As biotech and In Vitro Diagnostics (IVD) companies mature, the need for professionals with a broad understanding of the skills required to be effective in a biological product development environment will increase. The course focuses on issues moving an IVD product from concept to regulatory approval and market launch. Topics include planning for success by setting product requirements & specifications to meet customer needs, critical path management, resource planning, principles of assay development, instrumentation, role and composition of the product development team, risk analysis, and IVD clinical and regulatory issues including compliance and complaint handling. Specific product development cases will be discussed
Note: 3-6 course hours required online in addition to in-class meetings. Valid email required.
Course Number: BIOL-40244 Credit: 2 units
This course is part of the following Certificate Program(s):
Official web page of the University of California, San Diego.
Advanced Search
Email
Print
Share
Delicious
Digg
Facebook
LinkedIn
MySpace