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.
Demonstrating the “nuts and bolts” of process validation, this program outlines the important tasks performed during each phase of the validation life cycle. You'll learn what type of information should (and should not) be included in validation documents and why processes must be monitored once they are validated.
FDA-regulated industries must work closely with FDA to comply with industry regulations and create safe and effective products. But how well do your employees know FDA? “A Tour of FDA” serves as an excellent introduction to the organizational structure of FDA and gives an overview of the different enforcement actions available to this critical Agency. Take a virtual ‘tour’ of FDA, learning about the function of each Center along the way. Afterwards, explore different actions the Agency may take in order to achieve compliance.
Health Canada touches the lives of virtually every Canadian, every day. This special tour introduces participants to Health Canada's mission and organization. After the brief introduction, the tour will focus on the Health Products and Food Branch (HPFB) of Health Canada, which directly affects pharmaceutical manufacturers.
The system in Europe for ensuring safe, effective, and high-quality health products is composed of national authorities in individual countries as well as bodies in the European Union and the Council of Europe. After completing this course, participants will know the organisations that oversee the health industry in Europe and the bodies in those organisations that affect pharmaceutical companies. In addition, participants will know the ways health products can be approved for sale to the public and the system for reporting and tracking defective products.
Listening is one of the most important skills for success in life, but it is taken for granted by most people. In this course, participants will learn how to improve their active listening skills, and gain an understanding of the significance of listening. Practicing the seven listening skills presented will help participants increase their productivity, as well as improve their ability to work with others.
The purpose of this course will be to examine the administrative roles and responsibilities of the Clinical Research Associate (CRA) specific on-site monitor visits conducted at the principal investigator location on behalf of a sponsor. The term “CRA” can be used synonymously and interchangeably with “monitor” in this course instruction. This course will be limited to the discussion of the on-site monitoring role of the CRA and required pre- and post- site visit responsibilities.