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.

 

 September 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor EHS06 Basics of Business Finance General Industry HR Compliance & Risk Management 1.3 Course update to EduFlex, grammatical changes. 
Minor EHS60 Making Meetings Work I: Purpose and Preparation General Industry HR Compliance & Risk Management 1.2 Course update to EduFlex, grammatical changes. 
Minor EHS66 Personal Leadership Power General Industry HR Compliance & Risk Management, Ethics & Corporate Responsibility 2.3 Course update to EduFlex, grammatical changes.
Major MA34 Medicare Advantage: Provider Compliance Healthcare Medicare Advantage 5.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MA38 Medicare Advantage: Claims Processing Healthcare Medicare Advantage 5.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MA41 Medicare Advantage: Quality Management and Utilization Management Healthcare Medicare Advantage 6.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major PARTD03 Medicare Part D: Bid and Benefit Package Healthcare Medicare Part D 4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major PARTD07 Medicare Part D: Pharmacy Network Healthcare Medicare Part D 4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major PARTD10 Medicare Part D: Coordination of Benefits and True Out-of-Pocket Facilitation Healthcare Medicare Part D 7.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MAPD04 MAO/PDP: Compliance Program Guidelines Healthcare Medicare Part D 4.0

Removal of general compliance training requirement for FDR's.

New MAPD_MIC02 Member Issue Classification - Part C Healthcare  Premium Content Only 1.0

New Course Offering. This course covers real-life scenarios and requires learners to apply knowledge of Medicare Advantage Organization (MAO) procedures in order to classify Part C member issues appropriately. Topics in this course include: Member Issues. After completing this course, learners will be able to identify the correct classification of member issues based on a brief summary of each situation.

New MAPD_MIC03  Member Issue Classification - Part D Healthcare  Premium Content Only 1.0

New Course Offering. This course covers real-life scenarios and requires learners to apply knowledge of procedures in order to classify member Part D issues appropriately. Topics in this course include: Member Issues. After completing this course, learners will be able to identify the correct classification of member issues based on a brief summary of each situation.

 August 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New DEV64 Canadian Medical Device Regulations Life Science Global Regulatory, Medical Device GMPs 1.0

New Course Offering. This course introduces the Canadian medical device regulations. This course identifies the scope and applicability of the Canadian Medical Devices Regulation (CMDR) that was last amended on February 13, 2017. Topics in this course include: Regulatory Agencies, Definition, Medical Device Licensing, Post Approval, and CMDR vs ISO 13485. After completing this course, learners will be able to identify the requirements to market devices in Canada.

Minor EHS64 Managing Transitions to Teams General Industry HR Compliance & Risk Management 1.3 Course update to EduFlex, grammatical changes. 
Minor EHS94 Self-Motivation General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management  1.3 Course update to EduFlex, grammatical changes. 
Minor ETHICS15 Privacy and Data Protection General Industry Ethics & Corporate Responsibility 3.1 Inclusion of GDPR. 
New LAV23 Sexual Harassment Awareness for New York Employees and Supervisors General Industry HR Compliance & Risk Management, Ethics & Corporate Responsibility 1.0 New Course Offering. Sexual harassment is a serious issue facing employers. This course is designed to educate you about New York & federal laws regarding sexual harassment as well as to present information on identifying harassing behavior, avoiding harassment, and what steps to take should harassment issues arise involving the workplace. Topics in this course include: Guidelines, Confrontation, Reporting Incidents, Supervisor Responsibilities, and Rights and Remedies. Learners will be able to recognize that harassment is a personal issue and that definitions of offensive behavior may differ amongst coworkers. Learners also will be able to identify behaviors that are considered inappropriate and recognize how to avoid engaging in inappropriate behaviors. 
Major MA28 Medicare Advantage: Member Services Healthcare Medicare Advantage 8.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MA29 Medicare Advantage: Overview of the Medicare Program Healthcare Medicare Advantage  4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MAPD01 Medicare Health Plan and PDP: Fraud, Waste, and Abuse Healthcare Medicare Advantage, Medicare Part D 4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
New MAPD_MIC01 Member Issue ClassificationTraining Healthcare Premium Content Only 1.0

New Course Offering. This course provides an overview of the different types of member issues to provide Call Center, Appeals and Grievance, Utilization Management, and Pharmacy staff with guidance on how to appropriately classify the issues so that they are handled under the appropriate procedure(s). Topics in this course include: Importance, Types of Member Issues, Multiple Processes, and Copays. After completing this course, learners will be able to identify the key terms used by CMS related to inquiries, grievances, organization determinations, and appeals. Learners will be able to recognize the types of member issues that are classified in these categories. Learners will also be able to recognize how to apply this knowledge to member issues so they can be handled by the appropriate department.

