e-Learning Courses Facilitate FDA Compliance

Originally Published MPMN November 2002

E-NEWS

e-Learning Courses Facilitate FDA Compliance

Zachary Turke

In a bid to meet the lifelong learning goals of science professionals, the International Society for Pharmaceutical Engineering (ISPE; Tampa; FL) and EduNeering Inc. (Princeton, NJ) have partnered to offer a series of e-learning courses in the areas of life sciences and FDA compliance. Available 24 hours a day, 7 days a week, the 65 courses cover topics that include good manufacturing practices, validation, Part 11 compliance, advanced quality system regulations, FDA investigation basics, and food and drug laws. The library of courses can be accessed at www.ispe.org/educ/elearnlib.htm.

As another part of its partnership, the two companies will also codevelop an e-learning series on computer system validation for FDA's Ora U virtual university. Conceived under a cooperative research and development agreement between the government agency and EduNeering, this university provides up-to-date training for FDA investigators, inspectors, and regulators. Available in the fourth quarter of 2002, the four-unit computer system validation series is designed to assist these personnel in recognizing the critical aspects of computerized systems during preapproval and routine good manufacturing practices inspections. The ISPE's good automated manufacturing practices guide will serve as the reference book for the course.

As industry professionals will be allowed to access select Ora U courses via ISPE's Web site for the first time, society president Bob Best predicts that both the private and public sectors will benefit. "By providing a mechanism for shared educational resources between industry and government employees, there will be greater consistency, advancement, and excellence in pharmaceutical manufacturing," says Best.

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