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.
Sarah D. LaCour, MBS, is a Senior Site Management Associate for Allergan. She also received her B.A. in Biology from Xavier University in Louisiana in 2007. After receiving her B.A. she went on to complete the Clinical Trials: Medical Device and Drug Development certificate program from UCI Division of CE, which led her to Keck Graduate Institute where she completed her Master of Bioscience – Clinical/Regulatory Affairs. Her industry experience has granted her a wide array of viewpoints while working at site, CRO and sponsor levels that have all providing her a strong foundation in clinical research.
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||04/05/2021||Monday||---||---||Online (Access Begins)||---
|END||05/09/2021||Sunday||---||---||Online (Access Ends)||---