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 will explore the role of the clinical research associate (CRA) in monitoring a clinical trial and acting as a liaison between the investigative site and the sponsor company. The course will introduce key CRA responsibilities widely recognized throughout the industry and globally applicable. The CRA’s role during pre-study, initiation, interim and closure visits will be examined, as will the CRA’s involvement in addressing noncompliance when observed. Finally, the course will conclude with a look at emerging trends affecting the industry’s CRA resources.
This course will explore the role of the clinical research coordinator (CRC) in executing a clinical trial and acting as a liaison to the investigator, sponsor, and monitor. The course will introduce key CRC responsibilities at the site, including subject recruitment, informed consent, source document and CRF completion, and test article accountability. The CRC’s role during site visits, including pre-study, initiation, interim and closure, will be examined.
This course covers the definition and purpose of post-approval changes. In addition, it explores the four categories of change: Components and Composition, Scale of Manufacture, Site of Manufacture, and Manufacturing, and the requirements for each level of change. In this course, you will learn about PAC guidance and how these documents are used to provide notification to FDA for post-approval changes to an approved drug application. You will examine the levels of PAC and the recommended chemistry, manufacturing, and control (CMC) requirements for each level. You will also explore the categories of change. Finally, you will be able to identify the tests and documents needed for each level and category of change.
Recently FDA has become increasingly concerned with the number of Warning Letters being issued due to problems with the control of manufacturing processes. Items listed in these various Warning Letters include lack of validation of manufacturing processes, lack of written procedures, improper sampling and testing of materials, and failure to follow written procedures. This course provides an understanding of what process control is. You will also learn about the written procedures involved in validation, how equipment affects process controls, batch production records, correct sampling and testing methods, proper reprocessing techniques, contamination control, change control, and process analytical technology.
This course introduces developers and those individuals involved in validation of analytical methods to the regulatory requirements for the validation of analytical laboratory procedures. After taking this course, you will be able to identify the purpose and benefits of validation, determine when validation is necessary, and recognize common approaches to these activities.
This course provides the learner with the information that should be included in a validation protocol. The learner is introduced to the key components of the protocol, such as information related to materials, equipment, and acceptance criteria. This course is an introduction to the importance and content of the documentation that comprises validation. After completing this course, the learner will understand what validation protocols are. The learner will also be able to identify the three types of qualifications, as well as the properties of each qualification. The learner will also be able to describe the key elements involved in a validation protocol.