 July 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Major GHC02 HP: Compliance Program General Session Healthcare Healthcare: General 4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major GHC04 Fraud and Abuse Awareness Healthcare Healthcare: General 4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MA35 MAPD: Risk Adjustment and Data Validation Healthcare Medicare Advantage 4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MA36 Medicare Advantage: Plan Benefit Package and Bid Pricing Tool Healthcare Medicare Advantage 5.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MAPD02 MAPD: Enrollment Healthcare Medicare Advantage 8.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MAPD03 MAPD/PDP: Communications and Marketing Healthcare Medicare Advantage 10.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MDR03 CE Certification for Medical Devices  Life Science Medicare Device GMPs, Global Regulatory 2.0 Update to reflect final rule of EU MDR.
Major PARTD01 Medicare Part D: Administration and Managements Healthcare Medicare Part D 3.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major PARTD05 Medicare Part D: PDP Enrollment Healthcare Medicare Part D 10.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Minor PHDV72 Application of cGMPs to Microbiology Laboratories  Life Science Pharmaceutical GMPs 3.0 Update for 21 CFR 211 Part 160 - calibration procedures, Data Integrity guidance, EU guidance, and cGDP for laboratories. 

 June 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Major ADVAMED-MINI-02 AdvaMed Guidance: Modest Meals  Life Science Medical Device - Sales & Marketing 2.0 Update regarding applicability to transparency requirements.
Minor EHS63 Managing Job Stress General Industry HR Compliance & Risk Management 2.1 Course update to EduFlex, grammatical changes.
Minor EHS99 SMART Goal Setting General Industry HR Compliance & Risk Management 1.4 Course update to EduFlex, grammatical changes.
Major LAV03 Fair Labor Standards Act (FLSA) and Equal Pay Act (EPA) General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management 5.0 Rewrite refocusing on content relevant to the learner. 
Major MA27 Medicare Advantage: Administration and Management  Healthcare Medicare Advantage 5.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MA34 Medicare Advantage: Provider Compliance  Healthcare Medicare Advantage 4.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major MA37 Medicare Advantage: Grievances, Organization Determinations, and Appeals Healthcare Medicare Advantage 8.0 Updates pertaining to Contract Year 2019 Final Rule and Call Letter.
Major PARTD02 Medicare Part D: Grievances, Coverage Determinations and Appeals Healthcare Medicare Part D 7.0 Updates pertaining to Contract Year 2019 Final Rule for Medicare Advantage and Part D.
Major PARTD08 Medicare Part D: Medication Therapy Management and Quality Improvement Program     Healthcare Medicare Part D 8.0 Updates pertaining to Contract Year 2019 Final Rule.
Major PHA63 Gowning for Sterile Manufacturing Life Science Medical Device GMPs, Pharmaceutical GMPs, Global Regulatory 3.0 Added additional detail on contamination control, sections for gown and glove replacements requirements and gowning qualification, and updated case studies and graphics.
Minor QSR07 QS Regulation 7: Corrective and Preventive Action Life Science FDA Inspections and Enforcement, Medical Device GMPs 1.3 Updates in accordance with 21 CFR 820. 

