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Table of Contents
- Fundamentals Series
- Refresher Series
- Quality Systems
- Quality Management Systems (QMS) | Deviations
- Quality Management Systems (QMS) | CAPA
- Quality Management Systems (QMS) | Change Control
- Quality Risk Management (QRM)
- Inspections & Audits
- Supplier Qualification & Distribution
- Technical Writing
- Data Integrity & Good Documentation Practices (GDP)
- Quality Culture Drivers
- Good Manufacturing Practices (GMP)
- Combination Products
- GMP Operations
- Cell & Gene Therapy
- Cleanroom Operations
- Equipment
- Facilities
- Contamination Control
- Quality Control
- Isolation Technology
- Good Clinical Practices (GCP)
- Good Laboratory Practices (GLP)
- Good Pharmacovigilance Practices (GVP)
- Medical Device Topics
- Validation Topics
- Process & Cleaning Validation
- Commissioning, Qualification & Validation (CQV)
- Medical Device Validation
- Computer System Validation (CSV)
- Other Topics
- Corporate Compliance & HR
- Sexual Harassment & Prevention Training Series
- Environmental Health & Safety (EHS)
- Microlearning Videos
Fundamentals Series
Refresher Series
Quality Systems
Quality Management Systems (QMS) | Deviations
| Course Code | Title | Duration |
|---|---|---|
| ELM-227 | The Fundamentals of Deviations | 20 mins |
| ELM-265 | The Fundamentals of GCP Deviations | 15 mins |
| ELM-743 | The Fundamentals of Quality Management Systems – Pharma | 15 mins |
| ELM-994 | Quality Management System Refresher 2026 | 10 mins |
| ELM-196 | Deviation – Initiator | 15 mins |
| ELM-197 | Deviation – Investigator | 20 mins |
| ELM-404 | Root Cause Analysis | 30 mins |
| MLV-020 | What are Deviations? | 1 min |
| MLV-036 | The Power of Embracing Deviations in the Life Science Industry | 1 min |
| MLV-065 | Impact of Deviations on Product Quality | 3 mins |
| MLV-066 | Deviations and Process Improvements | 2 mins |
| MLV-067 | Importance of Deviation Investigations | 2 mins |
| MLV-068 | Importance of Timely Closures of Deviations | 2 mins |
| MLV-069 | Criticality of Openness in Deviation Investigations | 2 mins |
| MLV-085 | Deviations for Consumer Healthcare Products | 2 mins |
Quality Management Systems (QMS) | CAPA
| Course Code | Title | Duration |
|---|---|---|
| ELM-226 | The Fundamentals of Corrective and Preventive Actions (CAPA) | 20 mins |
| ELM-266 | The Fundamentals of GCP Corrective and Preventive Actions | 15 mins |
| ELM-117 | CAPA and Effectiveness Checks | 20 mins |
| MLV-023 | What are CAPAs? | 2 mins |
| MLV-070 | CAPAs and Continuous Improvement | 2 mins |
| MLV-071 | Why Checking Effectiveness Leads to Successful CAPAs | 2 mins |
| MLV-072 | The Importance of Associating CAPA Actions to Root Causes | 2 mins |
| MLV-073 | Working as a Team When Planning a CAPA | 2 mins |
| MLV-074 | Addressing Human Error Through CAPAs | 2 mins |
| MLV-090 | The Importance of Associating CAPA Actions to Root Causes – Consumer Healthcare Products | 2 mins |
Quality Management Systems (QMS) | Change Control
Quality Risk Management (QRM)
| Course Code | Title | Duration |
|---|---|---|
| ELM-232a | The Fundamentals of Quality Risk Management (QRM) | 20 mins |
| ELM-237 | ICH Q9 – Quality Risk Management | 25 mins |
| ELM-238 | ICH Q9 – Risk Management Methods and Tools | 20 mins |
| ELM-239 | QRM as Part of Integrated Quality Management | 20 mins |
| ELM-233 | ICH Q10 – Management Responsibilities | 20 mins |
| ELM-232b | Quality Risk Management (QRM): Global Regulations and Their Impact | 15 mins |
| ELM-259 | Customer Complaint Handling | 15 mins |
| ELM-960 | Recalls and Consent Decrees | 20 mins |
| ELM-961 | Regulatory Submissions | 15 mins |
| MLV-024 | What is Quality Risk Management (QRM)? | 3 mins |
