UL PURE™ Learning has partnered with corporate and government clients in the Life Science, Health Care, Energy and General Industry markets for over 30 years.
We currently maintain more than 500 eLearning courses that are written and reviewed by recognized subject matter experts, including the USFDA. In fact, more than 1 million industry professionals, including over 36,000 FDA investigators, have completed over seven million courses since 2003. Courses are regularly updated to reflect the most current expectations and requirements of regulators and industry groups. Our global qualityand compliance management methodology has resulted in measurable performance and compliance improvements.
Our eLearning philosophyis based on Mastery Learning, which has been proven to improve retention and change behavior in adult learners through methods thatinclude interaction with dynamic content and built-in assessments.
This course describes sponsor and monitor requirements and responsibilities for the conduct of clinical trials in support of new drug and biologics applications. Topics in this course include: Sponsor’s Role, Records and Documentation, Research Team, Investigator Oversight, Pre-Trial Monitoring Visit, Other Visits, and Monitor Activities. After completing this course, learners will be able to recognize the roles and responsibilities of sponsors and monitors during clinical trials.
This course addresses the roles and responsibilities of personnel during an FDA inspection. Topics in this course include Personnel Conduct, Inspection Types, Process, Records, Photos and Samples, Concluding an Inspection, and Enforcement. After completing this course, learners will be able to identify the basics of handling an FDA Good Manufacturing Practice (GMP) inspection.
In many organizations today, electronic records and electronic signatures are becoming more common. This course identifies how to implement Part 11 and what it means in terms ofFDA's enforcement policy for 21 CFR Part 11, Electronic Records; Electronic Signatures. Topics in this course include: Meeting Expectations, Records, Security, Electronic Signatures, System Documentation, and Audit Trails. After completing this course, learners will be able to recognize how to apply Part 11 regulations to your company's systems and records in accordance withFDA's expectations.
