FDA Inspection and Enforcement Course Guide
2.78 MB
In-depth GxP and FDA compliance training libraries
UL Solutions offers over 1,000 standard regulatory and performance-focused e-learning courses. Many of the GxP/FDA compliance courses were authored or reviewed by the U.S. Food and Drug Administration (FDA). Course catalogs can be delivered integrated with ComplianceWire® instances, or on a standalone basis in SCORM or AICC formats. Libraries include:
- Aseptic Processing Library
- Clinical: Medical Device Library
- Clinical: Pharmaceutical Library
- Data Integrity Library
- Dietary Supplements Library
- EHS for Life Science Library
- Ethics and Corporate Responsibilities Library
- FDA BIMO Library
- FDA Inspection and Enforcement Library
- Global Regulatory Library
- HR Compliance and Risk Management Library
- MDSAP Library
- Medical Device GMP Library
- Medical Device Sale and Marketing Library
- Pharmaceutical GMP Library
- Pharmaceutical Sale and Marketing Library
Content updates are included as standard in content license agreements. UL Solutions continually monitors and analyzes regulatory agencies and related information sources for incorporation into course updates or new courses. Many courses are available in multiple languages. All courses are in a mobile-learning format and can be taken on a desktop or tablet.
Explore a selection of our most popular courses
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Featured course
Every quarter we will feature a different course from our library. This is our current featured course.
Why is this course the feature of the quarter?
Overview of UKCA, UKNI, and CE Markings for Medical Devices (DEV66)
The withdrawal of the United Kingdom (U.K.) from the European Union (EU) on Jan. 31, 2020, triggered regulatory changes to the requirements for placing medical devices on the market in the U.K. Beginning Jan. 1, 2025, the UKCA (U.K. Conformity Assessed) marking, which is the new U.K. product marking, will be mandatory for the majority of the products being placed on the market in Great Britain (England, Wales, and Scotland), replacing the CE marking.
This course will help medical device organizations understand information about the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the UKCA, UKNI, and CE markings for medical devices. Topics in this course include MHRA, marking requirements, and conformity assessment. After completing this course, learners will be able to identify directives and regulations that apply to medical devices sold in the U.K. Learners will also be able to differentiate between the U.K. medical device markings.
“We are committed to delivering and maintaining regulatory accurate eLearning courses which are instructional sound and visually engaging.”
Effective approaches to learning engagement
We incorporate a variety of approaches to convey content to the learner in a meaningful manner. Below are some of the methods we use to capture our learners' interest.
Topic specific videos
Courses can also include dnamic videos to compliment the course content. Topics are portrayed through eye-catching videos helping to bring the content to life.
Avatar Videos
Avatar videos use a computer generated character that will introduce the content. This animated host will add interest and a personal touch to the information being delivered.
Stepper interactions
The stepper interaction allows you to navigate through content in sequential order. It is great for procedures with steps or timelines.
Vyond Videos
Dynamic content can make all the difference in creating a video that leaves a lasting impact. We can create dynamic videos for any situation. Mix multiple styles, create custom characters for any setting or job role then bring them to life with realistic movement, actions, and automatic lip-sync.
Quiz Interactions
To ensure your users have retained the knowledge in the courses, test them with assessments that can be added throughout. You can use multiple choice, true or false and matching.
Training you can access anywhere, anytime
UL Solutions' unique web-based eLearning assets
Our professional development education programs carefully target the diverse needs of learners, regardless of industry, language, culture or education:
- FDA-authored and/or reviewed courses identical to those used by the FDA to train its inspectors and investigators.
- Standardized courses on issues regulated by the International Conference on Harmonization (ICH); and by federal agencies, including Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS).
- Curricula focused on critical workplace subjects ranging from employee confidentiality to sexual harassment, health and safety and data integrity.
- Customized, client-specific courses including:
- Code of conduct
- Corporate culture
- Industry-specific regulations
Empowering employees with knowledge and expertise
Your organization’s greatest competitive advantage, aside from your employees, resides in your efficient communication of knowledge and procedures to drive measurable results.
The world’s leading companies recognize the intrinsic value and cost-efficiency of transforming critical procedures and processes into expert-developed solutions in the form of online LMS training courses, to instill product knowledge and deliver service consistently to employees, contractors, and suppliers.
From pharmaceuticals, medical devices and biologics to data integrity and ethics, we provide training solutions that engage employees, build knowledge retention and help provide measurable business results.
Web-based employee training has never been more easily accessible with our continuously updated premium-content library, available to customers on our exclusive compliance-based LMS.
Have your own LMS? UL Solutions courses are SCORM-and AICC-conformant.
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