Course Update Portal

This page lists UL PURE Learning courses that are “New”, or have received a “Major” or “Minor” update as well as “Retired” courses. “Major” updates include regulation changes, and retraining should be initiated. The course update explanations below can assist you in deciding whether or not to assign retraining as well as identifying replacement courses, if available, for retired courses.

This portal provides a rolling multi-month history, and categorizes our courses into Life Science (GMP, Clinical, Compliance, Sales, etc.), General Industry (EHS, Safety and Manufacturing, Construction, Transportation, Ethics, Corporate Compliance, etc.), and Healthcare (Medicare Advantage, Part D, 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 OnDemand  online knowledge base for available courses and educational programs.


November 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Major GCP05 HIPAA — The Impact on Clinical Research Pharmaceutical & Medical Device Clinical: Medical Device & Clinical: Pharmaceutical 4.0 Updated past tense of GDPR terminology to reflect current terminology. Questions updated to better match content.
Major GHC06 Introduction to Specialty Pharmacy Management Healthcare: Specialty Pharmacy Healthcare: General 3.0 Updated to include updated definitions, updated Classification Criteria, updated references and tables, and updated all questions to match. Added Specialty Tier information.
Major GCP21 Clinical Trial Audits and Consequences of Noncompliance Pharmaceutical & Medical Device Clinical: Medical Device & Clinical: Pharmaceutical 4.0 Updates related to FDA Guidance: Clinical Investigator Regulatory Sanctions – Information Sheet, and BIMO Compliance Program Guidance Manual 7348.811. Clarified references to Form FDA 483. Added reference to Debarment List. Additional formatting throughout course.
Minor PHA38 Introduction to cGMPs Pharmaceutical Medical Device GMPs & Pharmaceutical GMPs 3.2 Course underwent a Graphic refresh. No content changes were made.
Minor PHDV61 GxPs Medical Device
Pharmaceutical
Clinical: Medical Device & Clinical: Pharmaceutical GMPs 1.5 Updated labeling of GXP/Life cycle development graphics. Minor wording updates for clarification purposes.
Minor ETHICS14 Global Anti-Bribery All Industries Ethics & Corporate Responsibility 1.2 Updated to reflect recent legislation in various countries. Add information relating to the most recent Corruptions Perceptions index information..
Minor PHDV71 Principles of Aseptic Processing Medical Device & Pharmaceutical Pharmaceutical GMPs 6.1 Added content based on current cGMPs and EU Annex 1 revisions
Minor PHA73 Tools and Techniques for Effective CAPA Systems Pharmaceutical Pharmaceutical GMPs 1.2 Removed older ASQ references, updated definitions, added information pertaining to non-conformance to better match CAPA data sources. And CAPA tools. References updated.
Minor DEV60 An Introduction to ISO 9001:2015 — The Quality Management System Requirements Medical Device Medical Device GMPs 1.1 Updated information to reflect current year 2019. Content edited for clarity. Links and references verified.
Minor ICHreg06 Quality Systems Approach Pharmaceutical Global Regulatory 3.1 Updated references to match current FDA guidance and links updated to match current FDA web addresses

