| CCL-103 |
Introduction to the General Data Protection Regulation (GDPR) |
15 mins |
V2.0 |
| CCL-105 |
Doing the Right Thing: Anti-Bribery |
25 mins |
V1.1 |
| CCL-106 |
HIPAA – Health Insurance Portability and Accountability Act |
15 mins |
V1.1 |
| CCL-107 |
Cybersecurity |
15 mins |
V1.0 |
| CCL-108 |
Sunshine Act |
15 mins |
V1.0 |
| CCL-109 |
Workplace Harassment and Bystander Intervention |
15 mins |
V1.1 |
| CCL-110 |
Level Up Your Leadership: Essential Attributes for Modern Managers |
20 mins |
V1.0 |
| EHS-102 |
Laboratory Physical Hazard Identification |
15 mins |
V1.1 |
| EHS-104 |
Bloodborne Pathogen |
5 mins |
V1.0 |
| EHS-108 |
PPE Safety |
5 mins |
V1.0 |
| EHS-109 |
Fire Extinguisher Training |
5 mins |
V1.0 |
| EHS-110 |
Ladder Safety |
5 mins |
V1.0 |
| EHS-111 |
Slips, Trips and Falls |
5 mins |
V1.0 |
| EHS-112 |
Hazard Communication (HazCom) |
5 mins |
V1.1 |
| EHS-113 |
Hazardous Waste Generator |
5 mins |
V1.0 |
| ELM-101 |
Good Laboratory Practices: History and Regulatory Compliance |
20 mins |
V4.1 |
| ELM-102 |
Laboratory Data Integrity |
15 mins |
V3.0 |
| ELM-106 |
How to Prepare for Internal & External Laboratory Audits |
60 mins |
V1.0 |
| ELM-107 |
How to Perform Supplier Qualification |
60 mins |
V1.0 |
| ELM-108 |
Laboratory Investigations & Deviations |
60 mins |
V1.0 |
| ELM-109 |
Performing Analytical Analysis in a Regulated Laboratory |
60 mins |
V1.0 |
| ELM-110 |
Premises, People, and Animal Welfare in GLP |
60 mins |
V2.0 |
| ELM-111 |
The Life Cycle of a Software Validation Protocol |
60 mins |
V3.0 |
| ELM-112 |
21 CFR Part 11 – An Introduction |
15 mins |
V1.2 |
| ELM-114 |
21 CFR Part 11 – Electronic Records |
45 mins |
V1.1 |
| ELM-115 |
21 CFR Part 11 – Electronic Signatures |
45 mins |
V1.1 |
| ELM-116 |
21 CFR Part 11 – 2003 Guidance |
20 mins |
V1.2 |
| ELM-117 |
CAPA and Effectiveness Checks |
20 mins |
V3.0 |
| ELM-120 |
Elevating Quality Culture through Positive Behaviors |
20 mins |
V3.1 |
| ELM-121 |
Risk Based Equipment Qualification |
15 mins |
V2.1 |
| ELM-122 |
How to be an Effective GMP Auditor – Part 1 |
45 mins |
V3.0 |
| ELM-123 |
How to be an Effective GMP Auditor – Part 2 |
35 mins |
V2.1 |
| ELM-124 |
How To Be An Effective GMP Auditor – Part 3 |
45 mins |
V1.0 |
| ELM-126 |
How to Write Effective Standard Operating Procedures (SOPs) |
60 mins |
V1.1 |
| ELM-127 |
How to Write an Effective Equipment User Requirement Specification (URS) |
60 mins |
V1.0 |
| ELM-132 |
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5 |
45 mins |
V2.1 |
| ELM-133 |
Computer System Validation – The Regulated Software Life Cycle |
60 mins |
V1.1 |
| ELM-134 |
Computer System Validation – Requirements: The Basis for Validation |
60 mins |
V1.0 |
| ELM-135 |
Medical Device Single Audit Program (MDSAP) – Part 1 |
45 mins |
V1.0 |
| ELM-136 |
Medical Device Single Audit Program (MDSAP) – Part 2 |
45 mins |
V1.0 |
| ELM-137 |
Medical Device Single Audit Program (MDSAP) – Part 3 |
45 mins |
V1.0 |
| ELM-138 |
Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4 |
60 mins |
V2.0 |
| ELM-139 |
Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7 |
60 mins |
V2.0 |
| ELM-140 |
MDSAP Country Specific Requirements (Australia) |
45 mins |
V2.0 |
