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Medical Product Development

Certificate Program Online!

Overview

Emerging technologies, ever-changing regulations, and increased competition create many challenges for the medical product industry. UC Irvine Extension's program, developed with government and industry advisors, fulfills a recognized need for comprehensive professional learning in the successful design, development and delivery of medical devices, pharmaceuticals, and other biomedical products. The curriculum addresses the breadth of the development process, including a thorough understanding of compliance, engineering for improved performance, how to mitigate commercial and financial risks, and building marketing success.

Who Should Enroll

  • Regulatory professionals, such as those in regulatory affairs or quality assurance
  • Engineers, such as those involved in biomedical product design and development
  • Manufacturing professionals
  • Clinical managers and other healthcare professionals
  • Life science managers, such as research scientists and product managers

Program Benefits

  • Gain the knowledge needed to design and create medical devices and pharmaceuticals
  • Acquire an understanding of the medical device product development process and knowledge needed to manage medical device intellectual property rights
  • Learn how to implement successful medical device design and manufacturing by avoiding common quality and regulatory pitfalls
  • UC Irvine Extension is a RAPS registered provider for professional development
  • Earn credits to qualify for RAC recertification
  • Learn from instructors seasoned in practical industry experience who share their knowledge effectively

Certificate Eligibility and Requirements

A certificate is awarded upon completion of 15 credit units (9 required and 6 elective credit units), with a grade point average of "B" or better. Note: Six credit units may be counted toward the Clinical Trials: Medical Device and Drug Development Certificate Program. To become an official candidate in the program, students pursuing the certificate must submit a Declaration of Candidacy. Students are encouraged to declare candidacy as soon as possible, but no later than after the third course in the program. To receive the certificate after completing all program requirements, students must submit a Request for Certificate. All requirements must be completed within five (5) years after the student enrolls in his/her first course. Students not pursuing a certificate are welcome to take as many individual courses as they wish.

Stay Informed About
Medical Product Development

Compliance, Regulatory & Medical Product Development: Education Planning Session
Free Event: Tuesday, August 26, 2014

RSVP

Regulatory Affairs: An Opportunity to Excel in Biotechnology
View Recording

Compliance, Regulatory & Medical Product Development: Education Planning Session
Recorded 3/5/14
View Webinar

Transfer Credits

Graduates from UC Irvine Extension's Medical Product Development program are eligible to transfer credits to University of Nebraska-Lincoln’s Masters in Engineering Management and University of Wisconsin-Platteville Masters of Science in Engineering.

Advisory Committee

  • Matthew Jenusaitis, President and CEO, OCTANe
  • Dan Modi, Director, Quality & Regulatory Certification, Alcon Research, Ltd.
  • Albert Rego, Scientific Consultant to the Life Science Industry
  • Bruce Sargeant, COO, Source Scientific
  • Sumit Sen, Chemist (Technology-Based Expert), U.S. Food and Drug Administration
  • Del Stagg, Ph.D., founder, Orange County Regulatory Affairs (OCRA) and North Carolina Regulatory Affairs Forum (NCRAF)
  • Eric Sun, CEO, QS Labs
  • Carl Wyrwa, Director of Quality, Beckman Coulter, Inc.
  • Jeff Yuen, President and CEO, Jeff Yuen & Associates, Inc.

On-site Training Available

Through Corporate Training, we can deliver this program or customize one that fits your organization's specific needs. Visit Corporate Training or call (949) 824-1847 for information.

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