| MLV-079 | Navigating QRM and Continuous Improvement | 3 mins |
| MLV-080 | Empowering Proactive Quality Through QRM | 3 mins |
| MLV-081 | Balancing Risk and Quality in Life Sciences | 3 mins |
| MLV-082 | Passive vs. Active Acceptance of Risk | 3 mins |
Inspections & Audits
Supplier Qualification & Distribution
| Course Code | Title | Duration |
|---|---|---|
| ELM-258 | Supplier Quality Management | 15 mins |
| ELM-107 | How to Perform Supplier Qualification | 60 mins |
| ELM-234 | The Fundamentals of Good Distribution Practice | 10 mins |
| ELM-812 | The Fundamentals of Good Distribution Practice for Consumer Healthcare | 10 mins |
| ELM-235 | Good Distribution Practices: Core Principles | 10 mins |
| ELM-240 | Good Distribution Practices: Operational Principles | 15 mins |
| ELM-985 | Principles of Quality Agreements | 20 mins |
Technical Writing
| Course Code | Title | Duration |
|---|---|---|
| ELM-126 | Writing Effective Standard Operating Procedures | 15 mins |
| ELM-127 | How to Write an Effective Equipment User Requirement Specification (URS) | 60 mins |
| ELM-505 | Technical Writing in a Regulated or Accredited Environment | 20 mins |
Data Integrity & Good Documentation Practices (GDP)
Data Integrity (DI)
| Course Code | Title | Duration |
|---|---|---|
| ELM-221 | The Fundamentals of Data Integrity | 10 mins |
| ELM-112 | The Fundamentals of Electronics Records and Signatures | 15 mins |
| ELM-148 | Data Integrity Awareness: An Introduction | 45 mins |
| ELM-151 | Data Integrity Awareness: Health Authorities | 45 mins |
| ELM-152 | Data Integrity Awareness: ALCOA+ | 15 mins |
| ELM-153 | Data Integrity Awareness: Good Documentation Practices | 40 mins |
| ELM-154 | CSA and Data Integrity: Assuring ALCOA+ | 20 mins |
| ELM-102 | Laboratory Data Integrity | 15 mins |
| ELM-963 | Data Integrity 2025 Annual Refresher | 10 mins |
| ELM-951 | Data Integrity 2024 Refresher Course | 10 mins |
| ELM-989 | Data Integrity Refresher 2026 | 10 mins |
| MLV-005 | Core Requirements of Good Documentation Practices | 3 mins |
| MLV-033 | Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video] | 1 min |
| MLV-044 | The Collective Responsibility of Data Integrity in the Life Science Industry | 1 min |
Good Documentation Practices (GDP)
Quality Culture Drivers
Good Manufacturing Practices (GMP)
GMP
21 CFR Part 211
| Course Code | Title | Duration |
|---|---|---|
| ELM-211 | 21 CFR Part 211 Subpart B: Organization and Personnel | 45 mins |
| ELM-205 | 21 CFR Part 211 Subpart C – Building and Facilities | 45 mins |
| ELM-212 | 21 CFR Part 211 Subpart D – Equipment | 45 mins |
| ELM-206 | 21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures | 45 mins |
| ELM-208 | 21 CFR Part 211 Subpart F: Production and Process Controls | 45 mins |
| ELM-209 | 21 CFR Part 211 Subpart G: Packaging and Labeling Control | 45 mins |
| ELM-207 | 21 CFR Part 211 Subpart H – Holding and Distribution | 30 mins |
| ELM-210 | 21 CFR Part 211 Subpart J – Records and Reports | 45 mins |
| ELM-213 | 21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products | 45 mins |
EudraLex - Volume 4 Annex 1
| Course Code | Title | Duration |
|---|---|---|
| ELM-745 | EudraLex – Volume 4 Annex 1: Pharmaceutical Quality Systems and Contamination Control Strategies | 15 mins |
| ELM-746 | EudraLex – Volume 4 Annex 1: Sterile Processing and Technologies | 20 mins |
| ELM-747 | EudraLex – Volume 4 Annex 1: Environmental Monitoring and Quality Control | 15 mins |
Combination Products
| Course Code | Title | Duration |
|---|---|---|
| ELM-145 | The Fundamentals of Combination Products | 15 mins |
| ELM-146 | Combination Products (Drugs, Devices and Biologics) – Part 2 | 45 mins |
