Do you speak the language of IVD? Of course you do, or you wouldn't be visiting this blog. But maybe you could use a refresher course. Or perhaps you're a little fuzzy on the declensions of the IVD product development process. If so, you might be interested in a course offered by UC San Diego Extension on In Vitro Diagnostics Product Development, scheduled for November 2 and 3, 2012. "The first two-day course was a great success, so we will be offering it again, with updates of course," says instructor Glen Freiberg, MA, RAC, Regulatory and Clinical Affairs, B-M, Bard, FDA, Gen-Probe.
The course will focus on issues related to moving an IVD product from concept to regulatory approval and market launch. Specific topics include drafting a package insert, design control, risk analysis and FMEA, principles of assay development, and a pair of case studies on blood screening and cancer diagnostics. Since this is a course, there will be an exam (so pay attention).
In addition to Freiberg, instructors include Larry Mimms, PhD, who has more than 20 years of experience in product development, strategic planning, and business development with the likes of Abbott Labs and Gen-Probe; Valerie Day, MS, MBA (Abbott Labs, Gen-Probe, Dexcom, Quidel); and Damon Getman, PhD, R&D and Product Development at Gen-Probe.
The two-day course costs $445. To register and for additional information, go to the UC San Diego Extension website.