UL Course Update Portal

This page lists UL Compliance to Performance courses that are "New", or have received a "Major" or "Minor" update. "Major" updates include regulation changes, which should be retrained upon. The course update explanations below can assist you in deciding whether or not to assign retraining.

 

This portal provides a rolling multi-month history, and categorizes our courses into Life Science (GMP, Clinical, Compliance, Sales, etc.), Healthcare (Medicare Advantage, Part D, etc.), and General Industry (EHS, Ethics, Corporate Compliance, etc.).

 

If you have any questions about this course information, or would like information on previous course changes, please e-mail UL Client Services at prn.technologysupport@ul.com

 

Browse our UL Learn online knowledge base for available courses and educational programs.


 

 December 2017 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Major GCP29 Recruitment and Retention of Study Participants Life Science Clinical: Medical Device, Clinical: Pharmaceutical 2.0 Update to HHS regulations, 45 CFR part 46, “Common Rule” - the final rule enhancing human subject protections, revisions to Informed Consent Document, Local IRB and Advertising Material sections. 

 November 2017 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New Aseptic04 Isolators for Aseptic Processing Life Science Program Only - Aseptic Processing: Advanced Series 1.0 New title in the Aseptic Processing: Advanced Series Program. This course describes critical operating principles for the successful operation of an isolator for aseptic processing. Topics in this course include: Prepare, Leak Test, Decontaminate, Setup, Operate, Monitor, Clean, and Maintain. After completing this course, learners will be able to recognize the major process steps for isolator processing.
New Aseptic07 Dos and Don’ts of Aseptic Environments Life Science Program Only - Aseptic Processing: Advanced Series 1.0 New title in the Aseptic Processing: Advanced Series Program. This course introduces best practices for aseptic technique and behavior for use with conventional cleanroom aseptic processing. Topics in this course include: Dos and Don’ts (including Personnel Requirements, Gowning and Gloves, Cleanroom Integrity, Behavior, Critical Area Interactions, and Culture). After completing this course, learners will be able to recognize best practice aseptic behaviors and techniques as well as specific examples of what to do and what not to do in the cleanroom.
Minor EHS29 Fire Extinguishers General Industry Environmental Health and Safety 3.1 Content restructure, grammatical changes.
Minor EHS34 Forklift Safety General Industry Environmental Health and Safety 2.1 Content restructure, grammatical changes.
Minor EHS48 Hydrogen Sulfide (H2S) General Industry Environmental Health and Safety 2.1 Content restructure, grammatical changes.
Minor EHS56 Lead General Industry Environmental Health and Safety 3.1 Content restructure, grammatical changes.
Minor EHS57 Lockout/Tagout — Affected  General Industry Environmental Health and Safety 2.2 Content restructure, grammatical changes.
Minor EHS58 Lockout/Tagout — Authorized  General Industry Environmental Health and Safety 2.3 Content restructure, grammatical changes.
Minor EHS98 Walking and Working Surfaces – Affected Person General Industry Environmental Health and Safety 1.6 Content restructure, grammatical changes.
Minor GCP02 ICH GCP Obligations of Investigators Conducting Clinical Trials Life Science Clinical: Pharmaceutical  4.1 Content refinements in accordance with Step 4 version of ICH E6(R2).
Major LAV22 Harassment Avoidance Training for California General Industry Ethics & Corporate Responsibility  3.0 Updates to California law re-training requirements, include training and scenarios regarding gender identity and sexual orientation (SB-396).
Major PARTD08 Medicare Part D: Medication Therapy Management and Quality Improvement Program Healthcare Medicare Part D 7.0 Updates include incorporation of CMS guidance relating to the MTM program, adding a more detailed comparison to the most recent CMS guidance, corrected PDE requirements, inclusion of patient safety reports, STAR ratings, and updated quiz questions.
Major PHA81 Computerized Systems Inspections in the Pharmaceutical Industry Life Science FDA Inspections and Enforcement 4.0 Inclusion of GAMP 5 Risk Management guidance, tips on cybersecurity, and refinements to sections on 21 CFR Part 11. 