 May 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New Aseptic06 Media Fills for Aseptic Processing Life Science Program Only: Aseptic Processing: Advanced Series 1.0 New title in the Aseptic Processing: Advanced Series Program. Media fills allow manufacturers to evaluate if their aseptic processes are capable of reliably producing sterile products that are free from contamination and are safe and effective for patients. This course describes the process of designing and executing media fills. Topics in this course include: Purpose and Design, Study Considerations, Execution, and Monitoring and Results. After completing this course, learners will be able to recognize the purpose of a media fill. Learners will also be able to identify the elements to consider while designing a media fill.
Major DEV43 Introduction to the Quality System Regulation (QSR) Life Science FDA Inspections and Enforcement, Med Device GMPs 3.0 Case Study update, regulation updates to 21 CFR Part 820. 
New DEV61 A Guide to ISO 9001:2015 — Quality Management Systems Requirements Life Science Med Device GMPs 1.0 New course offered in the Med Device GMPs library. 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 include: System and Process, Leadership, Planning, Support, Operation, Performance Evaluation, and Improvement. Learners will be able to recognize the specific requirements of ISO 9001:2015 and identify management’s role in implementation and maintenance. Learners will also be able to recognize the requirements for quality management system Clauses 4–10 and how to ensure compliance with the standard. 
New DEV62 Introduction to the Medical Device Single Audit Program (MDSAP) Life Science Medical Device GMPs 1.0 New course offered in the Med Device GMPs library. This course introduces the Medical Device Single Audit Program, which conducts audits of medical device manufacturers that satisfy the relevant requirements of five regulatory authorities participating in the program as well as those of ISO 13485:2016. Topics in this course include: Program, Audit Types, Structure, and Nonconformity Grading and Audit Responses. After completing this course, learners will be able to recognize the structure of the MDSAP as well as grading and follow-up requirements.
New DEV63 Brazil’s Technical Regulations for Medical Devices: RDC 16/2013, 67/2009, and 23/2012 Life Science Medical Device GMPs 1.0 New Course Offering - This course discusses Brazil’s technical regulations for medical devices, including RDC 16/2013 for Good Manufacturing Practices (GMPs) of Medical Devices and In Vitro Diagnostic Devices (IVDs), RDC 67/2009 for Technovigilance Requirements for Registration Holders, and RDC 23/2012 for Field Action Requirements. Topics in this course include: Background, Elements, and Applications. After completing this course, learners will be able to identify each of these regulations and recognize the practical actions to use in the normal course of business to ensure that the regulations are adhered to.
Major EHS42 HAZWOPER Awareness General Industry Environmental Health and Safety 4.0 MSDS (Material Safety Data Sheet) to SDS (Safety Data Sheet) updates. 
Major PHA46 Protection of Human Subjects in Clinical Trials Life Science Clinical: Pharmaceutical 4.0 Update to include ICH E6(R2).
Major PARTD05 Medicare Part D: PDP Enrollment Healthcare Medicare Part D 4.0 Addition of Special Enrollment Periods (SEPs), updates to retiree drug subsidies, incomplete enrollments, and premium payments. 
Major PHDV89 A Tour of Health Canada Life Science Clinical: Pharmaceutical, Clinical: Medical Device 3.0 Course rewritten to reflect current regulatory needs. After a brief introduction, the course will focus on the Health Products and Food Branch (HPFB) of Health Canada, which directly affects pharmaceutical manufacturers. Topics in this course include: Purpose, Organization, HPFB, TPD, BGTD, and HPFBI. After completing this course, learners will be able to identify the major branches of Health Canada, the HPFB, and its directorates. Learners will also be able to identify the unique roles and responsibilities of the three HPFB directorates that most directly affect the pharmaceutical industry.
Major PHDV94 Japanese Medical Device and Pharmaceutical Regulations    Life Science Global Regulatory 2.0 Regulation updates to the Japanese medical device regulations required full rewrite of content. This course explores the scope and applicability of Japan’s new Act on Medical Devices (PMD Act). Topics in this course include: History, Agencies, Approval Process, PMD vs ISO 13485, and Labeling. After completing this course, learners will be able to recognize the general structure of PMD and its requirements for the manufacture and distribution of medical devices to the Japanese market.
New PHDV104 CFDA Order No. 25 -- Good Clinical Practices for Medical Devices Life Science Global Regulatory 1.0 New Course Offering - China Food and Drug Administration (CFDA) Order No. 25 — Good Clinical Practice for Medical Devices was enacted to strengthen the administration, supervision, and management of clinical trials medical devices. Topics in this course include: General Provisions, Preparation Before Clinical Trials, Guarantee of Rights and Interests of Subjects, Clinical Trial Protocol, Responsibilities of Ethics Committee, Responsibilities of Sponsors, Responsibilities of Clinical Trial Institutions and Investigators, Recording and Reporting, and Management of Investigational Medical Devices.

