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4 | Browse our extensive catalog of GxP, Compliance & Regulatory training | |||||||||||||||||||||||
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8 | Code | Version | Course Name and LearnGxP.com link🔗 | Duration (minutes) | Current Status | Course Availability: | Industry | |||||||||||||||||
9 | Annual Refresher Training | |||||||||||||||||||||||
10 | 2024 Annual Refresher Courses |An 8-part Interactive Series | Pharma & Biotech | ||||||||||||||||||||||
11 | ELM-944 | 1.1 | Good Manufacturing Practice | 5 | Pharma & Biotech | |||||||||||||||||||
12 | ELM-945 | Good Clinical Practice | 5 | Pharma & Biotech | ||||||||||||||||||||
13 | ELM-946 | 1.1 | Good Laboratory Practice | 5 | Pharma & Biotech | |||||||||||||||||||
14 | ELM-947 | Good Pharmacovigilance Practice | 5 | Pharma & Biotech | ||||||||||||||||||||
15 | ELM-948 | Good Distribution Practice | 5 | Live| March 2024 Release | Pharma & Biotech | |||||||||||||||||||
16 | ELM-949 | GxP Hot Topics: Cybersecurity | 5 | Pharma & Biotech | ||||||||||||||||||||
17 | ELM-950 | Good Documentation Practice | 5 | Pharma & Biotech | ||||||||||||||||||||
18 | ELM-951 | Data Integrity Refresher Course | 5 | Pharma & Biotech | ||||||||||||||||||||
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20 | ELM-931 | 1.2 | Annual GxP Refresher Training (2023) | 15 | Live | July 2023 Release | Pharma & Biotech | ||||||||||||||||||
21 | The Fundamentals of GxP Series | |||||||||||||||||||||||
22 | 🌐 | ELM-219 | 2.1 | The Fundamentals of Good Manufacturing Practices (cGMP) | 15 | Live| March 2024 Redesign ⭐ | Pharma | |||||||||||||||||
23 | 🌐 | ELM-220 | 4.0 | The Fundamentals of Good Documentation Practices (GDocP) | 15 | Live|April 2024 Redesign⭐ | Pharma & Med Tech | |||||||||||||||||
24 | 🌐 | ELM-221 | 4.2 | The Fundamentals of Data Integrity | 10 | Live| March 2024 Redesign ⭐ | Pharma & Med Tech | |||||||||||||||||
25 | 🌐 | ELM-222 | 2.1 | The Fundamentals of Contamination Control | 15 | Live | Live | Pharma & Med Tech | ||||||||||||||||
26 | 🌐 | ELM-223 | 1.4 | The Fundamentals of Good Laboratory Practices | 15 | Live | Live | Pharma | ||||||||||||||||
27 | 🌐 | ELM-224 | 3.0 | The Fundamentals of GxP in a Regulated Environment - Pharma | 15 | Live | Live | Pharma | ||||||||||||||||
28 | 🌐 | ELM-226 | 1.3 | The Fundamentals of Corrective and Preventive Actions (CAPA) | 15 | Live | Live | Pharma & Med Tech | ||||||||||||||||
29 | 🌐 | ELM-227 | 1.1 | The Fundamentals of Deviations | 15 | Live | Live | Pharma & Med Tech | ||||||||||||||||
30 | 🌐 | ELM-228 | 1.1 | The Fundamentals of Inspection Readiness | 15 | Live | Live | Pharma & Med Tech | ||||||||||||||||
31 | 🌐 | ELM-229 | 1.1 | The Fundamentals of Quality Control (QC) | 15 | Live | Live | Pharma & Med Tech | ||||||||||||||||
32 | 🌐 | ELM-230 | 1.1 | The Fundamentals of Computer System Validation (CSV) | 15 | Live | Live | Pharma & Med Tech | ||||||||||||||||
33 | ELM-232a | 1.6 | The Fundamentals of Quality Risk Management (QRM) | 20 | Live | Live | Pharma | |||||||||||||||||
34 | ELM-232b | 1.4 | Quality Risk Management (QRM): Global Regulations and Their Impact | 20 | Live | Live | Pharma | |||||||||||||||||
35 | ELM-247 | 1.0 | The Fundamentals of Change Control | 15 | Live| August 2023 New Release | Pharma & Med Tech | ||||||||||||||||||
36 | 🌐 | ELM-926 | 1.3 | The Fundamentals of Good Clinical Practices (as of ICH E6 R2) | 20 | Live | Live | Pharma | ||||||||||||||||
37 | ELM-937 | - | The Fundamentals of Good Clinical Practices (as of ICH E6 R3) | - | In Development | 2024 |When R3 Live | Pharma | |||||||||||||||||
38 | TBD | - | The Fundamentals of Good Distribution Practices (GDP) | - | Tech Writing Not Started | TBD | Pharma & Med Tech | |||||||||||||||||