October 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New DP03 California Consumer Protection Act 0 0 1.0 This course describes the general requirements of the California Consumer Privacy Act (CCPA) of 2018.
New MDSAP07 Chapter 7 Process – Purchasing 0 0 1.0 This Course verifies that the manufacturer’s processes ensure that products are in conformance with specified purchase requirements.
New MDSAP_Canada Health Canada – MDSAP Country-Specific Tasks 0 0 1.0 This course describes the Health Canada country-specific tasks for the Medical Device Single Audit Program (MDSAP).
Major EHS23 Electrical Safety n/a n/a 3.0 Updated Equipment section to include AFCIs and TRRs.
Minor MAPD03 MAPD/PDP: Communications and Marketing Health Plans Health Plans 12.1 Course has been updated to include changes to the MCMG on 8/6/19.
Major GHC04 Fraud and Abuse Awareness Health Plans Health Plans 5.0 Updated to clarify the FDRs are not required to complete FWA training.
Major FDA57 Part 11: Electronic Records and Signatures – Enforcement Policy “Pharmaceutical
Medical Device”
“Pharmaceutical
Medical Device”
4.0 Updated to recognize that the guidance document was issued in 2003. Added examples of FDA Warning Letters.
Major GCP11 Overview of the Clinical Research Process “Pharmaceutical
Medical Device”
“Pharmaceutical
Medical Device”
4.0 Course updated to include clarifications to Post Marketing – Phase 4, revised text of phase 3 clinical trials.
Major PARTD01 Medicare Part D: Administration and Management Health Plans Health Plans 5.0 Course updated to include most recent Final Rule update – CMS-4182-F.
Minor ETHICS19 Discrimination and Harassment Free Workplace All Industries All Industries 1.2 Coruse updated to include references to sexual orentiation, stereotyping, available remedies, and investigation.
Minor PARTD05 Medicare Part D: PDP Enrollment Health Plans Health Plans 12.1 Updated verbage, revised SEPs for clarity, revised questions.

September 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New ETHICS25 Work Secure: Security Measures for Employees All Industries Ethics and Corporate Responsibility 1.0 This course offers all employees ways to ensure they are helping to protect against theft, sabotage, or harm to themselves, their fellow employees, and their company.
Major GCP15 Drug Safety & Adverse Event Reporting Pharmaceutical Clinical: Pharmaceutical 6.0 This course was updated to cover regulatory changes to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 and Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Major MDSM04 MedTech Europe Code of Ethical Business Practice Medical Device Medical Device – Sales & Marketing 4.0 This course was updated to reflect updates to the MedTech Code encompassing consolidation of th EucoMed and EDMA codes and guidlines refarding implementation periods.
Major PHDV93 Combination Products – cGMP Medical Device Pharmaceutical Medical Device GMPs
Pharmaceutical GMPs
2.0 This course was updated to include new versions of FDA Guidance documents and new Guidance documents relating to Combination Procucts.
Minor LAV24 Sexual Harassment Awareness for California Employees All California Industries Ethics & Corporate Responsibility
HR Compliance & Risk Management
1.1 Content added to further satisfy all CA requirements. Narration delay removed.
Minor EHS41 Uniform Hazardous Waste Manifest Completion EHS EHS for Life Science 2.2 Course references updated.
Minor EHS51 Environmental Management Systems EHS EHS for Life Science 2.1 Course references updated.
Revision LAV22 Harassment Avoidance Training for California All California Industries Ethics & Corporate Responsibility
HR Compliance & Risk Management
Course adjusted to correct delays in narration and the flow of the course.
Retired CWIRE_ACE_01 ComplianceWire Administrator Certification Exam — Basic N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired CWIRE_ACE_02 ComplianceWire Administrator Certification Exam – Advanced N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired CWIRE_Adv_ACE ComplianceWire Advanced Administrator Certification N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired CWIRE_Base_ACE ComplianceWire Basic Administrator Certification N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired EHS36 Glutaraldehyde N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired EHS81 Quality Management Refresher N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired FDA47 Photography for FDA Enforcement N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired LAVP01 Sexual Harassment Policy N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired MDSM06 Ethical Third Party Sales and Marketing Intermediary (“SMI”) Relationships N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired MSales06 Broker and Agent Training Exam N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired PHDV90 A Tour of Health Europe N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired PHDV97 Introduction to CFDA and CFDA Registration N/A N/A N/A This course is being retired because of FLASH incompatibilities. No replacement has be designated due to low usage.
Retired SECURE06 WorkSecure: Security Measures for Employees N/A N/A N/A This course is being retired and replaced with Ethics25. Contact Client Services for information regarding replacement or equivalency settings.

