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Understanding The Medical Product Development Process: Continuing Professional Development For Life Science Professionals

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Conference

2007 Annual Conference & Exposition

Location

Honolulu, Hawaii

Publication Date

June 24, 2007

Start Date

June 24, 2007

End Date

June 27, 2007

ISSN

2153-5965

Conference Session

Successful Professional Development Programs

Tagged Division

Continuing Professional Development

Page Count

7

Page Numbers

12.1515.1 - 12.1515.7

DOI

10.18260/1-2--1848

Permanent URL

https://jee.org/1848

Download Count

187

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Paper Authors

biography

Rogelio Rodriguez UC Irvine

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Rogelio C. Rodriguez, M.S.
Director, Engineering and Science Programs
University of California Irvine Extension

Continuing Education professional with 12 years experience in the planning, development and implementation of advanced professional development education. Has led continuing education development efforts in the areas of engineering, science, and life sciences. ASEE member, 2006–2009 commissioner for University Continuing Education Association (UCEA) Leadership and Management Commission, and 2006-2007 President for Association of Analytical Chemist (AOAC) Southern California Section.

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Abstract
NOTE: The first page of text has been automatically extracted and included below in lieu of an abstract

Understanding the Medical Product Development Process: Continuing Professional Development for Life Science Professionals

Abstract

Navigating the medical product development maze from concept to market can result in a challenging experience. The life science industry is a highly regulated industry and depending on the medical product and classification (device, pharmaceutical, or biologic) the approval process can be complex and lengthy. Unlike high-tech products such as consumer electronics which may have a relatively short time-to-market cycle, medical products can take anywhere from 3 to 7 years before they make it to the market.

Modern technology has made many inroads in the advancement of medical technology and engineers and scientists are playing a key role. As students make the transition to becoming professionals and professionals seek to enhance their careers, continued education and skills enhancement is taking center stage. This paper describes the development of a continuing education certificate program in medical product development for both professional development and workforce development. Various disciplines may be involved throughout the development cycle from marketing to engineering to regulatory affairs. Possessing a thorough understanding of medical product design and manufacturing increases the level of expertise needed to enhance the safety and quality of medical products. A common development cycle for medical products is presented with explanations of the various phases within the product development cycle.

The Medical Product Development Certificate program has been designed to provide core knowledge of the medical product development process. Through evaluated learning and competency-based courses, students increase their knowledge of clinical and regulatory compliance, good manufacturing practices, and quality assurance.

Rodriguez, R. (2007, June), Understanding The Medical Product Development Process: Continuing Professional Development For Life Science Professionals Paper presented at 2007 Annual Conference & Exposition, Honolulu, Hawaii. 10.18260/1-2--1848

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