| ELM-141 |
MDSAP Country Specific Requirements (Brazil) |
45 mins |
V2.0 |
| ELM-142 |
MDSAP Country Specific Requirements (Canada) |
60 mins |
V2.0 |
| ELM-143 |
MDSAP Country Specific Requirements (USA) |
60 mins |
V2.0 |
| ELM-144 |
MDSAP Country Specific Requirements (Japan) |
45 mins |
V2.0 |
| ELM-145 |
Combination Products (Drugs, Devices and Biologics) – Part 1 |
45 mins |
V2.0 |
| ELM-146 |
Combination Products (Drugs, Devices and Biologics) – Part 2 |
45 mins |
V1.0 |
| ELM-147 |
Combination Products (Drugs, Devices and Biologics) – Part 3 |
45 mins |
V1.0 |
| ELM-148 |
An Introduction to Data Integrity Awareness |
45 mins |
V1.5 |
| ELM-149A |
Computer System Validation: Periodic Review Strategies Part 1 |
45 mins |
V1.0 |
| ELM-149B |
Computer System Validation: Periodic Review Strategies Part 2 |
45 mins |
V1.0 |
| ELM-151 |
Data Integrity Awareness: Health Authorities |
45 mins |
V1.0 |
| ELM-152 |
Data Integrity Awareness: ALCOA+ |
15 mins |
V3.0 |
| ELM-153 |
Data Integrity Awareness: Good Documentation Practices |
40 min |
V1.2 |
| ELM-154 |
Data Integrity Awareness: CSV Best Practices |
45 mins |
V1.0 |
| ELM-155 |
Data Integrity Awareness – Data Governance |
45 mins |
V1.0 |
| ELM-156 |
An Introduction to Medical Device Validation – Part 1 |
45 mins |
V1.0 |
| ELM-157 |
An Introduction to Medical Device Validation – Part 2 |
60 mins |
V1.0 |
| ELM-158 |
An Introduction to Medical Device Validation – Part 3 |
60 mins |
V1.0 |
| ELM-159 |
Change Control: Regulations and Guidelines |
30 mins |
V3.0 |
| ELM-160 |
Change Control and Change Management |
45 mins |
V2.0 |
| ELM-161 |
The Lifecycle of a Change Control Program – Phase 1: Develop the Change Request |
45 mins |
V1.0 |
| ELM-162 |
Computer System Validation – Risk Management |
60 mins |
V1.0 |
| ELM-163 |
Computer System Validation – Validation Master Plan |
45 mins |
V1.0 |
| ELM-164 |
Computer System Validation – Application of the Validation Plan |
30 mins |
V1.0 |
| ELM-165A |
Computer System Validation (CSV) – Validation Testing Part 1 |
45 mins |
V1.0 |
| ELM-165B |
Computer System Validation (CSV): Validation Testing – Part 2 |
45 mins |
V1.0 |
| ELM-166A |
Computer System Validation – Maintaining the Validated State |
45 mins |
V1.1 |
| ELM-166B |
Computer System Validation – Supplier Provided Software |
45 mins |
V1.1 |
| ELM-167 |
Computer System Validation (CSV) – Special Topics |
45 mins |
V1.0 |
| ELM-174 |
The Basics of Laboratory Investigations |
45 mins |
V1.0 |
| ELM-175 |
How to Conduct a Laboratory Investigation |
45 mins |
V1.0 |
| ELM-178 |
The Lifecycle of a Change Control Program – Phase 2: Evaluate |
45 mins |
V1.0 |
| ELM-179 |
The Lifecycle of a Change Control Program – Phase 3: Implement and Phase 4: Review |
45 mins |
V1.0 |
| ELM-180 |
The Lifecycle of a Change Control Program – Examples of Change Controls, Documents & Recording Completed Changes |
30 mins |
V1.0 |
| ELM-181 |
Commissioning Qualification and Validation the Concept of CQV – Part 1 |
30 mins |
V1.0 |
| ELM-182 |
Commissioning Qualification and Validation the Concept of CQV – Part 2 |
30 mins |
V1.0 |
| ELM-183 |
Commissioning Qualification and Validation the Concept of CQV – Part 3 |
45 mins |
V1.0 |
| ELM-190 |
General Inspection Readiness |
