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FDA Extends Partnership with Kaplan EduNeering for Five Years

Learning CRADA has supported training needs for more than 30,000 regulators during the ten year partnership.

Princeton, NJ, November 08, 2009 --( Kaplan EduNeering, a leading provider of compliance and knowledge management solutions, and the US Food and Drug Administration (FDA), have extended their Cooperative Research and Development Agreement (CRADA) for five additional years. FDA’s CRADA with Kaplan EduNeering remains the only learning technology agreement of its kind between FDA and a private-sector company. The new extension will expand the learning resources of the Office of Regulatory Affairs’ virtual university, known as ORA U, which Kaplan EduNeering and FDA originally co-developed in 1999, to train the agency’s food, drug and medical device investigators.

“Under the new administration, FDA is increasingly focused on assuring global safety standards across the US and abroad,” said Lisa Clune, President of Kaplan EduNeering. “The work we accomplish through ORA U provides investigators at all stages of their careers access to the advanced education they need to not only support FDA as an enforcement agency, but also as a resource for the regulated community in implementing best practices. We are delighted that our partnership with FDA will not only continue, but expand globally.” Earlier this year, the scope of the CRADA was expanded to support FDA’s outreach to non-US regulatory agencies.

ORA U is based on ComplianceWire®, Kaplan EduNeering’s Software as a Service (SaaS) technology. ComplianceWire is a fully validated learning management system designed to meet the FDA-regulated community’s high-security needs, including compliance with 21 CFR Part 11. The technology provides access to nearly 500 courses, exams and documents used by investigators, including 145 courses that have been authored or reviewed by FDA and co-developed with Kaplan EduNeering. These specialized courses provide instruction on subjects including Good Manufacturing Practices, Quality Systems Requirements and Food Safety. Since the formation of Kaplan EduNeering’s relationship with FDA in 1999, more than 30,000 federal, state and local investigators have been trained through this program.

The same comprehensive learning solution developed for ORA U is available to regulated industry as part of the CRADA. In addition to FDA, ComplianceWire is used by the US Department of Agriculture and more than 100 life sciences companies with employees in more than 50 countries. As the CRADA is internationalized, courses in multiple languages are being introduced to meet the needs of the FDA’s counterparts in countries including China, India, Mexico, Canada and members of the European Union.

About Kaplan EduNeering
Kaplan EduNeering ( is part of Kaplan, Inc., a leading global provider of educational services to individuals, schools and businesses. Kaplan is a subsidiary of The Washington Post Company (NYSE: WPO). Kaplan EduNeering develops technology-enabled knowledge solutions for assuring regulatory compliance and improving business performance. Kaplan EduNeering is headquartered in Princeton, NJ, and has offices in Houston, TX, Bloomsburg, PA, and London, UK.

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Kaplan Eduneering
Ellen Leinfuss

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