| ELM-147 | Principles of Developing Device-Led Combination Products | 20 mins |
| MLV-035 | How the FDA Defines a Combination Product | 1 min |
GMP Operations
Cell & Gene Therapy
| Course Code | Title | Duration |
|---|---|---|
| ELM-725 | The Fundamentals of Cell and Gene Therapy | 15 mins |
| ELM-727 | Cell Therapy (CAR T) Processing | 15 mins |
| ELM-742 | Gene Therapy: Applications of Adeno-associated Viruses and Adenoviruses | 20 mins |
| ELM-728 | Gene Therapy: Adeno-Associated Virus and Lentivirus Processing | 15 mins |
Cleanroom Operations
| Course Code | Title | Duration |
|---|---|---|
| ELM-726 | The Fundamentals of Biotech Manufacturing | 10 mins |
| ELM-733 | Biotech Manufacturing: Aseptic Processing | 10 mins |
| ELM-739 | Winning Cleanroom Behaviors | 10 mins |
| MLV-027 | Requirements for All Staff in an Aseptic / GMP Environment | 1 min |
| MLV-028 | Clothing Requirements for Grades A/B, C and D | 1 min |
| MLV-030 | Why Personnel are Key in a GMP Manufacturing Environment | 1 min |
| MLV-046 | Access Control | 2 mins |
| MLV-050 | The Significance of Proper Gowning | 1 min |
| MLV-051 | The Importance of Proper Hygiene | 1 min |
| MLV-086 | Why Personnel Are Key In A Manufacturing Environment – Consumer Healthcare | 2 mins |
Equipment
| Course Code | Title | Duration |
|---|---|---|
| EQT-001 | Centrifuges | 5 mins |
| EQT-002 | Autoclaves | 10 mins |
| EQT-003 | Balances and Scales | 10 mins |
Facilities
| Course Code | Title | Duration |
|---|---|---|
| ELM-264 | Equipment Maintenance | 15 mins |
| ELM-737 | Plant and Clean Utilities for GMP Manufacturing | 15 mins |
Contamination Control
| Course Code | Title | Duration |
|---|---|---|
| ELM-222 | The Fundamentals of Contamination Control | 20 mins |
| ELM-701 | Types of Contamination in a GMP Environment | 15 mins |
| ELM-702 | Sources of Contamination in a GMP Environment | 10 mins |
| ELM-704 | Contamination Control Strategies in a GMP Environment | 15 mins |
| MLV-016 | What is Drug Contamination? | 2 mins |
| MLV-017 | What is Drug Cross Contamination? | 1 min |
| MLV-018 | The Importance of Contamination Control | 1 min |
| MLV-019 | Sources of Contamination in a GxP Environment | 3 mins |
| MLV-047 | Clean Work Surfaces | 1 min |
| MLV-048 | Cleaning vs. Disinfecting | 1 min |
| MLV-084 | The Importance of Contamination Control for Consumer Healthcare | 2 mins |
| MLV-097 | Product Contamination in the Consumer Healthcare Industry | 2 mins |
Quality Control
| Course Code | Title | Duration |
|---|---|---|
| ELM-229 | The Fundamentals of Quality Control | 15 mins |
| ELM-719 | Ensuring Environmental Quality: A Guide to Microbiological Monitoring | 20 mins |
| ELM-721 | Microbiological Testing Methods | 20 mins |
| ELM-736 | In-Process Sampling and Testing | 15 mins |
| MLV-049 | The Importance of Environmental Monitoring | 1 min |
Isolation Technology
| Course Code | Title | Duration |
|---|---|---|
| ELM-707 | Key Isolation Technologies for Sterile Manufacturing | 15 mins |
Good Clinical Practices (GCP)
ICH E6 (R2)
| Course Code | Title | Duration |
|---|---|---|
| ELM-904 | ICH E6 – Introduction and Principles of Good Clinical Practices (GCP) (Sections 1-2) R2 | 30 mins |
| ELM-924 | ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2 | 30 mins |
| ELM-906 | ICH E6 – Investigator (Chapter 4) (R2) | 15 mins |
| ELM-914 | ICH E6 – Sponsor (Chapter 5) (R2) | 15 mins |
| ELM-915 | ICH E6 – Clinical Trial Protocol and Protocol Amendments (Chapter 6) (R2) | 15 mins |
| ELM-916 | ICH E6 – Investigator’s Brochure (Chapter 7) (R2) | 15 mins |
| ELM-917 | ICH E6 – Essential Documents (Chapter 8)(R2) | 15 mins |
| ELM-945 | Good Clinical Practice 2024 Refresher Course | 10 mins |
ICH E6 (R3)
| Course Code | Title | Duration |