August 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New MDSAP_Australia Australia Therapeutic Goods Administration (TGA) MDSAP Specific Medical Device Medical Device GMPs, Global Regulatory 1.0 This course covers Australia’s Therapeutic Goods Administration (TGA) requirements specific to all seven chapters in the Medical Device Single Audit Program (MDSAP).
New MDSAP_Brazil Brazil Therapeutic Goods Administration (TGA) MDSAP Specific Medical Device Medical Device GMPs, Global Regulatory 1.0 This course covers Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) requirements specific to all seven chapters in the Medical Device Single Audit Program (MDSAP).
New MDSAP_Japan Japan Therapeutic Goods Administration (TGA) MDSAP Specific Medical Device Medical Device GMPs, Global Regulatory 1.0 This course covers Japan’s Ministry of Health, Labour and Welfare (MHLW) requirements specific to all seven chapters in the Medical Device Single Audit Program (MDSAP).
New MDSAP05 MDSAP Chapter 5: Process: Design and Development. Medical Device Medical Device GMPs, Global Regulatory 1.0 This course covers Chapter 5 of the Medical Device Single Audit Program (MDSAP) — Process: Design and Development.
New MDSAP06_01 MDSAP Chapter 6: Process – Production and Service Controls – Part 1 Health Plans PPACA 1.0 This course covers the first 15 tasks of Chapter 6 of the Medical Device Single Audit Program (MDSAP) — Production and Service Controls.
Major EHS50 Infection Prevention and Control EHS EHS for Life Science – Basics 2.0 References have been added to the course.
Major FDA42 Import Operations 2: The Process “Pharmaceutical Medical Device Food and Beverage” FDA Inspections and Enforcement 3.0 Content updated for clarity and additional resource references have been added.
Minor EHS25 EPA Inspections EHS EHS Course visuals have been refreshed. Content edited for formatting, spelling, and grammar.
Minor ETHICS13 Detecting and Preventing Fraud All Industries Ethics & Corporate Responsibility 1.1 Course Visuals have been refreshed. Content edited for formatting, spelling, and grammar.
Minor ETHICS16 Foreign Corrupt Practices Act (FCPA) All Industries Ethics & Corporate Responsibility Course visuals have been refreshed. Content edited for formatting, spelling, and grammar.
Minor FDA31 Part 11: Electronic Records; Electronic Signatures Pharmaceutical, Medical Device FDA Inspections and Enforcement, Pharmaceutical GMPs 4.2 Updated the section on bio-metric signatures to include other forms of bio-metric recognition beyond fingerprints such as facial recognition and retinal scanning technologies.
Minor GCP23 Investigational Product Development Pharmaceutical, Medical Device Clinical: Pharmaceutical 1.5 Updated information relating to Medical Device trials and classifications, updated the MDUFMA reference. Content edited for formatting, spelling, and grammar.
Minor GCP25 Laboratory Specimens for Clinical Research Pharmaceutical, Medical Device Clinical: Medical Device, Clinical: Pharmaceutical 1.4 Updated lab requirements related to 21 CFR -211. Added details on CLIA for IVDs and added references to FDA Guidance for Industry: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Applications for Manufacturers of In Vitro Diagnostic Devices.
Minor PARTD08 Medicare Part D: Medication Therapy Management and Quality Improvement Program Health Plans Medicare Part D 9.1 Updated information on Over-utilization Monitoring specifics, Formulary Changes, and updated references. Content edited for formatting, spelling, and grammar.