 October 2017 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor EHS18 DOT Hazardous Materials Training - General Awareness General Industry Environmental Health and Safety 3.1 Content restructure, grammatical changes.
Minor EHS67 Personal Protective Equipment General Industry Environmental Health and Safety 2.1 Content restructure, grammatical changes.
Minor FDA24 Recalls of FDA-Regulated Products Life Science FDA Inspections and Enforcement 2.2 Course format change to EduFlex, grammatical changes. 
Minor FDA25 Special Investigations Life Science FDA Inspections and Enforcement 2.1 Course format change to EduFlex, grammatical changes. 
Minor FDA38 Basics of Inspections: Beginning an Inspection Life Science FDA Inspections and Enforcement 1.2 Course format change to EduFlex, grammatical changes. 
Minor LAV04 Hiring and Firing General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management 1.2 Course format change to EduFlex, grammatical changes. 
Major MA36 Medicare Advantage: Plan Benefit Package and Bid Pricing Tool Healthcare Medicare Advantage 4.0 Summary of Benefits (SB) removed, as requirements have been updated, SB is no longer generated from the PBP software, Medicare Personal Plan Finder updated to Medicare Plan Finder, and PBP software screenshots updated. 
Minor OIG03 OIG Compliance Program Guidance for Medical Device Manufacturers – Field Force     Life Science Medical Device - Sales & Marketing 2.1 Clarification of distinction between kickbacks and illegal remuneration, inclusion of TRICARE, course format change to EduFlex, grammatical changes. 

 September 2017 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New Aseptic03 Principles of Restricted Access Barrier Systems and Isolators Life Science Program Only - Aseptic Processing: Advanced Series 1.0 New title in the Aseptic Processing: Advanced Series Program. This course introduces the basic principles of two specific types of improved aseptic processing: Restricted Access Barrier Systems (RABSs) and Isolators. Topics in this course include: RABS, Isolators, and Key Elements. After completing this course, learners will be able to recognize the basic attributes and functions of RABS and Isolators, identify regulatory requirements for these systems, and recognize key elements of each type of system.
Minor FDA22 Evidence and Proof Life Science FDA Inspections and Enforcement 1.3 Course format change to EduFlex, grammatical changes. 
Minor FDA23 Sample Collection Life Science FDA Inspections and Enforcement 1.3 Course format change to EduFlex, grammatical changes. 
Minor FDA28 Field Examinations Life Science FDA Inspections and Enforcement 1.3 Course format change to EduFlex, grammatical changes. 
Minor FDA39 Basics of Inspections: Issues and Observations Life Science FDA Inspections and Enforcement 1.2 Course format change to EduFlex, grammatical changes, update to Inspection Report content. 
Major GCP02 ICH GCP Obligations of Investigators Conducting Clinical Trials Life Science Clinical: Pharmaceutical 4.0 Incorporate ICH E6(R2).
Minor GCP06 Overview of the Preparation Requirements for the ICH Common Technical Document  Life Science Clinical: Pharmaceutical 1.2 Course format change to EduFlex, grammatical changes. 
Minor GCP17 The Role of the Clinical Research Associate Life Science Clinical: Medical Device, Clinical: Pharmaceutical 1.5 Incorporate ICH E6(R2). Course format change to EduFlex, grammatical changes. 
Major GCP21 Clinical Trial Audits and Consequences of Noncompliance Life Science Clinical: Medical Device, Clinical: Pharmaceutical 3.0 Incorporate ICH E6(R2).
Major GCP24 Financial Disclosure by Clinical Investigators Life Science Clinical: Medical Device, Clinical: Pharmaceutical 3.0 Inclusion of Physician Payment Sunshine Act, update to required disclosures for NIH-funded studies, grammatical changes. 
Minor GCP26 Administrative Roles of the Clinical Research Associate Life Science Clinical: Medical Device, Clinical: Pharmaceutical 1.3 Incorporate ICH E6(R2), revised to remove overlap content from GCP17 to appropriately address role of the CRA, and nomenclature change of patient to subject. 
Major MAPD03 MAPD/PDP: Marketing Healthcare Medicare Advantage
Medicare Part D
9.0 Update to reflect 2018 CMS marketing guidelines. 
Major PARTD07 Medicare Part D: Pharmacy Network Healthcare Medicare Part D 3.0 Update to Preferred Pharmacy Cost Share Access Guidance, addition of Part D vaccines, cost sharing, and CMS audit information. 

