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 explores ways to assess the effectiveness of meetings and skills to enhance the meeting process. Topics in this course include: Purpose, Meeting Costs, Key Steps, and Prepare. After completing this course, learners will be able to recognize how to lead meetings, accomplish goals, and follow up to ensure success.
The success of any meeting is largely determined by the leadership skills of the key participants. This course discusses the leadership skills necessary to conduct successful meetings. Topics in this course include: Start, Lead, Goals, Common Problems, Conflict, and Finish. After completing this course, learners will be able to recognize how to effectively set up, kickoff, conclude, and follow up a meeting. Learners should take Making Meetings Work I: Purpose and Preparation prior to taking this training.
As workforce numbers shrink, and individuals are called to interact more intensely with fewer people, the ability to manage conflict effectively becomes more important. This course identifies appropriate responses to conflict. Topics in this course include: Conflict Resolution Styles, Selecting Styles, Collaboration Guidelines, and Application. After completing this course, learners will be able to successfully approach and resolve conflict in the workplace.
This course will help team leaders and team members to understand the process of moving from a hierarchical structure and mindset to a more team-oriented approach. Topics in this course include: Differences, Model, Transition, Vision, Coaching, and Example. After completing this course, learners will be able to recognize how to transition successfully from a top-down management approach to one in which team members work together to achieve greater results than could be achieved individually.
This course describes the premarket approval and notification processes for medical devices in the US. Topics in this course include: FDA Authority, Classification, Premarket Notification, Premarket Approval, IDE, and Compliance. After completing this course, learners will be able to identify the essential elements of the 510(k), premarket approval (PMA), and Investigational Device Exemption (IDE) filing processes for medical devices under FDA.
Mistakes or mix-ups in the critical areas of product packaging, labeling, and distribution can pose a danger to the consumer. This course provides you with information on current packaging and labeling requirements specified by the Quality System Regulation. A basic understanding of quality system regulations for medical device and equipment manufacturers (21 CFR 820), quality control procedures, and quality principles are prerequisites for this course. Topics in this course include: Importance of Labeling, Packaging, Label Control, and Distribution. After completing this course, learners will be able to recognize the requirements for packaging, labeling, and distribution of medical devices 21 CFR 820.120-160.
