Back to School AAMI to Hold Nearly 20 Courses, Webinars This Fall

ARLINGTON, Va., Sept. 13 -- The Association for the Advancement of Medical Instrumentation issued the following news release:

The Association for the Advancement of Medical Instrumentation (AAMI) will hold nearly 20 courses and webinars this fall on subjects such as risk management, quality system requirements, human factors, and purchasing controls.

Among the courses is the popular software validation course, which Aaron Leimback registered for. Leimback has plenty of experience in software validation, but not when it comes to medical devices.

"I would like to learn about the similarities and differences between the two fields," says Leimback, software quality assurance analyst at Stryker Instruments in Kalamazoo, MI.

The software validation course explains how to implement effective validation programs, and includes information on the new technical information report (TIR) ANSI/AAMI/IEC TIR800002-1, which provides guidance on the application of the cyber security standard ANSI/AAMI/ISO 14971.

Ling Zou--who works for Bard Access Systems in Salt Lake City, UT--signed up for the course to learn how to comply with U.S. Food and Drug Administration (FDA) requirements. She wants to know how to deal with vendor software. "How do we validate it?" asks Zou, a quality engineering manager. "In order to validate the vendor software, we need to be an expert. If we do not have expertise, how do we handle it?"

Leimback hopes to get some additional tools that will allow him to teach and explain software validation to his coworkers. "Many people view it as a burden and just another way of satisfying regulatory agencies," he says. But he sees much more at stake here. "Validation can help a company potentially save millions of dollars with product recalls and fixing software bugs."

Gear Up for Fall Courses

A full list of the courses and webinars, part of AAMI's Quality System Training Programs, is below. For more information on these courses, visit www.aami.org/meetings.

Table Omitted (http://www.aami.org/news/2010/091310.press.courses.html)

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