July 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New MDSAP06_01 MDSAP Chapter 6: Process – Production and Service Controls – Part 1 Health Plans PPACA 1.0 This course covers the first 15 tasks of Chapter 6 of the Medical Device Single Audit Program (MDSAP) — Production and Service Controls.
New MDSAP06_02 MDSAP Chapter 6: Process – Production and Service Controls – Part 2 Health Plans PPACA 1.0 This course covers Tasks 16–29 of Chapter 6 of the Medical Device Single Audit Program (MDSAP) — Production and Service Controls.
Major PHSM05 Promotion of Pharmaceutical Products – Field Facing Pharmaceutical Pharmaceutical – Sales & Marketing 3.0 Update of course content.
Major EHS75 Process Safety Management: Operating Procedures EHS Process Safety Management 2.0 Update of course content.
Major FDA43 Import Operations 3: Other Activities Pharmaceutical, Medical Device, Food and Beverage FDA Inspections and Enforcement 8.0 Changed OASIS system name and description to PREDICT. Edited script for clarity.
Major GCP04 GCP/ICH Obligations of Sponsors and Monitors Pharmaceutical Clinical: Medical Device, Clinical: Pharmaceutical 3.0 Update of course content.
Major MA40 Medicare Advantage: Provider Networks Health Plans Medicare Advantage 8.0 Update of course content.
Major MA41 MA Quality Management and Utilization Management Health Plans Medicare Advantage 8.0 Update to include all needed changes in the QI/CCIP requirements effective January 1, 2019.
Major PARTD01 Medicare Part D: Administration and Management Health Plans Medicare Part D 4.0 Update of course content.
Minor EHS79 Process Safety Management: Process Safety Information EHS Environmental Health and Safety 1.2 Update of course content.
Minor GCP16 European Union Clinical Trial Regulation Pharmaceutical, Medical Device Clinical: Medical Device, Clinical: Pharmaceutical 4.0 Update of course content.
Minor LAV23 Sexual Harassment Awareness for New York Employees and Supervisors All Industries HR Compliance & Risk Management
Ethics & Corporate Responsibility
1.1 Update of course content.

June 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Major BIMO03 Introduction to Medicaid Medical Device, Pharmaceutical FDA BIMO Course Series 3.0 Update to reflect current changes to regulations (2018), removed History section to reduce course time, minor gramatical edits.
Major DATA02 Audit Computer System Validation to Ensure Data Integrity Medical Device, Pharmaceutical FDA BIMO Course Series 2.0 Update to include ALCOA+, Providing definition and explanation of SDLC, and updated references.
Major MA29 Medicare Advantage: Overview of the Medicare Program Health Plans Medicare Advantage 5.0 Update of training material and course content.
Major PARTD05 Medicare Part D: PDP Enrollment Health Plans Medicare Part D 12.0 Revised course objectives, reorganized section and added new SEPs in Chapter 3, reorganized information in Chapter 4, made minor revisions to application dates on page 26, and revised conclusion.
Major PARTD10 Medicare Part D: Coordination of Benefits and True Out-of-Pocket Facilitation Health Plans Medicare Part D 8.0 Incorporate new 2019 information from section 50.2 of Part D Chapter 14 into Chapter 3, updated limits in Chapter 4 to reflect 2019 amounts.
Major PHA77 EU Good Distributation Practices Pharmaceutical Pharmaceutical GMPs & Global Regulatory 3.0 Updated to current changes to regulationd (2018), removed History section to reduce course time, minor gramatical edits.
Major PPACA03 Introduction to Medicaid Health Plans PPACA 5.0 Update of training material and course content.
Minor PHA74 Principles of Good Documentation Pharmaceutical GMPs & Global Regulatory Pharmaceutical GMPs & Global Regulatory 1.2 Update and clarification of the QC and QA roles to align with current industry practices.
Revision PHA78 European Union GMP Requirements Pharmaceutical GMPs & Global Regulatory Pharmaceutical GMPs & Global Regulatory 1.0 Update of minor typographical and gramatical errors.

