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Hundreds of pharmaceutical, biotechnology and biologic facilities worldwide rely on UL to assure regulatory compliance, product safety and workforce productivity in a fast-changing global economy. We support our clients through services tailored to the specialized requirements of clinical trials, manufacturing operations, sales and marketing, and post-marketing activities.
Our combination of educational resources, technologies and services provides a robust and cost-effective solution that enables enterprise-wide knowledge transfer and facilitates compliance with US and global regulatory agencies and organizations, including FDA, EMEA, ICH and ISO.
21 CFR Part 11-Validated Learning Management System
ComplianceWire®, UL’s 21 CFR Part 11-validated learning management system (LMS) and our extensive curricula that target the knowledge needs of the industry are developed and used by the FDA to train, test and certify its investigators. ComplianceWire is a cloud-based solution, providing a proven outsourced model that imposes minimal capital, labor or maintenance cost on our clients while assuring availability and security.
The same technology and curricula used by FDA are available exclusively to UL’s clients. All standard courses, including those that comprise our GCP, GMP, QSR and pharmacovigilance curricula, are authored or reviewed by the FDA in a unique partnership between the agency and UL.
Courses are updated regularly to reflect the most current regulatory requirements. Customized courses, whether based on our courses or developed exclusively for an individual client, support targeted objectives, such as strengthening a global corporate culture; achieving enterprise-wide regulatory compliance; and minimizing risks to patients, employees and company shareholders.
Our technology is routinely integrated with other critical business systems, including human resource information systems, document management and enterprise resource planning, to create a turnkey infrastructure for compliance and business management.
UL’s solution supports initiatives by companies, contract research organizations (CRO), and contract manufacturing organizations (CMO) in areas as diverse as:
- Global and national regulatory compliance;
- New hire orientation and employee development;
- Management of contractors and outsourced business process personnel at CROs/CMOs;
- Assimilation of acquired personnel;
- Part 11 validation and audit-ready documentation;
- Reinforcement of ethical values and behaviors;
- Patient and product safety;
- Risk assessment and mitigation.
Global Regulatory Compliance Learning
Addressing International Regulatory and Corporate Compliance Requirements