After completing this course, learners will be able to identify participating regulatory agencies. Learners will also be able to identify the rights of clinical trial subjects and the responsibilities of investigators, sponsors, the administrative department, and the ethics committee. Lastly, learners will be able to recognize the documentation and reporting requirements for clinical trials.
Major PPACA03 Introduction to Medicaid Healthcare PPACA 4.0 Information added on eligibility and benefits, added chapter on enrollment, removed chapters on prescription drugs, quality improvement and dual eligibles. Also streamlined and clarified information throughout course. 

 April 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New DEV60 An Introduction to ISO 9001:2015 - The Quality Management System Requirements Life Science Medical Device GMPs 1.0 New Course Offering - This course serves as an introduction 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 which meet customer satisfaction and applicable statutory and regulatory requirements. Topics in this course include: Scope, Principles, Certification, Auditing, and Resources. After completing this course, learners will be able to identify the quality management principles and be able to recognize considerations for selecting a certification body as well as appropriate preparations for certification audits.
New Aseptic08 Cleanroom Cleaning, Sanitization, and Disinfection Life Science Program Only: Aseptic Processing: Advanced Series 1.0 New title in the Aseptic Processing: Advanced Series Program. In order to achieve safe and effective products, manufacturers of sterile product must employ various contamination control methods, such as cleaning, sanitization, and disinfection in the cleanroom. Topics in this course include: Contamination, Cleaning, Sanitization and Disinfection, and Additional Considerations. After completing this course, learners will be able to recognize why cleaning and sanitization are critical to contamination control in the cleanroom. Learners will also be able to identify the differences between cleaning, sanitizing, and disinfecting. Lastly, learners will be able to recognize proper basic cleaning procedures as well as critical parameters for effective sanitization.
Minor FDA33 Deconstruction and Reconditioning Life Science FDA Inspections and Enforcement 1.4 Course update to EduFlex, grammatical changes. 
Minor HIPAA09 HIPAA Privacy: Role-Based Training IV Healthcare HIPAA 1.2 Course update to EduFlex, grammatical changes. 
Major MA40 Medicare Advantage: Provider Networks Healthcare Medicare Advantage 3.0 Removed of Application Process - submission of HSD tables changed, added chapter on Network Adequacy with current HSD table guidance, and deleted chapters on monitoring tools and provider network maintenance. 
Major MSALES05 Medicare Plan: Broker and Agent Training -  Marketing Healthcare Medicare Broker/Agent Training 5.0 Regulatory updates from Medicare Managed Care Manual, Chapter 3, Medicare Marketing. 
Major MSALES06 Medicare Plan: Broker and Agent Training - Exam Healthcare Medicare Broker/Agent Training 3.0 Exam rewritten due to regulatory changes in MSALES01-MSALES05. 
Major PHDV86 Testing for Bacterial Endotoxins Life Science Medical Device GMPs, Pharmaceutical GMPs 2.0 Inclusion of guidance material: Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, June 2012; Endotoxin Testing Recommendations of Single-Use Intraocular Ophthalmic Devices, August 17, 2015; Recommendations for Microbial Vectors used for Gene Therapy, September 2016.