|---|---|---|
| ELM-937 | The Fundamentals of Good Clinical Practice (ICH E6 R3) | 25 mins |
| ELM-932 | ICH E6 (R3) – What’s New in R3? | 15 mins |
| ELM-983 | ICH E6 (R3) – General Principles of Good Clinical Practices | 20 mins |
| ELM-980 | ICH E6 (R3) – Sponsor | 25 mins |
| ELM-981 | ICH E6 (R3) – Data Governance | 15 mins |
| ELM-982 | ICH E6 (R3) – Investigator | 10 mins |
| ELM-984 | ICH E6 (R3) – IRB/IEC | 15 mins |
| ELM-996 | ICH E6 R3 Appendices | 15 mins |
| ELM-965 | Good Clinical Practice 2025 Annual Refresher | 10 mins |
| ELM-991 | Good Clinical Practice Refresher 2026 | 10 mins |
ICH E8
| Course Code | Title | Duration |
|---|---|---|
| ELM-927 | ICH E8 Objectives, Fundamentals, and General Principles | 15 mins |
| ELM-928 | ICH E8 Section 3 – Designing Quality into Clinical Studies | 15 mins |
| ELM-929 | ICH E8 Section 4 – Drug Development Planning | 15 mins |
| ELM-940 | ICH E8 Section 5 – Design Elements and Data Sources for Clinical Studies | 10 mins |
| ELM-941 | ICH E8 Section 6 – Conduct, Safety, Monitoring and Reporting | 15 mins |
| ELM-942 | ICH E8 Section 7 – Considerations in Identifying Critical to Quality Factors | 20 mins |
Clinical Operations & Best Practices
| Course Code | Title | Duration |
|---|---|---|
| CEC-200 | Veeva GCP for Clinical Trials | |
| ELM-961 | Regulatory Submissions | 15 mins |
| ELM-405 | Serious Breaches | 15 mins |
| ELM-918 | Good Clinical Practices (GCP) – Warning Letter Trends | 15 mins |
| ELM-972 | Informed Consent | 15 mins |
| ELM-987 | European Union Clinical Trials Regulation (EU CTR) | 15 mins |
| ELM-997 | Sponsor Oversight of Outsourced Trials | 15 mins |
| ELM-998 | Clinical Trial Safety Reporting | 10 mins |
| ELM-999 | Investigator Oversight of Clinical Trials | 15 mins |
Good Laboratory Practices (GLP)
Good Pharmacovigilance Practices (GVP)
| Course Code | Title | Duration |
|---|---|---|
| ELM-920 | The Fundamentals of Good Pharmacovigilance Practices (GVP) | 15 mins |
| ELM-939 | Quality and Pharmacovigilance Systems | 15 mins |
| ELM-933 | GVP Risk Management Systems | 10 mins |
| ELM-934 | GVP PSUR (Periodic Safety Update Reports) | 15 mins |
| ELM-935 | GVP Signal Management | 15 mins |
| ELM-947 | Good Pharmacovigilance Practice 2024 Refresher Course | 10 mins |
| ELM-967 | Good Pharmacovigilance Practice 2025 Annual Refresher | 10 mins |
| ELM-993 | Good Pharmacovigilance Practice Refresher 2026 | 10 mins |
Medical Device Topics
| Course Code | Title | Duration |
|---|---|---|
| ELM-348 | In Vitro Diagnostic Medical Devices Regulation (IVDR) | 20 mins |
| ELM-320 | EU Medical Device Regulation | 15 mins |
| ELM-814 | Quality Management System Regulation (QMSR) and Global Harmonization | 15 mins |
| ELM-135 | ELM-135 MDSAP Essentials: A Global Regulatory Roadmap | 25 mins |
| ELM-801 | Principles of ISO 13485:2016 for Medical Device Safety | 20 mins |
| ELM-815 | QMSR and The Quality Management System for Medical Devices | 10 mins |
| ELM-817 | Quality Management System Regulation – Resource Management | 15 mins |
| ELM-820 | FDA-Specific Requirements within the QMSR | 15 mins |
| ELM-816 | Quality Management System Regulation – Management Responsibility | 25 mins |
| ELM-333 | ISO 14971 – The Scope of the Standard | 30 mins |
| ELM-818 | The Quality Management System Regulation – Product Realization | 15 mins |
| ELM-819 | QMSR Measurement, Analysis, and Improvement | 20 mins |
Validation Topics
| Course Code | Title | Duration |
|---|---|---|
| ELM-401 | Process Validation: Core Concepts | 15 mins |
| ELM-601 | An Introduction to Cleaning Validation | 60 mins |
| ELM-121 | Risk-based Equipment Qualification | 15 mins |
| MLV-025 | What is the Difference Between Qualification and Validation? | 1 min |