May 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor LAV08 Sexual Harassment Awareness for Employees General Industry Ethics & Corporate Responsibility
HR Compliance & Risk Management
2.2 Version Verification, Minor Technical Corrections
Minor LAV09 Sexual Harassment Awareness for Managers General Industry Environmental Health & Safety 3.2 Included Course References,
Clarified Responsibility of Investigating Complaints
New EHS62 Managing Conflict General Industry Ethics & Corporate Responsibility
HR Compliance & Risk Management
1.5 Conversion to EduFlex
Minor LAV21

Sexual Harassment Awareness for Employees

General Industry HR Compliance & Risk Management
Ethics & Corporate Responsibility
1.5 Version Verification, Minor Technical Corrections

April 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor BIMO06 BIMO: In Vivo Bioequivalence Program Part I Life Science FDA BIMO Course Series 2.1 Conversion to EduFlex
Major EHS69 Process Gauge Radiation General Industry Environmental Health & Safety 3.0 Conversion to EduFlex, MSDS to SDS.
Major EHS71 Process Safety Management: Contractors General Industry Environmental Health & Safety 2.0 Conversion to EduFlex, MSDS to SDS.
Major EHS72 Process Safety Management: Incident Investigation General Industry Environmental Health & Safety 2.0 Conversion to EduFlex, MSDS to SDS.
Major MA38 Medicare Advantage: Claims Processing Healthcare Medicare Advantage 7.0 Changes reflect 2019 CMS updates as set forth by Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance (Released February 2019) guidelines.
Minor DEV56 Good Documentation Practices for Medical Device Manufacturers Life Science Medical Device GMPs, Global Regulatory 1.2 Visual Refresh.
Minor DEV59 Computerized Systems in the Medical Device Industry Life Science FDA Inspections & Enforcement, Medical Device GMPs 3.1 Visual Refresh.

March 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
New ETHICS26 Doing Business with the US Government General Industry Ethics & Corporate Responsibility 1.0 Replaces RH011
New ETHICS27 US Trade Controls General Industry Ethics & Corporate Responsibility 1.0 Replaces RH0025
New ETHICS28 Trade Secrets General Industry Ethics & Corporate Responsibility 1.0 Replaces RH0034
Major MA41 Medicare Advantage: Quality Management and Utilization Management Healthcare Medicare Advantage 7.0 Changes to Final Rule, Quality Improvement Projects (QIPs) removed.
Major BIMO01 Overview of FDA’s Bioresearch Monitoring Program Life Science Clinical: Medical Device, Clinical: Pharmaceutical, FDA BIMO Course Series 4.0 Conversion to EduFlex, regulatory updates.
Major MAPD03

MAPD/PDP: Communications and Marketing

Healthcare Medicare Advantage, Medicare PART D 12.0 Regulatory updates.
Major PHDV87

Environmental Control and Monitoring

Life Science Medical Device GMPs, Pharmaceutical GMPs 5.0 Regulatory Updates: Eudralex Vol. 4 EU Guidelines for GMP Medicinal Products for Human and Veterinary Use – Annex 1.
Major GCP17 The Role of the Clinical Research Associate Life Science Clinical: Medical Device, Clinical: Pharmaceutical 2.0 Update to include EU Clinical Trials Register (EU CTR).
Major BIMO05 BIMO: Sponsor/Monitor Responsibilities Life Science FDA BIMO Course Series 3.0 Regulatory update: 21 CFR 312, 21 CFR 812, and 21 CFR 511.
Major EHS115 DOT Hazardous Materials Training – Security Awareness General Industry Environmental Health and Safety 2.0
Update to reflect establishing/maintaining Security Plan – 49 CFR 172.800(b).
Major GCP18 The Role of the Clinical Research Coordinator Life Science Clinical: Medical Device, Clinical: Pharmaceutical 4.0 Update to include EU CTR.

February 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Major GCP01 GCP/ICH Obligations of Sponsors, Monitors, and Investigators Life Science Clinical: Medical Device, Clinical: Pharmaceutical  5.0 Regulatory changes due to ICH E6 (R2) revision published in March 2018.
Major MDR03 CE Certification for Medical Devices Life Science Medical Device GMPs, Global Regulatory 3.0 Regulatory update focused on the finalization of EU MDR 2017/745.