20 mins |
V2.1 |
| ELM-191 |
Inspection Readiness: Your Role & Preparing for Inspector Interactions |
25 mins |
V1.4 |
| ELM-192 |
Protocols, SOPs, and Quality Assurance Functions in GLP Environments |
10 mins |
V1.1 |
| ELM-193 |
Test Systems, Test Articles, and Safety Endpoints in GLP Protocols |
15 mins |
v1.0 |
| ELM-194 |
GLP Records, Retention, and Disqualification |
15 mins |
V1.0 |
| ELM-195 |
Computer Software Assurance (CSA) |
15 mins |
V1.0 |
| ELM-196 |
Deviation – Initiator |
15 mins |
v1.0 |
| ELM-197 |
Deviation – Investigator |
20 mins |
V1.0 |
| ELM-201 |
cGMP – Cases from History and the Regulations |
30 mins |
V3.1 |
| ELM-202 |
Good Manufacturing Practices – QMS, Premises and Personnel |
30 mins |
V1.0 |
| ELM-203 |
cGMP – Equipment, Validation, Complaints and Self Inspection |
30 mins |
V2.0 |
| ELM-204 |
Good Manufacturing Practices – Good Practices and Quality Control |
30 mins |
V1.0 |
| ELM-205 |
21 CFR Part 211 Subpart C – Building and Facilities |
45 mins |
V1.0 |
| ELM-206 |
21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures |
45 mins |
V1.0 |
| ELM-207 |
21 CFR Part 211 Subpart H – Holding and Distribution |
30 mins |
V1.0 |
| ELM-208 |
21 CFR Part 211 Subpart F: Production and Process Controls |
45 mins |
V1.0 |
| ELM-209 |
21 CFR Part 211 Subpart G: Packaging and Labeling Control |
45 mins |
V1.0 |
| ELM-210 |
21 CFR Part 211 Subpart J – Records and Reports |
45 mins |
V1.0 |
| ELM-211 |
21 CFR Part 211 Subpart B: Organization and Personnel |
45 mins |
V1.0 |
| ELM-212 |
21 CFR Part 211 Subpart D – Equipment |
45 mins |
V1.0 |
| ELM-213 |
21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products |
45 mins |
V1.0 |
| ELM-219 |
The Fundamentals of Good Manufacturing Practices |
15 mins |
V2.2 |
| ELM-220 |
The Fundamentals of Good Documentation Practice |
15 mins |
V4.0 |
| ELM-221 |
The Fundamentals of Data Integrity |
10 mins |
V4.2 |
| ELM-222 |
The Fundamentals of Contamination Control |
20 mins |
V2.1 |
| ELM-223 |
The Fundamentals of Good Laboratory Practices (cGLP) |
20 mins |
v2.0 |
| ELM-224 |
The Fundamentals of GxP in a Regulated Environment |
20 mins |
V3.0 |
| ELM-226 |
The Fundamentals of Corrective and Preventive Actions (CAPA) |
20 mins |
V1.3 |
| ELM-227 |
The Fundamentals of Deviations |
20 mins |
V 1.1 |
| ELM-228 |
The Fundamentals of Inspection Readiness |
15 mins |
V1.1 |
| ELM-229 |
The Fundamentals of Quality Control |
15 mins |
V1.1 |
| ELM-230 |
The Fundamentals of Computer System Validation |
25 mins |
V1.2 |
| ELM-232a |
The Fundamentals of Quality Risk Management (QRM) |
20 mins |
V1.8 |
| ELM-232b |
Quality Risk Management (QRM): Global Regulations and Their Impact |
15 mins |
V1.5 |
| ELM-233 |
ICH Q10 – Management Responsibilities |
20 mins |
V1.0 |
| ELM-234 |
The Fundamentals of Good Distribution Practice |
10 mins |
V2.1 |
| ELM-235 |
Good Distribution Practices: Core Principles |
10 mins |
V2.0 |
| ELM-237 |
ICH Q9 – Quality Risk Management |
25 mins |
V1.1 |
| ELM-238 |
ICH Q9 – Risk Management Methods and Tools |
20 mins |
V1.0 |
| ELM-239 |
QRM as Part of Integrated Quality Management |
20 mins |
V1.0 |
| ELM-240 |
Good Distribution Practices: Operational Principles |
15 mins |
V2.1 |
| ELM-244 |