 March 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New DP01 General Data Protection Regulation General Industry Premium Content 1.0 This course covers the European Union’s (EU’s) General Data Protection Regulation (GDPR), a harmonized data privacy law across Europe. Topics include: General Provisions and Principles, Rights of the Data Subject, Data Processors and Controllers, and Other Considerations.  Learners will also be able to recognize the general provisions of the GDPR, and identify data subject rights under the Regulation, and identify controller and processor obligations related to data privacy and security.
Minor EHS11 Building Customer Loyalty General Industry HR Compliance & Risk Management 1.2 Course update to EduFlex, grammatical changes. 
Major EHS12 Flammable Liquids General Industry Environmental Health & Safety 5.0 Removal of combustible liquid references per OSHA regulatory updates, inclusion of OSHA's 4 categories of flammable liquids. 
Major ETHICS09 Doing the Right Thing: Anti-Bribery General Industry Ethics & Corporate Responsibility 3.0 Regulation changes in reference to Vietnam, South Korea, Indonesia, Thailand, and the Philippines. 
Minor FDA27 Interviewing Techniques Life Science FDA Inspections & Enforcement, Pharmaceutical GMPs 1.3 Course update to EduFlex, grammatical changes. 
Major MSALES01 Medicare Plan: Broker and Agent Training — Broker/Agent Requirements Healthcare Medicare Broker/Agent Training 3.0 Regulatory updates including Medicare Managed Care Manual Chapter 21, Prescription Drug Benefit Manual Chapter 9, and Medicare Managed Care Manual Medicare Marketing Guidelines Chapter 3. 
Major MSALES03 Medicare Advantage and Part D Plan: Broker and Agent Training – MA-PD, PDP, and Cost Plan Enrollment and Disenrollment Healthcare Medicare Broker/Agent Training 4.0 Nomenclature update of "Medicare Plans" to "Medicare Advantage and Part D plans", update to verification requirements, election period, and clarity for POA requirements. Inclusion of Medicare Beneficiary Identifier (MDI). 
Major MSALES04 Medicare Plan: Broker and Agent Training — Beneficiary Protections Healthcare Medicare Broker/Agent Training 6.0 Part C and Part D appeals process updated to reflect 2018 Managed Care appeals process.
Major PHA36 Good Clinical Practices (GCPs) for New Product Investigations Life Science Clinical: Medical Device, Clinical: Pharmaceutical 4.0 Update includes revisions of ICH E6(R2). 
Major PHDV68 Biotechnology: An Overview of Compliance Considerations  Life Science Pharmaceutical GMPs 3.0 Rewrite to align to current GMP manufacturing processes. 
Major PHDV78 Application of cGMPs to Analytical Laboratories  Life Science Medical Device GMPs, Pharmaceutical GMPs 4.0 Inclusion of Aseptic Technique and data requirements. 
Major QSR01 QS Regulation 1: Overview and General Provisions  Life Science FDA Inspections & Enforcement, Medical Device GMPs 3.0 Update to reflect revised sections of 21 CFR Part 821 & 820, additional case studies and content related to the FD&C Act/Preamble of the QS Regulations. 
Minor QSR04 QS Regulation 4: Document and Purchasing Controls Life Science FDA Inspections & Enforcement, Medical Device GMPs 1.4 Case study updates, charts related to FDA 483s, and clarifications related to 21 CFR Part 821. 
Major QSR06 QS Regulation 6: Acceptance Activities; Nonconforming Product Life Science FDA Inspections & Enforcement, Medical Device GMPs 2.0 Regulation and definition updates per 21 CFR Part 812 & 820, and the FD&C Act. Additional case studies added. 
Minor QSR10 QS Regulation 10: Servicing; Statistical Techniques Life Science FDA Inspections & Enforcement, Medical Device GMPs 1.3 Updates to case studied, definition and test question refinements. 
Minor QSR11 QS Regulation 11: Application and Inspection of QS Regulation Requirements Life Science FDA Inspections & Enforcement, Medical Device GMPs 1.4 Regulation and definition updates per 21 CFR Part 820, addition of charts outline FDA Inspectional Data Findings. 