January 2019 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor BIMO07 BIMO: In Vivo Bioequivalnce Program Part II Life Science FDA BIMO Course Series 2.1 Conversion to EduFlex, grammatical changes.
Minor ETHICS14 Global Anti-Bribery All Industries Ethics & Corporate Responsibility 1.1 Incorporate concepts from RH0041-UK, updated Corruptions Perception Index, and regional regulation update.
Minor PHSM03 Contracting with and Providing Medical Education for Healthcare Professionals Life Science Pharmaceutical – Sales & Marketing 2.1 Grammatical and contextual updates.
Minor PRIVACY01 HIPAA and Privacy Guidelines for Medical Device Sales Representatives Life Science Medical Device – Sales & Marketing 2.2 Application of HIPAA to contemporary Medical Devices, focus content on medical device sales community.

 December 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor DATA04 Data Integrity for Quality Control Laboratories Life Science Data Integrity  1.1 Inclusion of ALCOA+.
New LAV24 Sexual Harassment Awareness for California Employees General Industry HR Compliance & Risk Management, Ethics & Corporate Responsibility 1.0 New title.
Major MA34 Medicare Advantage: Provider Compliance Healthcare Medicare Advantage 6.0 Regulatory updates.
Major MAPD01 Medicare Health Plan and PDP: Fraud, Waste, and Abuse Healthcare Medicare Advantage, Medicare Part D 5.0 Regulatory updates, beneficiary inducement limits and FWA monitoring and identification strategies updated.
Major PHDV78 Application of cGMPs to Analytical Laboratories Life Science Medical Device GMPs, Pharmaceutical GMPs 5.0 Regulatory updates.
New PHDV105 Australian Therapeutic Goods — Medical Device Regulations Overview Life Science Global Regulatory, Medical Device GMPs 1.0 New title.

November 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor BIMO04 BIMO: Clinical Investigator (CI) Responsibilities Life Science FDA BIMO Course Series 2.1 Conversion to EduFlex. Regulatory updates: 21 CFR Part 812 and 21 CFR Part 511.
Minor DATA01 Introduction to Data Integrity Life Science Data Integrity 2.1 Inclusion of ALCOA+.
Minor EHS95 Overcoming Negativity in the Workplace General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management 2.3 Conversion to EduFlex, grammatical changes.
Minor FDA01 Food and Drug Law: FDA Jurisdictions Life Science FDA Inspections & Enforcement 1.3 Conversion to EduFlex, grammatical changes.
Minor FDA02 Food and Drug Law: Prohibited Actions Life Science FDA Inspections & Enforcement 1.2 Conversion to EduFlex, grammatical changes.
Minor FDA03 Food and Drug Law: Judicial Actions Life Science FDA Inspections & Enforcement 1.2 Conversion to EduFlex, grammatical changes
Minor FDA04 Food and Drug Law: Criminal Acts Violations Life Science FDA Inspections & Enforcement 1.2 Conversion to EduFlex, grammatical changes
Minor FDA05 Food and Drug Law: Imports and Exports Life Science FDA Inspections & Enforcement 2.2 Conversion to EduFlex, grammatical changes
Major MAPD02 MAPD: Enrollment Healthcare Medicare Advantage 9.0 Regulatory Updates: Medicare Managed Care Manual, Chapter 2 — Medicare Advantage Enrollment and Disenrollment.
Major MAPD06

MAPD: Disenrollment

Healthcare Medicare Advantage 2.0 Regulatory Updates: Medicare Managed Care Manual, Chapter 2 — Medicare Advantage Enrollment and Disenrollment.
Major MDSM07

National Patient Safety Goals: HCIR Credentialing

Life Science Medical Device – Sales & Marketing 2.0 Regulatory updates.
Major OIG03

OIG Compliance Program Guidance for Medical Device Manufacturers – Field Force  

Life Science Medical Device – Sales & Marketing 3.0 Updated case studies, various regulatory changes and refreshed to current industry trends.
Major PHSM06

Interactions with Healthcare Professionals – In-House

Life Science Pharmaceutical – Sales & Marketing 2.0 Clarifications and enhancements to guidance regarding promotional materials and product communications; HCP training programs, other consulting engagements, and recent enforcement themes.

