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 examines the administrative roles and responsibilities of the Clinical Research Associate (CRA) during specific on-site monitor visits conducted at the principal investigator location on behalf of a sponsor. Topics in this course include: Roles and Responsibilities, Monitoring Plan, PSSV and SIV, Source Documents, and Monitoring Functions. After completing this course, learners will be able to identify the general roles and responsibilities of a CRA, with recommended monitoring tasks to be completed at specified time intervals of an ongoing study.
This course focuses on the responsibilities of sponsors and monitors of clinical research involving unapproved test articles under the jurisdiction of FDA. Topics in this course include: Responsibilities, Applicable Regulations, Compliance Program 7348.810, Strategy, Inspectional Elements, Additional Elements, Potential Outcomes, and Regulatory Actions. After completing this course, learners will be able to recognize the roles and responsibilities of both sponsors and monitors in conducting clinical trials and use that knowledge to conduct inspections successfully in the BIMO program.
Sponsors can put measures in place in an attempt to dissuade researchers from being noncompliant, but those measures are only as effective as the personnel applying them. This course will provide a description of the clinical trial audit process and how audits help to ensure trials are conducted in accordance with regulatory requirements. Topics in this course include: Clinical Trial Audit, FDA Inspection, and Noncompliance. After completing this course, learners will be able to identify FDA standards for conducting and reporting clinical site inspections, as well as recognize FDA's system for classifying inspections and taking corrective action.
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, Research Team, Investigators, Prestudy Site Visit (PSV), Other Visits, and Monitoring 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.
