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 is targeted for personnel performing a quality assurance function. In this course, we will define batch records and describe how to properly perform a batch record review. In addition, the course will cover the cGMP requirements for batch records and address how to maintain cGMP compliance throughout the review process.
This is the second in a series of courses that provide an overview of FDA’s Bioresearch Monitoring (BIMO) program and the methods and techniques used in conducting and reporting Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor, and in vivo Bioequivalence inspections. This course provides an overview of the general inspection assignment process, site selection, background materials used in a BIMO inspection, and regulatory consequences of the BIMO program.
This course provides on overview of the fundamental compliance issues impacting the biotechnology industry. It examines compliance requirements specific to the biotechnology processes such as: cell culture and fermentation; culture media and growth; antibody production; extraction, isolation, and purification; cleaning procedures; and laboratory controls and testing.
This course provides all employees and associates with knowledge of the privacy and security practices for health plans, as required by the Health Insurance Portability and Accountability Act (HIPAA). This course includes updated requirements that were included in the Health Information Technology for Economic and Clinical Health Act (HITECH). Employees will learn the basic principles of health information privacy and security, how they impact the organization, and how they apply to everyday work situations. The course also covers patients' rights under HIPAA, and the consequences for violating privacy and security practices.