April 19, 2021
Northbrook, Ill. – April 19, 2021 – UL, the global safety science leader, today announced that it has received from the US Food & Drug Administration (FDA) a Leveraging and Collaboration Award for the company’s efforts to modernize and consolidate a life science learning service used by more than 40,000 federal, state and local FDA investigators. The award, from the FDA Office of Regulatory Affairs, recognizes work that demonstrates the agency’s ability to collaborate with other FDA partners.
UL, in partnership with the FDA, created a library of 200 life science eLearning courses. Part of a Cooperative Research and Development Agreement with the FDA to help develop and deliver critical regulatory and compliance training to FDA investigators, the eLearning courses are used by medical device, pharmaceutical, biotech and governmental bodies worldwide. The FDA also utilizes UL’s ComplianceWire® Learning Management System (LMS) to assign and track the training for these courses. ComplianceWire® software automates the creation, delivery, and reporting of role-based training, qualification and compliance.
In 2017, UL and the FDA embarked on a project to modernize and consolidate the agency’s 13 ComplianceWire® learning management systems into a single site. A single repository for training and reporting would improve long-term efficiencies, effectiveness and streamline training management for the FDA and state, local, tribal and territorial inspection staff.
“Over the last three years, UL worked with FDA ORA staff to consolidate key data to allow for ease of use and access to all of our users,” said Patricia Alcock, director, Office of Training Education and Development at the FDA Office of Regulatory Affairs (ORA). “The completion of this project means that FDA ORA staff and our state, local, tribal and territorial partners can easily and quickly get the necessary training and access to knowledge that will ultimately help advance safety and security in the critical work that they do. Our partnership with UL for the project was exceptional. It is for these reasons, we are extremely honored to present to UL the FDA Leveraging and Collaboration Award,” said Alcock.
“The continuum of regulatory pressures facing life sciences companies today are significant. Implementing an ineffective, inefficient or inadequate learning program can jeopardize product safety, weaken brand reputation and negatively impact financial performance,” said Jim O’Keefe, director of Product Lifecycle for ComplianceWire® at UL. “We are honored to receive the FDA Leveraging and Collaboration Award and proud to work with such a collaborative team at the FDA’s Office of Training and Education,” said O’Keefe.
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