Human Error Prevention |
20 mins |
V1.0 |
| ELM-247 |
The Fundamentals of Change Control |
15 mins |
V1.1 |
| ELM-250 |
Change Control: Core Concepts |
20 mins |
V1.1 |
| ELM-257 |
Train the Trainer: Adult Learning Theory |
15 mins |
V1.0 |
| ELM-258 |
Supplier Quality Management |
15 mins |
v1.0 |
| ELM-259 |
Customer Complaint Handling |
15 mins |
V1.0 |
| ELM-263 |
Batch/Product Release |
15 mins |
v1.0 |
| ELM-264 |
Equipment Maintenance |
15 mins |
V1.0 |
| ELM-301 |
21 CFR Part 820 Subpart A – General Provisions |
30 mins |
V1.0 |
| ELM-302 |
21 CFR Part 820 Subpart B – Quality System Requirements |
30 mins |
V1.0 |
| ELM-303 |
21 CFR Part 820 Subpart C – Design Controls |
60 mins |
V1.1 |
| ELM-304 |
21 CFR Part 820 Subpart D – Document Controls |
45 mins |
V1.0 |
| ELM-305 |
21 CFR Part 820 Subpart E – Purchasing Controls |
45 mins |
V1.0 |
| ELM-306 |
21 CFR Part 820 Subpart F – Identification and Traceability |
60 mins |
V1.0 |
| ELM-307 |
21 CFR Part 820 Subpart G – Production and Process Controls |
45 mins |
V1.0 |
| ELM-308 |
21 CFR Part 820 Subpart H – Acceptance Activities |
45 mins |
V1.0 |
| ELM-309 |
21 CFR Part 820 Subpart I – Nonconforming Products |
60 mins |
V1.0 |
| ELM-310 |
21 CFR Part 820 Subpart J – Corrective and Preventive Action |
45 mins |
V1.0 |
| ELM-311 |
21 CFR Part 820 Subpart K: Labeling and Packaging Control |
45 mins |
V1.0 |
| ELM-312 |
21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation |
45 mins |
V1.1 |
| ELM-313 |
21 CFR Part 820 Subpart M – Records |
45 mins |
V1.0 |
| ELM-314 |
21 CFR Part 820 Subpart N – Servicing |
45 mins |
V1.0 |
| ELM-315 |
21 CFR Part 820 Subpart 0 – Statistical Techniques |
45 mins |
V1.0 |
| ELM-316 |
EU Medical Device Regulation (EU MDR) – Introduction |
60 mins |
V1.0 |
| ELM-317 |
EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions |
45 mins |
V1.0 |
| ELM-318 |
EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market |
60 mins |
V1.0 |
| ELM-319 |
EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices |
60 mins |
V1.0 |
| ELM-320 |
EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies |
45 mins |
V1.0 |
| ELM-321 |
EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity |
45 mins |
V1.0 |
| ELM-322 |
EU Medical Device Regulation (EU MDR) – Chapter 6 – Clinical Evaluation and Clinical Investigations |
45 mins |
V1.0 |
| ELM-323 |
EU Medical Device Regulation (EU MDR) – Chapter 7 – Post Market Surveillance, Vigilance and Market Surveillance |
45 mins |
V1.0 |
| ELM-324 |
EU Medical Device Regulation (EU MDR) – Chapter 8 – Cooperation Between Member States |
30 mins |
V1.0 |
| ELM-325 |
EU Medical Device Regulation (EU MDR) – Chapter 9 – Confidentiality, Data Protection, Funding and Penalties |
30 mins |
V1.0 |
| ELM-326 |
EU Medical Device Regulation (EU MDR) – Chapter 10 – Final Provisions |
30 mins |
V1.0 |
| ELM-327 |
EU Medical Device Regulation (EU MDR) – Chapters 1 to 5 |
60 mins |
V1.0 |
| ELM-328 |
EU Medical Device Regulation (EU MDR) – Chapters 6 to 10 |
60 mins |
V1.0 |
| ELM-330 |
China Food and Drug Administration’s (CFDA’s) – GMP for Medical Devices |
60 mins |
V1.0 |
| ELM-331 |
China Food and Drug Administration’s (CFDA’s) – GMP for Implantable Medical Devices |
60 mins |
