s lectured at more than three dozen symposia, and participated in panel discussions and poster presentations at industry conferences. Darin serves on the Editorial Board of the Regulatory Affairs Professional Society, as well as the Editorial Board of the Institute of Validation Technology.
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||04/03/2023||Monday||---||---||Online (Access Begins)||---
|END||05/21/2023||Sunday||---||---||Online (Access Ends)||---