Life Science

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.

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Application of GMPs to Microbiology Laboratories

This program addresses the application of GMP principles to microbiology laboratories and discusses the general principles of GMPs and their importance in microbiology laboratories. Aspects of laboratory operations specifically required by GMPs and considered industry practice will be reviewed, including: general GMP requirements for microbiology laboratories, documents and document control, handling of raw data, and laboratory control. Coverage of general laboratory control issues will be the focus of the program and cover GMP requirements for topics, such as: handling of chemicals, documentation practices, sample handling, prevention of cross-contamination, positive and negative controls, identification tests, sterility tests, handling of media, laboratory equipment, autoclaves, and environmental monitoring. This will be an excellent overview of specific laboratory requirements.
$99.95

Approach to Computerized Systems Validation and Compliance

This course describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices that are required to meet FDA’s regulations. It outlines the kind of organization, policies and procedures, and plans FDA expects a manufacturing company to establish. This course draws on current industry good practice. Though it also draws on FDA medical device guidance, this course is not intended to describe an approach to developing software that subsequently becomes part of a medical device. This is the second course in a series of four courses. Before taking this course, you should have successfully completed Requirements for Computerized Systems Validation and Compliance.
$99.95

Aspects of Regulatory History

This course will provide an overview and summary of the regulatory requirements per Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) necessary to ensure proper and successful clinical trial execution. Review of ICH will also provide you with an understanding of its impact on the industry from a global perspective.
$24.95

Awareness of FDA Inspections for Pharmaceutical Manufacturers

In this course, you will be provided with a general awareness of FDA inspections of pharmaceutical testing and manufacturing facilities, including purpose, types, and areas/operations typically inspected. You will also explore how firms should handle FDA inspections and interact effectively with FDA Investigators.
$99.95

Awareness of FDA Inspections for Pharmaceutical Manufacturers

This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.
$99.95

Awareness of FDA Inspections for Pharmaceutical Manufacturers (Chinese)

This course covers the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also discusses how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators. Topics in this course include: Scope, Inspection Types, Initiation, Handling Inspections, Inspection Coverage, FDA Interaction, and Closeout. After completing this course, learners will be able to identify the basics of FDA inspections of drug manufacturing facilities and how firms should handle FDA inspections and interact effectively with Investigators.
$99.95