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 till 2019. US FDA’s CRADA with UL is the only learning technology agreement of its kind between US FDA and a private sector company.
This will help UL EduNeering to increase its presence in India to serve compliance and regulatory needs of the fast growing life science community.
The extended CRADA agreement between US FDA and UL EduNeering is designed to address many of the training needs through services in India that include content development services for new curricula on topics related to international inspections and the import and export of products that fall under US FDA purview and intra agency and intra government cooperative agreements; access to the FDA’s Office of Regulatory Affairs online curriculum via ComplianceWire, which is UL EduNeering’s cloud based learning platform.
The agreement will ensure focus on global inspections, multi- linguality, import and export regulations, training and mobile technology. Says Lynne Budnovitch, managing director, UL EduNeering, “We are delighted to play such an important role in meeting the safety and compliance goals of US FDA and the regulated community, both domestically and internationally.”
This new agreement will expand the learning resources of the Office of Regulatory Affairs’ virtual university, UL EduNeering and US FDA which 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 US FDA regulated products has quadrupled over the last decade and continues to grow. Today, US 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 US FDA is committed to providing high quality educational opportunities to its investigators, scientists, analysts, state and local regulatory officials,” says Melinda K Plaisier, US FDA’s associate commissioner for regulatory affairs.
She explains, “The delivery of timely and cost effective web based distance learning supports US FDA’s mission and strategic goals by aiding in the training of US FDA personnel and our stakeholders who are geographically dispersed.”
UL offers innovative technologies that prepare companies not only to have standardized processes, but also an audit readiness by adhering to GMP requirements. The organization already works with India’s Central Drugs Standard Control Organization (CDSCO) to train inspectors on the ISO 13485 quality management system. "We at UL understand the challenges pharmaceutical manufacturers face in navigating through the complex regulatory requirements to ensure their drugs are safe and meet market demands,” says Suresh Sugavanam, MD, UL India and South Asia.
UL EduNeering, part of the Life and Health Division of UL, is expanding its services to the Pharmaceutical, Medical Device and Biologics industries in India.