UCSC Extension in Silicon Valley, Nov. 2 – Dec. 14, 2009
Cource: Design Control for Product Development
Instructor: Tom Shoup, Ph.D.
Dates and Times: Nov. 2 – Dec. 14, 2009, 6:30 – 9:30 pm
Tuition: $525
See www.ucsc-extension.edu/biosciences for course descriptions and links to all of our bioscience certificate programs. Questions? E-mail biosciences@ucsc-extension.edu or call 408-861-3860.
Course Description:
The successful development of products, especially medical devices, requires that the design be controlled to assure product safety and that the device can fulfill its intended use. This course provides practical understanding of the engineering value of design control as it pertains to product quality. Lectures, interactive discussions and real world examples help students use the nine elements of design control to make design objectives clearer, products more testable, and better satisfy customer requirements—thereby shortening the path to product and business success. This course benefits new and experienced professionals in quality, engineering, regulatory, manufacturing, clinical, and project management functions.
Topics Include:
Design control, the quality system and ISO 13485: A brief introduction
Design and development planning
Design input
Design output
Design review and peer review
Design change controlDesign transfer to manufacturing
Design verification
Design validation and use of statistics
Design history file (DHF)
Instructor Background
Tom Shoup, Ph.D., has more than 20 years of experience in medical device development for class II and class III devices. Past employers include Hewlett-Packard and Siemens, where he held senior management positions with responsibility for product development, project management, and day-to-day compliance with design control and other quality-system regulations.