39 | TBD | - | The Fundamentals of Pharmacovigilance (GVP) | - | Tech Writing Not Started | TBD | Pharma | |||||||||||||||||
40 | ELM-255 | 1.0 | The Fundamentals of Software Testing in a Regulated Environment | - | Tech Writing Complete | TBD | Pharma & Med Tech | |||||||||||||||||
41 | ELM-930 | - | The Fundamentals of Inspection Readiness for GCP | - | Tech Writing Complete | 2024 | Pharma | |||||||||||||||||
42 | ELM-195 | 1.0 | Computer Software Assurance (CSA) | 15 | Live| January 2024 New Release | Pharma & Med Tech | ||||||||||||||||||
43 | ELM-723 | - | The Fundamentals of Sterile Manufacturing | - | Tech Writing Complete | 2024 | Pharma | |||||||||||||||||
44 | ELM-725 | 1.0 | The Fundamentals of Cell and Gene Therapy | 15 | Live| August 2023 New Release | Biotech | ||||||||||||||||||
45 | ELM-726 | 1.0 | The Fundamentals of Biotech Manufacturing | 10 | Live| January 2024 New Release | Biotech | ||||||||||||||||||
46 | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) | |||||||||||||||||||||||
47 | ELM-233 | 1.0 | ICH Q10 – Management Responsibilities | 20 | Live| January 2024 New Release | Pharma | ||||||||||||||||||
48 | ELM-236 | - | ICH Q10 – Pharmaceutical Quality Systems | - | In Development Soon | Q1 2024 | Pharma | |||||||||||||||||
49 | ELM-237 | 1.0 | ICH Q9 - Quality Risk Management | 20 | Live| August 2023 New Release | Pharma | ||||||||||||||||||
50 | ELM-238 | 1.0 | ICH Q9 - Risk Management Methods and Tools | 20 | Live| October 2023 New Release | Pharma | ||||||||||||||||||
51 | ELM-239 | 1.0 | ICH Q9 - QRM as Part of Integrated Quality Management | 20 | Live| December 2023 New Release | Pharma | ||||||||||||||||||
52 | ELM-243 | - | ICH Q8 - Pharmaceutical Development | - | Tech Writing Complete | TBD | Pharma | |||||||||||||||||
53 | ELM-246 | - | ICH Q7 - GMP for API (Part 1): Quality Management | - | Tech Writing Complete | TBD | Pharma | |||||||||||||||||
54 | ELM-251 | - | ICH Q7 - GMP for API (Part 2): Operational Areas and Equipment | - | Tech Writing Complete | TBD | Pharma | |||||||||||||||||
55 | ELM-252 | - | ICH Q7 - GMP for API (Part 3): Production Process | - | Tech Writing Complete | TBD | Pharma | |||||||||||||||||
56 | ELM-253 | - | ICH Q7 - GMP for API (Part 4): Special Cases | - | Tech Writing In Progress | TBD | Pharma | |||||||||||||||||
57 | 21 CFR Part 11 | |||||||||||||||||||||||
58 | ELM-112 | 1.0 | 21 CFR Part 11 - An Introduction | 45 | Live | Live | Pharma & Med Tech | |||||||||||||||||
59 | ELM-114 | 1.0 | 21 CFR Part 11 - Electronic Records | 45 | Live | Live | Pharma & Med Tech | |||||||||||||||||
60 | ELM-115 | 1.0 | 21 CFR Part 11 - Electronic Signatures | 45 | Live | Live | Pharma & Med Tech | |||||||||||||||||
61 | ELM-116 | 1.1 | 21 CFR Part 11 - Guidance | 30 | Live | Live | Pharma & Med Tech | |||||||||||||||||
62 | 21 CFR Part 820 | |||||||||||||||||||||||
63 | ELM-301 | 1.0 | 21 CFR Part 820 Subpart A - General Provisions | 30 | Live | Live | Med Tech | |||||||||||||||||
64 | ELM-302 | 1.0 | 21 CFR Part 820 Subpart B - Quality System Requirements | 30 | Live | Live | Med Tech | |||||||||||||||||
65 | ELM-303 | 1.0 | 21 CFR Part 820 Subpart C - Design Controls | 30 | Live | Live | Med Tech | |||||||||||||||||
66 | ELM-304 | 1.0 | 21 CFR Part 820 Subpart D - Document Controls | 30 | Live | Live | Med Tech | |||||||||||||||||
67 | ELM-305 | 1.0 | 21 CFR Part 820 Subpart E - Purchasing Controls | 30 | Live | Live | Med Tech | |||||||||||||||||
68 | ELM-306 | 1.0 | 21 CFR Part 820 Subpart F - Identification and Traceability | 30 | Live | Live | Med Tech | |||||||||||||||||
