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, 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. UL EduNeering, part of the Life & Health Division of UL is expanding its services to the Pharmaceutical, Medical Device and Biologics industries in India.
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. UL in India is well-positioned to serve the compliance and regulatory needs of the fast-growing life science community. The organization already works with India’s Central Drugs Standard Control Organization (CDSCO) to train inspectors on the ISO 13485 quality management system.
“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.”
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. UL offers innovative technologies that prepare companies not only to have standardized processes, but also an audit readiness by adhering to GMP requirements, so that the best practices percolates to each level in the organization. We look forward to developing many strong relationships that assist pharmaceutical organizations throughout India to meet their goals of quality and compliance.” says Suresh Sugavanam, MD, UL India and South Asia.
The expanded CRADA between FDA and UL EduNeering is designed to address many of these training needs through services in India 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 Compliance Wire, a fully validated learning management system designed to meet the FDA-regulated community’s high-security needs, including compliance with 21 CFR Part 11. Compliance Wire 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, members of the European Union, and others. 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 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.
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