 October 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor EHS61 Making Meetings Work II: Leadership General Industry HR Compliance & Risk Management 1.2 Course update to EduFlex, grammatical changes.
Major MA38 Medicare Advantage: Claims Processing Healthcare Medicare Advantage 6.0 Combined content from Medicare Contractor chapter into Claims Processing chapter, added notice requirements for non-contracted providers.
Major MAPD03

MAPD/PDP: Communications and Marketing

Healthcare Medicare Advantage, Medicare Part D 11.0 Medicare Communications and Marketing Guidelines (MCMG) updates.
 Major MDSM03 Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (Mass.  Code) and Similar State-Level Requirements Life Science Medical Device -Sales & Marketing 3.0  Updated to reflect current regulations.
Major MSALES01 Medicare Plan: Broker and Agent Training — Broker/Agent Requirements Healthcare Medicare Broker/Agent Training 6.0 Medicare Managed Care Manual Chapter 3 — Medicare Communications and Marketing Guidelines (MCMG) regulation updates.
 Major MSALES02 Medicare Plan: Broker and Agent Training – Medicare Basics  Healthcare Medicare Broker/Agent Training  8.0 Updated 2019 Part D limits/amounts.
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 5.0 Added information about the Medicare Advantage Open Enrollment Period (OEP) and requirements for the short enrollment form and telephonic enrollment.
Major MSALES04 Medicare Plan: Broker and Agent Training – Beneficiary Healthcare Medicare Broker/Agent Training 7.0 Job aid additions for Part C and D Decisions and Appeals.
Major MSALES05 Medicare Plan: Broker and Agent Training — Marketing Communication and Compensation Healthcare Medicare Broker/Agent Training 6.0 Course updated to reflect changes to Medicare Marketing Guidelines (now called Medicare Communication and Marketing Guidelines (MCMG)).
 Major MSALES06 Medicare Plan: Broker and Agent Training — Exam  Healthcare Medicare Broker/Agent Training  4.0 Updated to reflect changes made in the MSALES series.
 Major PARTD05 Medicare Part D: PDP Enrollment  Healthcare Medicare Part D  11.0 Updated to reflect 2019 requirements.
Major PARTD11 Medicare Part D: PDP Disenrollment and Transaction Processing Healthcare Medicare Part D 2.0 Updated to reflect 2019 requirements.

 

 November 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor BIMO04 BIMO: Clinical Investigator (CI) Responsibilities Life Science FDA BIMO Course Series 2.1 Conversion to EduFlex. Regulatory updates: 21 CFR Part 812 and 21 CFR Part 511.
Minor DATA01 Introduction to Data Integrity Life Science Data Integrity 2.1 Inclusion of ALCOA+.
Minor EHS95 Overcoming Negativity in the Workplace General Industry Ethics & Corporate Responsibility, HR Compliance & Risk Management 2.3 Conversion to EduFlex, grammatical changes.
Minor FDA01 Food and Drug Law: FDA Jurisdictions Life Science FDA Inspections & Enforcement 1.3 Conversion to EduFlex, grammatical changes.
Minor FDA02 Food and Drug Law: Prohibited Actions Life Science FDA Inspections & Enforcement 1.2 Conversion to EduFlex, grammatical changes.
Minor FDA03 Food and Drug Law: Judicial Actions Life Science FDA Inspections & Enforcement 1.2 Conversion to EduFlex, grammatical changes
Minor FDA04 Food and Drug Law: Criminal Acts Violations Life Science FDA Inspections & Enforcement 1.2 Conversion to EduFlex, grammatical changes
Minor FDA05 Food and Drug Law: Imports and Exports Life Science FDA Inspections & Enforcement 2.2 Conversion to EduFlex, grammatical changes
Major MAPD02 MAPD: Enrollment Healthcare Medicare Advantage 9.0 Regulatory Updates: Medicare Managed Care Manual, Chapter 2 — Medicare Advantage Enrollment and Disenrollment.
Major MAPD06

