Regeneron Pharmaceuticals, Inc.
Founded in 1988, Regeneron is a biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes new medicines. Their pursuit has one singular intent – to improve therapeutic outcomes for patients.
The organization’s intent was to roll out a complex, blended curriculum to all operations personnel and manufacturing lines and stations, track qualifications per FDA regulations, provide automated reporting, and fully integrate the Learning Management System (LMS) with the current document management system. These complex curricula included traditional instructor-led training, standard operating procedures (SOPs), assessments, on-the-job (OJT) training, and manager / trainer checklists. Additionally, each portion of the curriculum matrix was mapped to a list of specific Jobs and Job Roles at Regeneron. The initial qualification training was to be rolled out to approximately 400 users while ongoing re-qualification would be necessary when a course or document was edited or revised. This time sensitive re-qualification process required the use of notifications and other system alerts to the targeted audience, training administrators, and quality personnel. Additionally the organization wanted to take advantage of the LMS’ e-Signature,
approval, and auditing functionality.
rapidLD consultants were engaged to:
- Ensure proper integration of the document management system with the LMS
- Implement and configure the LMS to suit client’s business requirements
- Support the validation of the LMS that was to be rolled out in a six (6) month time frame
- Assist in the development of the qualification structure and use of learning plans
- Align system capabilities with business requirements / processes
- Phase 1 of the project was completed successfully on time and within budget
- Validated against the FDA’s CFR 21 Part 11 & Part 820
- rapidLD was invited to lead Phase 2 resulting in additional validation efforts and custom reporting