 February 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New ASEPTIC05 RABS for Aseptic Processing Life Science Program Only - Aseptic Processing: Advanced Series 1.0 New title in the Aseptic Processing: Advanced Series Program. Users will be able to identify the key benefits of RABS for aseptic processing,
recognize the major process steps for aseptic processing using RABS technology and
recognize the importance of proper glove use and aseptic technique in a RABS environment. Users will also be able to identify methods for material transfer with a RABS unit and recognize the environmental monitoring techniques applicable to RABS.
Major ETHICS15 Privacy and Data Protection General Industry Ethics & Corporate Responsibility 3.0 Removal of Safe Harbor, inclusion of EU Privacy Shield provisions and options for compliance. 
Minor FDA26 FDA Establishment Inspection Report Writing Life Science FDA Inspections and Enforcement 6.1 Course update to EduFlex, grammatical updates. 
Minor PARTD02 Medicare Part D: Grievances, Coverage Determinations and Appeals Healthcare Medicare Part D 6.1 Added generic substitution to formulary management controls, tier exceptions to exception requests, requirements of an investigation of grievance issues and notice requirements, updatedrecord keeping requirements, AIC limits updated, and AOR representative language.
Minor PARTD05 Medicare Part D: PDP Enrollment Healthcare Medicare Part D 8.1 Original course split into two offerings, PARTD05 (Enrollment) and PARTD11 (Disenrollment). Content updates include Chapter 3, Section 40.4.1, Enrollment Form requirements, and Chapter 3, Section 10 and Appendix 3 on OEC application changes.
New PARTD11 Medicare Part D: PDP Disenrollment and Transaction Processing Healthcare Medicare Part D 1.0 Content split from PARTD05. Please couple training of PARTD05 with PARTD11. 
Major QSR05 QS Regulation 5: Identification and Traceability; Production and Process Controls Life Science FDA Inspections & Enforcement, Medical Device GMPs 2.0 Case Study updates, FDA 483s regulation updates per 21 CFR Part 820.

 January 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor ETHICS18 Preventing Sexual Harassment General Industry Ethics & Corporate Responsibility 1.1 Addition of workplace bullying.
Minor ETHICS19 Discrimination and Harassment Free Workplace General Industry Ethics & Corporate Responsibility 1.1 Addition of workplace bullying.
Minor FDA46 Courtroom Testimony Life Science FDA Inspections and Enforcement 1.3 Course format change to EduFlex, grammatical changes.
Minor HIPAA06 HIPAA Privacy: Role-Based Training I (Incidental PHI Contact) Healthcare HIPAA 1.1 Course format upgrade to EduFlex.
Minor HIPAA07 HIPAA Privacy: Role-based Training II (Internal Uses of PHI) Healthcare HIPAA 1.1 Course format upgrade to EduFlex.
Minor HIPAA08 HIPAA Privacy: Role-Based Training III (Uses and Disclosures of PHI) Healthcare HIPAA 1.1 Course format upgrade to EduFlex.
Minor LAV08 Sexual Harassment Awareness for Employees General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management 2.1 Addition of workplace bullying.
Minor LAV09 Sexual Harassment Awareness for Managers General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management 3.1 Addition of workplace bullying.
Minor LAV21 Harassment in the Workplace General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management 1.4 Addition of workplace bullying.
Major MSALES02 Medicare Plan: Broker and Agent Training — Medicare Basics  Healthcare Medicare Broker/Agent Training 7.0 Course format change to EduFlex, adding info on CFR, Title 45 on Lawfully Present Regulation, changes in benefit summary requirements, and call center requirements.

 December 2017 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor EHS17 DOT Employee Drug and Alcohol Awareness  General Industry Environmental Health and Safety 1.2 Case studies and statistics, drug listings. 
Minor EHS46 Hoists and Rigging General Industry Environmental Health and Safety 2.1 Content restructure, grammatical changes. 
Minor EHS55 Ladder Safety   General Industry Environmental Health and Safety 2.1 Content restructure, grammatical changes.
Major GCP27 Administrative Roles of the Clinical Research Coordinator Life Science Clinical: Medical Device, Clinical: Pharmaceutical 2.0 Update to include 45 CFR Part 56 Subpart A, ICH E6 (R2).
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. 
Minor PHA77 European Union Good Distribution Practices for Medicinal Products   Life Science Global Regulatory, Pharmaceutical GMPs 1.1 Updates include final draft of Drug Chain Securities Act, reissue of EU Guidelines on GDP for Medicinal Products. 
Major QSR02 QS Regulation 2: Quality System Requirement Life Science FDA Inspections and Enforcement, Medical Device GMPs 2.0 Inclusion of FD&C Act Chapter 5: Drugs and Devices.
Minor QSR03 QS Regulation 3: Design Controls  Life Science FDA Inspections and Enforcement, Medical Device GMPs 1.4 Case Study updates, FDA 483s regulation updates per 21 CFR Part 820.
Minor QSR09 QS Regulation 9: Records  Life Science FDA Inspections and Enforcement, Medical Device GMPs 2.1 Grammatical changes. update case studies.

 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.