- Medical Device
- Health Care
- Engineering & Construction
- Manufacturing and General Industry
- Regulatory Compliance
- Enterprise Learning Management
- Learning Content
- Safety and Corporate Culture
- Ethics and Corporate Responsibility
- EduXpress - SMB Online Compliance Solution
- E-Commerce Online Courses
- Purchase Courses
- Resource Center
- About Us
- Contact Us
FDA Virtual University
In 1999, the US Food and Drug Administration (FDA) entered into its first and only technology Cooperative Research and Development Agreement (CRADA) between its Office of Regulatory Affairs (ORA) and UL for the development of an online university to meet the knowledge and certification needs of more than 30,000 inspectors and investigators.
UL designed, deployed and continues to operate "ORA-U," one of the most technologically advanced virtual universities in operation. ORA-U is built on UL's signature technology platform ComplianceWire®, providing FDA managers with real-time data to monitor and document all learning activities. A constantly expanding curriculum includes more than 110 individual subjects related to FDA enforcement policies and activities, including GMP, GCP, QSIT and QSR.
Following the rollout of ORA-U, FDA saw a dramatic decline in the time required to bring new inspectors and investigators to proficiency. The 600 inspectors hired by FDA following implementation of ORA-U reached proficiency in only three months, compared to the previous 6 to 12 month standard. Equally important to FDA, inspectors and investigators received standardized content that assured a common knowledge level among enforcement personnel, regardless of location.
FDA renewed its CRADA with UL in 2002 and again in 2006, expanding its scope with the addition of new technologies that would embed into the existing ORA-U infrastructure for expanded testing and document management capabilities. A virtual audit will be developed to assist both FDA investigators and the regulated industry to assess and remediate risk areas in advance of an audit.
- White Papers
- Case Studies