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

FDA uses ORA U to train and certify more than 35,000+ 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 UL's pharmaceutical, biologics, and medical device clients, provides industries with the same level of preparedness and learning on which FDA relies. The CRADA was recently renewed through 2014 and expanded to include new technologies.

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

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