69 | ELM-307 | 1.0 | 21 CFR Part 820 Subpart G - Production and Process Controls | 30 | Live | Live | Med Tech | |||||||||||||||||
70 | ELM-308 | 1.0 | 21 CFR Part 820 Subpart H - Acceptance Activities | 30 | Live | Live | Med Tech | |||||||||||||||||
71 | ELM-309 | 1.0 | 21 CFR Part 820 Subpart I - Nonconforming Products | 30 | Live | Live | Med Tech | |||||||||||||||||
72 | ELM-310 | 1.0 | 21 CFR Part 820 Subpart J - Corrective and Preventative Action | 30 | Live | Live | Med Tech | |||||||||||||||||
73 | ELM-311 | 1.0 | 21 CFR Part 820 Subpart K - Labeling and Packaging Controls | 30 | Live | Live | Med Tech | |||||||||||||||||
74 | ELM-312 | 1.1 | 21 CFR Part 820 Subpart L - Handling, Storage, Distribution, and Installation | 30 | Live | Live | Med Tech | |||||||||||||||||
75 | ELM-313 | 1.0 | 21 CFR Part 820 Subpart M - Records | 30 | Live | Live | Med Tech | |||||||||||||||||
76 | ELM-314 | 1.0 | 21 CFR Part 820 Subpart N - Servicing | 30 | Live | Live | Med Tech | |||||||||||||||||
77 | ELM-315 | 1.0 | 21 CFR Part 820 Subpart O - Statistical Techniques | 30 | Live | Live | Med Tech | |||||||||||||||||
78 | TBD | - | An Introduction to 21 CFR Part 820 | - | Tech Writing Not Started | TBD | Med Tech | |||||||||||||||||
79 | Good Manufacturing Practices (cGMP) - Beginners | |||||||||||||||||||||||
80 | ELM-710 | 2.1 | The Devastating Effects of Not Following GMP | 15 | Live | Live | Pharma & Med Tech | |||||||||||||||||
82 | Good Manufacturing Practices (cGMP) - Intermediate | |||||||||||||||||||||||
84 | ELM-201 | 3.0 | cGMP Cases From History and the Regulations | 30 | Live | Live | Pharma | |||||||||||||||||
85 | ELM-202 | 2.1 | cGMP QMS, Premises & Personnel | 30 | Live | Live | Pharma | |||||||||||||||||
86 | ELM-203 | 2.0 | cGMP Equipment, Validation, Complaints & Self-Inspection | 30 | Live | Live | Pharma | |||||||||||||||||
87 | ELM-204 | 1.0 | cGMP Good Practices and Quality Control | 30 | Live | Live | Pharma | |||||||||||||||||
88 | Good Manufacturing Practices (cGMP) - 21 CFR Part 211 | |||||||||||||||||||||||
89 | ELM-211 | 1.0 | 21 CFR Part 211 Subpart B – Organization and Personnel | 30 | Live | Live | Pharma | |||||||||||||||||
90 | ELM-205 | 1.0 | 21 CFR Part 211 Subpart C - Buildings and Facilities | 30 | Live | Live | Pharma | |||||||||||||||||
91 | ELM-212 | 1.0 | 21 CFR Part 211 Subpart D - Equipment | 30 | Live | Live | Pharma | |||||||||||||||||
92 | ELM-206 | 1.0 | 21 CFR Part 211 Subpart E - Control of Components and Drug Product Containers and Closures | 30 | Live | Live | Pharma | |||||||||||||||||
93 | ELM-208 | 1.0 | 21 CFR Part 211 Subpart F - Production and Process Controls | 30 | Live | Live | Pharma | |||||||||||||||||
94 | ELM-209 | 1.0 | 21 CFR Part 211 Subpart G: Packaging and Labeling Control | 30 | Live | Live | Pharma | |||||||||||||||||
95 | ELM-207 | 1.0 | 21 CFR Part 211 Subpart H - Holding and Distribution | 30 | Live | Live | Pharma | |||||||||||||||||
96 | ELM-210 | 1.0 | 21 CFR Part 211 Subpart J - Records and Reports | 30 | Live | Live | Pharma | |||||||||||||||||
97 | ELM-213 | 1.0 | 21 CFR Part 211 Subpart K - Returned and Salvaged Drug Products | 30 | Live | Live | Pharma | |||||||||||||||||
98 | Good Manufacturing Practices (cGMP) - Eudralex Volume 4 | |||||||||||||||||||||||
99 | ELM-260 | 1.0 | Eudralex Volume 4 GMP - Introduction | 30 | Tech Writing Complete | TBD | Pharma | |||||||||||||||||
100 | TBD | 1.0 | Eudralex Volume 4 GMP – Chapters 1 to 3 | 30 | Tech Writing In Progress | TBD | Pharma | |||||||||||||||||
101 | TBD | 1.0 | Eudralex Volume 4 GMP – Chapters 4 to 6 | 30 | Tech Writing In Progress | TBD | Pharma | |||||||||||||||||
102 | TBD | 1.0 | Eudralex Volume 4 GMP – Chapters 7 to 9 | 30 | Tech Writing In Progress | TBD | Pharma |