FDA

The U.S. Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) has a unique relationship with Kaplan EduNeering: a technology Cooperative Research and Development Agreement (CRADA), in which Kaplan Eduneering provides the on-line training, documentation, and CFR 21 Part 11 validated technology system for "ORA U," FDA's virtual university. Our clients rely on the same CFR 21 Part 11 system used by the same FDA.

For more details, visit our Whitepaper Page and scroll down to download the "How Industry Benefits from FDA's Online Training Program" whitepaper.

FDA uses ORA U to train and certify more than 30,000 federal, state and local investigators in the areas of quality and compliance. To date, more than 100,000 learning activities in areas such as GMP, GCP, and GLP have been created. The CRADA solution, available to Kaplan EduNeering's pharmaceutical, biologics, and medical device clients, provides industry with the same level of preparedness and learning on which FDA relies. The CRADA was renewed through 2011 and expanded to include new technologies.

21 CFR Part 11 Learning Platform | FDA-Authored GMP, GCP, Enforcement Courses

Take a Virtual Tour of FDA:
Kaplan EduNeering has created FDA's virtual tour. This course, available to the public, demonstrates our approach to visual design, interactivity, and integrated testing features.

For FDA ORA Users: visit the FDA ORA ComplianceWire login page to take courses.

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