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 serves as a guide to ISO 9001:2015, the international quality management system requirements standard. This standard specifies requirements to demonstrate an organization’s ability to consistently provide products and services that meet customer satisfaction and applicable statutory and regulatory requirements. Topics in this course include: System and Process, Leadership, Planning, Support, Operation, Performance Evaluation, and Improvement. After completing this course, learners will be able to recognize the specific requirements of ISO 9001:2015 and identify management’s role in implementation and maintenance of the standard. Learners will also be able to recognize the requirements for quality management system Clauses 4-10 and recognize how to ensure compliance with the standard.
Age discrimination can be particularly challenging when an employer is reducing employee numbers or is managing an aging workforce. This course describes the federal legislation that prohibits age discrimination in the workplace. Topics in this course include: Legislation, Prohibited Practices, Claims, and Helpful Strategies. After completing this course, learners will be able to recognize provisions of the Age Discrimination in Employment Act (ADEA).
The course identifies who is classified as a disabled employee and how these employees are protected under the Americans with Disabilities Act (ADA). This course also discusses the concepts of reasonable accommodation and undue hardship as well as coverage for substance abuse. Topics in this course include: Disability, Legislation, Reasonable Accommodation, and Drugs and Alcohol. After completing this course, learners will be able to recognize who is classified as a disabled employee and how the ADA protects these individuals. Learners will also be able to recognize how to comply with the ADA reasonable accommodation requirement.
The international standard ISO 13485:2016 specifies the requirements for a quality management system that can be used by an organization in one or more stages of the life-cycle. ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. This course is the first of a two part series. Topics in this course include: ISO 13485:2016, Process Approach, Clauses 4-6, Clauses 7 and 8, and Preparation. This course also addresses specific aspects of ISO 13485 as it relates to the European Union (EU). After completing this course, learners will be able to recognize the requirements of ISO 13485.
Compliance with current Good Manufacturing Practices (cGMP) requirements is essential in order to create products that have quality, purity, proper identity, strength, and are safe and effective. All laboratory analysts must follow cGMPs in order to create effective products and comply with all quality standards. Topics in this course include: Laboratory Documents, Laboratory Practices, Raw Data, Method Validation, Calibration, Training, OOT and OOS, and Laboratory Information Management Systems (LIMS). After completing this course, learners will be able to identify cGMP requirements as they apply to analytical laboratory practices.
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.