(ASQ: Milwaukee, Winsconsin) -- As Food and Drug Administration regulations and quality system requirements tighten, manufacturers can’t afford the ramifications of unidentified risks in production. To help educate producers, the American Society for Quality is offering a one-day virtual course on risk management. Participants of the Risk Management for Medical Device program will learn how to evaluate the hazards for possible levels of risk and ways to creatively brainstorm on how to reduce the risk.

The program is a live, instructor-led, interactive Web-based course. It will be held Oct. 3, 2007, from 8 a.m.–4 p.m. CDT. Instructor Barry Craner will outline the common risk-identification and risk-reducing methods applicable to medical device production and to many other industries. Craner is chair of ASQ’s biomedical division and is director of quality assurance for Lipid Sciences Inc.

The course is geared toward quality managers, quality engineers, and quality technicians involved in the development and manufacture of medical devices. Professionals directly involved in meeting the FDA’s quality system requirements such as those in regulatory affairs, quality assurance, process development or manufacturing should also attend.

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