<strong>Medical</strong> <strong>Product</strong> <strong>Development</strong><strong>Certificate</strong> <strong>Program</strong><strong>UC</strong> <strong>Irvine</strong> Extension’s <strong>Medical</strong> <strong>Product</strong> <strong>Development</strong><strong>Certificate</strong> <strong>Program</strong> was developed with governmentand industry advisors. It fulfills a recognized need forcomprehensive professional learning in the successfuldesign, development and delivery of medical devices,pharmaceuticals and other biomedical products.This certificate program will benefit life sciencemanagers including research scientists and productmanagers, regulatory affairs and quality assuranceprofessionals, engineers working in biomedicalproduct design and development, manufacturingprofessionals, clinical managers and other healthcareprofessionals.Coursework addresses the breadth of the developmentprocess, including a thorough understanding of compliance,engineering for improved performance, howto mitigate commercial and financial risks and buildmarketing success.The <strong>Medical</strong> <strong>Product</strong> <strong>Development</strong> program is also aRegulatory Affairs Professional Society (RAPS) registeredprovider for professional development, and offersqualifying credits toward recertification as a RegulatoryAffairs Certified (RAC) professional.<strong>Program</strong> Benefits Gain the knowledge needed to design and createmedical devices and pharmaceuticals Acquire an understanding of the medical deviceproduct development process and knowledge neededto manage medical device intellectual property rights Learn how to implement successful medical devicedesign and manufacturing by avoiding commonquality and regulatory pitfalls<strong>Certificate</strong> RequirementsA certificate is awarded upon completion of 15 credit units(9 required and 6 elective credit units), with a grade pointaverage of “B” or better.All requirements must be completed within five (5) yearsafter the student enrolls in his/her first course.Note: Six credit units may be counted toward theClinical Trials: <strong>Medical</strong> Device and Drug<strong>Development</strong> <strong>Certificate</strong> <strong>Program</strong>.Transfer CreditGraduates from <strong>UC</strong> <strong>Irvine</strong> Extension’s <strong>Medical</strong> <strong>Product</strong><strong>Development</strong> program are eligible to transfer credits toUniversity of Nebraska-Lincoln’s Masters in EngineeringManagement.Advisory Committee Matthew Jenusaitis, President and CEO, OCTANe Dan Modi, Director, Quality & Regulatory Certification,Alcon Research, Ltd. Albert Rego, Scientific Consultant to the Life ScienceIndustry Bruce Sargeant, President, Source Scientific LLC Sumit Sen, Chemist (Technology-Based Expert), U.S.Food and Drug Administration Eric Sun, CEO, QS Labs Carl Wyrwa, Director of Quality, Beckman Coulter, Inc. Jeff Yuen, President & CEO, Jeff Yuen & Associates, Inc.OCRA members receive a 10% discount! Earn credits to qualify for RAC recertification. <strong>UC</strong><strong>Irvine</strong> Extension is a RAPS registered provider forprofessional development Learn from instructors seasoned in practical industryexperience who share their knowledge effectivelyFor more information: Jennifer Spitzer (949) 824-9722; jspitzer@uci.edu