Quality Assurance and Control

In Vitro Diagnostics Product Development

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. In this course, learn the requirements for 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):

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Upcoming Sections

Section ID Fee Status
05/09/14 - 05/10/14   (Click to show details) In-class 101034 $550.00 Add to Cart