MAPD: Disenrollment

Healthcare Medicare Advantage 2.0 Regulatory Updates: Medicare Managed Care Manual, Chapter 2 — Medicare Advantage Enrollment and Disenrollment.
Major MDSM07

National Patient Safety Goals: HCIR Credentialing

Life Science Medical Device – Sales & Marketing 2.0 Regulatory updates.
Major OIG03

OIG Compliance Program Guidance for Medical Device Manufacturers – Field Force  

Life Science Medical Device – Sales & Marketing 3.0 Updated case studies, various regulatory changes and refreshed to current industry trends.
Major PHSM06

Interactions with Healthcare Professionals – In-House

Life Science Pharmaceutical – Sales & Marketing 2.0 Clarifications and enhancements to guidance regarding promotional materials and product communications; HCP training programs, other consulting engagements, and recent enforcement themes.

 October 2018 Course Updates

Update Type Course Code Course Title Industry Course Library Version Update Details
Minor EHS61 Making Meetings Work II: Leadership General Industry HR Compliance & Risk Management 1.2 Course update to EduFlex, grammatical changes.
Major MA38 Medicare Advantage: Claims Processing Healthcare Medicare Advantage 6.0 Combined content from Medicare Contractor chapter into Claims Processing chapter, added notice requirements for non-contracted providers.
Major MAPD03

MAPD/PDP: Communications and Marketing

Healthcare Medicare Advantage, Medicare Part D 11.0 Medicare Communications and Marketing Guidelines (MCMG) updates.
 Major MDSM03 Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (Mass.  Code) and Similar State-Level Requirements Life Science Medical Device -Sales & Marketing 3.0  Updated to reflect current regulations.
Major MSALES01 Medicare Plan: Broker and Agent Training — Broker/Agent Requirements Healthcare Medicare Broker/Agent Training 6.0 Medicare Managed Care Manual Chapter 3 — Medicare Communications and Marketing Guidelines (MCMG) regulation updates.
 Major MSALES02 Medicare Plan: Broker and Agent Training – Medicare Basics  Healthcare Medicare Broker/Agent Training  8.0 Updated 2019 Part D limits/amounts.
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 5.0 Added information about the Medicare Advantage Open Enrollment Period (OEP) and requirements for the short enrollment form and telephonic enrollment.
Major MSALES04 Medicare Plan: Broker and Agent Training – Beneficiary Healthcare Medicare Broker/Agent Training 7.0 Job aid additions for Part C and D Decisions and Appeals.
Major MSALES05 Medicare Plan: Broker and Agent Training — Marketing Communication and Compensation Healthcare Medicare Broker/Agent Training 6.0 Course updated to reflect changes to Medicare Marketing Guidelines (now called Medicare Communication and Marketing Guidelines (MCMG)).
 Major MSALES06 Medicare Plan: Broker and Agent Training — Exam  Healthcare Medicare Broker/Agent Training  4.0 Updated to reflect changes made in the MSALES series.
 Major PARTD05 Medicare Part D: PDP Enrollment  Healthcare Medicare Part D  11.0 Updated to reflect 2019 requirements.
Major PARTD11 Medicare Part D: PDP Disenrollment and Transaction Processing Healthcare Medicare Part D 2.0 Updated to reflect 2019 requirements.

 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 1.2 Course update to EduFlex, grammatical changes.
Minor EHS49 Improving Productivity General Industry HR Compliance & Risk Management 1.2 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.
Minor LAV14 Antitrust Law and Competitor Relationships General Industry HR Compliance & Risk Management 1.3 Clayton Act annual limits updated.
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.