PRINCETON, N.J.--(BUSINESS WIRE)--UL 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, extending the agreement to 2019. FDA’s CRADA with UL is the only learning technology agreement of its kind between FDA and a private-sector company. This new agreement will expand the learning resources of the Office of Regulatory Affairs’ virtual university (ORA-U). UL EduNeering and FDA originally collaborated and co-developed the ORA-U infrastructure in 1999 to train the agency’s food, drug and medical device investigators.
Global production of FDA-regulated products has quadrupled over the last decade and continues to grow. Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. 40 percent of finished drugs come from overseas, and 80 percent of active ingredients manufacturers are located outside the US. Further, half of all medical devices are imported.
“To meet this global challenge, the FDA is committed to providing high-quality educational opportunities to its investigators, scientists, analysts and state and local regulatory officials,” said Melinda K. Plaisier, FDA’s associate commissioner for regulatory affairs. “The delivery of timely and cost effective web-based distance learning supports FDA’s mission and strategic goals by aiding in the training of FDA personnel and our stakeholders who are geographically dispersed.”
The expanded CRADA between FDA and UL EduNeering is designed to address many of these training needs through services that include:
- Content development services for new curricula on topics related to international inspections and the import/export of products that fall under FDA purview and intra-agency and intra-government cooperative agreements;
- Access to the FDA’s Office of Regulatory Affairs online curriculum via ComplianceWire®, UL EduNeering’s cloud-based learning platform;
- New materials as outlined above, extended to other cooperative international agencies in countries of interest;
- Access to the FDA’s Office of Regulatory Affairs online curriculum and ComplianceWire to designated international counterpart agencies;
- Access to the FDA’s Office of Regulatory Affairs online curriculum and ComplianceWire extended to other US government regulatory agencies;
- Educational content available in a mobile-ready format.
“The globalization of clinical, manufacturing and distribution sites introduces constantly changing risks and challenges in assuring safe, effective and consistent products. Our extended CRADA with the FDA demonstrates the agency’s historic determination to respond to the emerging challenges of a global economy,” said Lynne Budnovitch, Managing Director of UL EduNeering. “We are delighted to play such an important role in meeting the safety and compliance goals of FDA and the regulated community, both domestically and internationally.”
The platform for FDA’s Office of Regulatory Affairs online university is based on UL EduNeering’s ComplianceWire, a fully validated learning management system designed to meet the FDA-regulated community’s high-security needs, including compliance with 21 CFR Part 11. ComplianceWire is available to regulated industry as part of the CRADA and has been deployed to over 250 life sciences organizations worldwide. The platform is available in 34 languages and the CRADA extension will enable expansion of this resource to learners in countries including China, India, Japan, and members of the European Union. The technology provides access to over 500 courses, exams and documents used by investigators, including 145 courses that have been authored or reviewed by FDA and co-developed with EduNeering. These specialized courses provide instruction on subjects including Good Manufacturing Practices, Quality Systems Requirements, Bioresearch Monitoring, and Food Safety. Since the formation of UL EduNeering’s relationship with FDA in 1999, more than 36,000 federal, state and local investigators have been trained using this modality.
About UL EduNeering
UL EduNeering is a business line within UL’s Life & Health business unit. We develop technology-driven solutions that help organizations mitigate risks, improve business performance and establish qualification and training programs through our proprietary, cloud-based platform, ComplianceWire®.
For more than 30 years, UL EduNeering has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. For more information visit www.ULeduneering.com
About UL
UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL uses research and standards to continually advance and meet ever-evolving safety needs. We partner with businesses, manufacturers, trade associations and international regulatory authorities to bring solutions to a more complex global supply chain. For more information about our certification, testing, inspection, advisory and education services, visit www.UL.com.