| ELM-156 | An Introduction to Medical Device Validation – Part 1 | 45 mins |
| ELM-157 | An Introduction to Medical Device Validation – Part 2 | 60 mins |
| ELM-158 | An Introduction to Medical Device Validation – Part 3 | 60 mins |
| ELM-230 | The Fundamentals of Computer System Validation | 25 mins |
| ELM-195 | Computer Software Assurance (CSA) | 15 mins |
| ELM-133 | Integrating CSA into the Software Life Cycle | 15 mins |
| ELM-162 | CSA: Applying a Risk-Benefit Approach | 15 mins |
| ELM-163 | Building the Foundational Assurance Strategy | 15 mins |
| ELM-166B | CSA: Leveraging Supplier Assurance | 20 mins |
| ELM-111 | CSV Through The Lens of CSA | 15 mins |
| MLV-034 | 10 Best Practices for Creating Solid User Requirements | 3 mins |
Process & Cleaning Validation
| Course Code | Title | Duration |
|---|---|---|
| ELM-401 | Process Validation: Core Concepts | 15 mins |
| ELM-601 | An Introduction to Cleaning Validation | 60 mins |
Commissioning, Qualification & Validation (CQV)
| Course Code | Title | Duration |
|---|---|---|
| ELM-121 | Risk-based Equipment Qualification | 15 mins |
| MLV-025 | What is the Difference Between Qualification and Validation? | 1 min |
Medical Device Validation
| Course Code | Title | Duration |
|---|---|---|
| ELM-156 | An Introduction to Medical Device Validation – Part 1 | 45 mins |
| ELM-157 | An Introduction to Medical Device Validation – Part 2 | 60 mins |
| ELM-158 | An Introduction to Medical Device Validation – Part 3 | 60 mins |
Computer System Validation (CSV)
| Course Code | Title | Duration |
|---|---|---|
| ELM-230 | The Fundamentals of Computer System Validation | 25 mins |
| ELM-195 | Computer Software Assurance (CSA) | 15 mins |
| ELM-133 | Integrating CSA into the Software Life Cycle | 15 mins |
| ELM-162 | CSA: Applying a Risk-Benefit Approach | 15 mins |
| ELM-163 | Building the Foundational Assurance Strategy | 15 mins |
| ELM-166B | CSA: Leveraging Supplier Assurance | 20 mins |
| ELM-111 | CSV Through The Lens of CSA | 15 mins |
| MLV-034 | 10 Best Practices for Creating Solid User Requirements | 3 mins |
Other Topics
Corporate Compliance & HR
Sexual Harassment & Prevention Training Series
| Course Code | Title | Duration |
|---|---|---|
| CCL-114 | Recognizing and Understanding Harassment | 15 mins |
| CCL-115 | Abusive Conduct | 15 mins |
| CCL-116 | Types of Harassment & Relationships at Work | 15 mins |
| CCL-117 | Unwelcome Conduct and the Investigation Process | 15 mins |
| CCL-118 | Harassment Impacts, Workplace Retaliation, and Responses | 10 mins |
| CCL-119 | Contributing to a Positive Workplace: Practices and Strategies | 15 mins |
| CCL-120 | Management Training: Foundations of Respectful Workplace Conduct | 25 mins |
| CCL-121 | Manager Training: Recognizing and Responding to Harassment | 15 mins |
| CCL-122 | Management Training: Harassment and Liability | 20 mins |
| CCL-123 | Management Training: Investigation Process and Workplace Retaliation | 15 mins |
Environmental Health & Safety (EHS)
| Course Code | Title | Duration |
|---|---|---|
| EHS-102 | Laboratory Physical Hazard Identification | 15 mins |
| EHS-104 | Bloodborne Pathogens | 15 mins |
| EHS-108 | PPE Safety | 5 mins |
| EHS-109 | Fire Extinguisher Training | 5 mins |
| EHS-110 | Ladder Safety | 10 mins |
| EHS-111 | Slips, Trips and Falls | 5 mins |
| EHS-112 | Hazard Communication (HazCom) | 5 mins |
| EHS-113 | Hazardous Waste Generator | 5 mins |
| EHS-115 | Lockout/Tagout (LOTO) | 10 mins |
| EHS-116 | Compressed Gas Storage & Handling | 15 mins |
| EHS-120 | Hearing Conservation and Protection | 15 mins |
| EHS-123 | Electrical Safety | 10 mins |
| EHS-124 | Hot Work | 15 mins |
| EHS-125 | Respiratory Protection | 15 mins |