As companies enter new markets, they often ask: "which regulations do we need to concentrate on as we build processes and educate our personnel?"
UL partners with companies to deliver convenient and targeted regulatory education, either in online format or as personalized, onsite workshops. We also recommend which regulations are most vital to your organization, based on our work with hundreds of Life Sciences companies.
Our team includes industry experts who can interpret the regulations based on their own real-world experiences within Life Sciences companies. For example, UL's self-paced online regulatory courses focus on key topics addressed in these regulations, and are maintained as regulations change:
- GMP Regulations: 21 CFR Part 210, 211, 312, 820, EU ANNEX 15 and 16
- ISO Standards: ISO 13485, ISO 14971, ISO 16044
- Clinical Regulations: 21 CFR Part 312, EU Clinical Trial and GCP Directives
- Sales Compliance: FCPA, UK Bribery Act, Physician Payment Sunshine Act, OIG Regulations
Browse our UL Learn online knowledge base for available courses and educational programs.
The program includes five eLearning courses covering many enforcement issues related to Data Intgreity, targeted to professionals within QA, QC Lab and Clinical. Clients and also receive expertise and process improvements directly from our experts, who can visit facilities and demonstrate how to improve quality culture and embed data integrity into eveyday activities and procedures.