 August 2017 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Major EHS112 DOT Hazardous Materials Training — Carrier Requirements (Highway) General Industry Environmental Health and Safety 3.0 “Keeping Shipping Papers” chapter revised to contain up-to-date content; including documentation requirements, retention policy based upon medium, and availability requirements for formal requests. 
Major EHS47 Hot Work Permits General Industry Environmental Health and Safety 3.0 References to "Covers for Flammable Materials" updated to "Covers for Combustible Materials". Requirements for Hot Work Permits within measurable designated areas reflect current requirements. 
New ETHICS24 Accurate Company Records General Industry Ethics & Corporate Responsibility 1.0 This course is a replacement for RH0001 Accurate Company Records. Grammatical and stylistic updates. 
Minor PARTD03 Medicare Part D: Bid and Benefit Package Healthcare Medicare Part D 3.1 2016 data updated to 2017 data, including deductible level and coverage gap dollar amounts. 
Minor DEV53 Medical Device Filings: 510(k), PMA, and IDE Life Science Medical Device GMPs, Global Regulatory 1.2 Grammatical and editorial edits including clarified objectives, statement explaining FDA may update device classifications, and recognition of the pre-submission pathways to communicate with the FDA.
Minor FDA21 FDA Good Guidance Practices (GGPs) Life Science FDA Inspections and Enforcement 1.2 Course format change to EduFlex, grammatical changes. 
Major FDA32 FDA Establishment Inspection (EI) Life Science FDA Inspections and Enforcement 2.0 Course format change to EduFlex, grammatical changes. 
Major GCP22 Aspects of Regulatory History Life Science Clinical: Medical Device, Clinical: Pharmaceutical 3.0 Inclusion of "Final Rule" under HHS, admendment to the Common Rule under OHRP and HHS, introduction to broad consent, reduced IRB administrative burden, and additional protections for vulnerable populations.
Minor GCP28 The Clinical Development Process: Investigational Product, Plan, and Data Management Life Science Clinical: Medical Device, Clinical: Pharmaceutical 2.1 Incorporate additional responsibilities of the sponsor, monitor, and investigator as reflected in ICH E6 (R2). Also includes clarification of patients as Clinical Trial participants and the centralized, risk-based techniques of Clinical Trial monitoring.
Minor ICHreg03 Documenting the Drug Development Process (ICHQ8) Life Science Global Regulatory 2.1 Course format change to EduFlex and reflects revised FDA guidance on Q8(R2). 
Minor ICHreg05 Q9: Quality Risk Management Life Science Global Regulatory 2.1 Course format change to EduFlex, grammatical changes. 
Major MDSM05 Introduction to Medical Device Health Care Compliance Life Science Medical Device - Sales & Marketing 2.0 Update reflects current AdvaMed Code of Ethics guidelines including off-label information requests. Examples/case-studies refined to provide further context around Anti-Kickback violations. 
Minor PHSM08 Postmarketing Reporting of Adverse Drug Experiences Life Science Pharmaceutical - Sales & Marketing 1.2 Example/case-study updates, references to postmarket reporting updated to postmarketing reporting, and requirements for foreign event submissions via Form 3500. 

 July 2017 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor PARTD01 Medicare Part D: Administration and Management Healthcare Medicare Part D  2.1 Course format change to EduFlex. Added detail on administration and management, basic HIPAA requirements, more information on requirements for Compliance Program, reporting requirements, and sponsor contract requirements.
Minor PHA71 Complaint Management for Pharmaceutical Manufacturers Life Science Pharmaceutical GMPs  1.1 Course format change to EduFlex, grammatical changes. 
Minor PHA42 Meeting Process Requirements for Returned and Salvaged Drug Products Life Science Pharmaceutical GMPs 1.3 Course format change to EduFlex, grammatical changes. 
Major MDR01 EU Medical Device Regulation (MDR) Life Science Medical Device GMPs, Global Regulatory 2.0 Courses have been rewritten and format change to EduFlex. MDD (Medical Device Directive) has been updated to MDR (Medical Device Regulation). The European Parliament approved final versions of the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). MDR01 provides introductory information pertaining to the European Medical Device Regulation and CE Marking of Medical Devices and MDR02 provides introductory information pertaining to the European Union (EU) In Vitro Medical Device (IVDR). MDR will become applicable in Europe in 2020, while the IVDR will become applicable in 2022.
Major MDR02 EU In Vitro Diagnostic Regulations (IVDR) Life Science Medical Device GMPs, Global Regulatory 2.0