V1.0 |
| ELM-333 |
ISO 14971 – The Scope of the Standard |
30 mins |
V2.1 |
| ELM-334 |
ISO 14971:2019: The Evolution and Definitions |
45 mins |
V1.0 |
| ELM-335 |
ISO 14971:2019: Basic Framework for Risk Management |
45 mins |
V1.0 |
| ELM-336 |
ISO 14971: Characterizing the Device & Identifying Hazards |
45 mins |
V1.0 |
| ELM-337 |
ISO 14971:2019: Risk Analysis, Evaluation & Control |
45 mins |
V2.0 |
| ELM-338 |
ISO 14971:2019: Different Perspectives of a Risk Management Program |
45 mins |
V1.0 |
| ELM-401 |
Process Validation: Core Concepts |
15 mins |
V2.0 |
| ELM-402 |
An Introduction to Process Validation – Part 2 |
60 mins |
V1.1 |
| ELM-404 |
Root Cause Analysis |
30 mins |
v1.0 |
| ELM-405 |
Serious Breaches |
15 mins |
v1.0 |
| ELM-501 |
Good Documentation Practices – General Rules of Data Integrity |
30 mins |
V1.0 |
| ELM-502 |
Good Documentation Practices – Making Correction to Ensure Data Integrity |
30 mins |
V1.0 |
| ELM-503 |
Good Documentation Practices – Logbook Data Integrity |
30 mins |
V1.0 |
| ELM-504 |
Good Documentation Practices – Data Integrity for General Test Results |
30 mins |
V2.0 |
| ELM-505 |
Technical Writing in a Regulated or Accredited Environment |
20 mins |
V2.0 |
| ELM-601 |
An Introduction to Cleaning Validation |
60 mins |
V2.0 |
| ELM-701 |
Types of Contamination in a GMP Environment |
15 mins |
V3.0 |
| ELM-702 |
Sources of Contamination in a GMP Environment |
10 mins |
V 3.0 |
| ELM-704 |
Contamination Control Strategies in a GMP Environment |
15 mins |
V3.0 |
| ELM-705 |
Microbiological Contamination of Pharmaceutical Products – Part 1 |
45 mins |
V1.0 |
| ELM-706 |
Microbiological Contamination of Pharmaceutical Products – Part 2 |
60 mins |
V1.0 |
| ELM-707 |
The Basic Principles of Isolator Technology |
45 mins |
V1.0 |
| ELM-708 |
Restricted Access Barrier Systems (RABS) Glove Training |
45 mins |
V1.0 |
| ELM-709 |
An Introduction to Endotoxin Control |
30 mins |
V1.0 |
| ELM-710 |
The Devastating Effects of Not Following GMP |
15 mins |
V2.2 |
| ELM-711 |
Pharmaceutical Microbiology and Industry Considerations |
30 mins |
V1.0 |
| ELM-715 |
The Use of Vaporized Hydrogen Peroxide (VHP) Chambers |
30 mins |
V1.0 |
| ELM-719 |
Microbiological Environmental Monitoring |
30 mins |
V1.0 |
| ELM-720 |
Control of Microbiological Contamination in a GMP Environment |
30 mins |
V1.0 |
| ELM-721 |
Microbiological Testing Methods |
30 mins |
V1.0 |
| ELM-725 |
The Fundamentals of Cell and Gene Therapy |
15 mins |
V1.1 |
| ELM-726 |
The Fundamentals of Biotech Manufacturing |
10 mins |
V1.0 |
| ELM-727 |
Cell Therapy (CAR T) Processing |
15 mins |
v1.0 |
| ELM-729 |
Technology Transfer to GMP Manufacturing |
20 mins |
v1.0 |
| ELM-733 |
Biotech Manufacturing: Aseptic Processing |
10 mins |
V1.1 |
| ELM-736 |
In-Process Sampling and Testing |
15 mins |
V1.0 |
| ELM-737 |
Plant and Clean Utilities for GMP Manufacturing |
15 mins |
V1.0 |
| ELM-739 |
Winning Cleanroom Behaviors |
10 mins |
V1.1 |
| ELM-742 |
Gene Therapy: Applications of Adeno-associated Viruses and Adenoviruses |
20 mins |
v1.0 |
| ELM-743 |
The Fundamentals of Quality Management Systems – Pharma |
15 mins |
V1.0 |
| ELM-801 |
ISO 13485:2016 – Chapter 1-3: Introduction |
45 mins |
V1.0 |
