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.
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.
Documentation is an essential part of Good Manufacturing Practice (GMP). This course provides an overview for manufacturers of pharmaceutical and biological products of the documents required and the controls that should be in place. The regulatory requirements of FDA are addressed with reference also made to the requirements of the EU. The course provides an introduction to staff at all levels and highlights the personal responsibility they have for ensuring documentation is followed and documentation is correct. Topics in this course include: Regulatory Requirements, Instructional Documents, Records, Control, Electronic Documentation, and Good Practices. After completing this course, learners will be able to recognize the importance of good documentation practices.
This course will provide you with a working knowledge of informed consent regulations, Institutional Review Board / Independent Ethics Committee responsibilities, and the obligations of the individuals responsible for protecting patient rights and welfare.