| ELM-802 |
ISO 13485:2016 – Chapter 4: The Quality Management System (QMS) |
60 mins |
V1.0 |
| ELM-803 |
ISO 13485:2016 – Chapter 5: Management Responsibility |
45 mins |
V1.0 |
| ELM-804 |
ISO 13485:2016 – Chapter 6: Resource Management |
45 mins |
V1.0 |
| ELM-805 |
ISO 13485:2016 Product Realization (Chapter 7 – Part A) |
60 mins |
V1.0 |
| ELM-806 |
ISO 13485:2016 – Product Realization (Chapter 7 – Part B) |
45 mins |
V1.0 |
| ELM-807 |
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A) |
45 mins |
V1.0 |
| ELM-808 |
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B) |
45 mins |
V1.0 |
| ELM-904 |
ICH E6 – Introduction and Principles of Good Clinical Practices (GCP) (Sections 1-2) R2 |
30 mins |
V1.2 |
| ELM-906 |
ICH E6 – Investigator (Chapter 4) (R2) |
15 mins |
V1.0 |
| ELM-909 |
21 CFR Part 50 Subpart B: Informed Consent of Human Subjects [Part 1] |
45 mins |
V1.0 |
| ELM-910 |
21 CFR Part 50 Subpart B: Informed Consent of Human Subjects [Part 2] |
45 mins |
V1.0 |
| ELM-914 |
ICH E6 – Sponsor (Chapter 5) (R2) |
15 mins |
V1.0 |
| ELM-915 |
ICH E6 – Clinical Trial Protocol and Protocol Amendments (Chapter 6) (R2) |
15 mins |
V1.0 |
| ELM-916 |
ICH E6 – Investigator’s Brochure (Chapter 7) (R2) |
15 mins |
V1.0 |
| ELM-917 |
ICH E6 – Essential Documents (Chapter 8)(R2) |
15 mins |
V1.0 |
| ELM-918 |
Good Clinical Practices (GCP) – Warning Letter Trends |
15 mins |
V1.1 |
| ELM-920 |
The Fundamentals of Good Pharmacovigilance Practices (GVP) |
20 mins |
V2.0 |
| ELM-922 |
Good Pharmacovigilance Practices (GVP): Updates to the European Union GVP Guidelines |
30 mins |
V1.1 |
| ELM-924 |
ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2 |
30 mins |
V1.0 |
| ELM-925 |
WHO Guidance on Good Clinical Laboratory Practices |
15 mins |
V1.0 |
| ELM-926 |
The Fundamentals of Good Clinical Practices (ICH E6 R2) |
20 mins |
V1.3 |
| ELM-927 |
ICH E8 Objectives, Fundamentals, and General Principles |
15 mins |
V1.0 |
| ELM-928 |
ICH E8 Section 3 – Designing Quality into Clinical Studies |
15 mins |
V1.0 |
| ELM-929 |
ICH E8 Section 4 – Drug Development Planning |
15 mins |
v1.0 |
| ELM-931 |
Annual GxP Refresher Training (2023) |
15 mins |
V1.2 |
| ELM-933 |
GVP Risk Management Systems |
10 mins |
V1.0 |
| ELM-934 |
GVP PSUR (Periodic Safety Update Reports) |
15 mins |
V1.1 |
| ELM-935 |
GVP Signal Management |
15 mins |
V1.0 |
| ELM-939 |
Quality and Pharmacovigilance Systems |
15 mins |
V1.1 |
| ELM-940 |
ICH E8 Section 5 – Design Elements and Data Sources for Clinical Studies |
10 mins |
v1.0 |
| ELM-944 |
Good Manufacturing Practice Refresher Course |
5 mins |
V1.1 |
| ELM-945 |
Good Clinical Practice Refresher Course |
5 mins |
V1.1 |
| ELM-946 |
Good Laboratory Practice Refresher Course |
3 mins |
V1.1 |
| ELM-947 |
Good Pharmacovigilance Practice Refresher Course |
5 mins |
V1.0 |
| ELM-948 |
Good Distribution Practice Refresher Course |
5 mins |
V1.0 |
| ELM-949 |
GxP Hot Topics: Cybersecurity Refresher Course |
5 mins |
V1.0 |
| ELM-950 |
Good Documentation Practice Refresher Course |
5 mins |
V1.0 |
| ELM-951 |
Data Integrity Refresher Course |
5 mins |
V1.0 |
| ELM-960 |
Recalls and Consent Decrees |
20 mins |
V1.0 |
| ELM-961 |
Regulatory Submissions |
15 mins |
V1.0 |