A | B | C | D | F | G | H | J | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | AA | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | ||||||||||||||||||||||||
2 | ||||||||||||||||||||||||
3 | ||||||||||||||||||||||||
4 | Browse our extensive catalog of GxP, Compliance & Regulatory training | |||||||||||||||||||||||
5 | ||||||||||||||||||||||||
6 | ||||||||||||||||||||||||
7 | ||||||||||||||||||||||||
8 | Code | Version | Course Name and Link to Website | Duration | Current Status | Course Availability: | Industry | |||||||||||||||||
10 | The Fundamentals of GxP Series | |||||||||||||||||||||||
11 | ELM-219 | 1.2 | The Fundamentals of Good Manufacturing Practices (cGMP) | 15 mins | Live | Live | Pharma | |||||||||||||||||
12 | ELM-220 | 2.1 | The Fundamentals of Good Documentation Practices (GDP/GDocP) | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
13 | ELM-221 | 2.1 | The Fundamentals of Data Integrity | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
14 | ELM-222 | 1.2 | The Fundamentals of Contamination Control | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
15 | ELM-223 | 1.3 | The Fundamentals of Good Laboratory Practices | 15 mins | Live | Live | Pharma | |||||||||||||||||
16 | ELM-224 | 1.0 | The Fundamentals of GxP in a Regulated Environment - Pharma | 15 mins | Live | Live | Pharma | |||||||||||||||||
17 | ELM-226 | 1.2 | The Fundamentals of Corrective and Preventive Actions (CAPA) | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
18 | ELM-227 | 1.0 | The Fundamentals of Deviations | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
19 | ELM-228 | 1.1 | The Fundamentals of Inspection Readiness | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
20 | ELM-229 | 1.0 | The Fundamentals of Quality Control (QC) | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
21 | ELM-230 | 1.0 | The Fundamentals of Computer System Validation (CSV) | 15 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
22 | ELM-247 | TBD | The Fundamentals of Change Control | TBD | In Development | Q3 2023 | Pharma & Med Tech | |||||||||||||||||
23 | ELM-926 | 1.1 | The Fundamentals of Good Clinical Practices (GCP) | 15 mins | Live | Live | Pharma | |||||||||||||||||
24 | TBD | TBD | The Fundamentals of Good Distribution Practices (GDP) | TBD | Script Not Started | 2023 | Pharma & Med Tech | |||||||||||||||||
25 | TBD | TBD | The Fundamentals of Pharmacovigilance (GVP) | TBD | Script Not Started | 2023 | Pharma | |||||||||||||||||
26 | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) | |||||||||||||||||||||||
27 | ELM-233 | TBD | ICH Q10 – Management Responsibilities | 20 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
28 | ELM-236 | TBD | ICH Q10 – Pharmaceutical Quality Systems | 20 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
29 | ELM-237 | TBD | ICH Q9 - Quality Risk Management | 20 mins | In Development | Q2/Q3 2023 | Pharma | |||||||||||||||||
30 | ELM-238 | TBD | Risk Management Methods and Tools | 20 mins | In Development Soon | Q3/Q4 2023 | Pharma | |||||||||||||||||
31 | ELM-239 | TBD | QRM as Part of Integrated Quality Management | 20 mins | In Development Soon | Q3/Q4 2023 | Pharma | |||||||||||||||||
32 | ELM-232a | 1.4 | Fundamentals of Quality Risk Management Part 1 | 20 mins | Live | Live | Pharma | |||||||||||||||||
33 | ELM-232b | 1.2 | Fundamentals of Quality Risk Management Part 2 | 20 mins | Live | Live | Pharma | |||||||||||||||||
34 | ELM-243 | TBD | ICH Q8 - Pharmaceutical Development | 20 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
35 | ELM-246 | TBD | ICH Q7 - GMP for API (Part 1): Quality Management | 20 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
36 | ELM-251 | TBD | ICH Q7 - GMP for API (Part 2): Operational Areas and Equipment | 20 mins | Script In Progress | 2023 | Pharma | |||||||||||||||||
37 | ELM-252 | TBD | ICH Q7 - GMP for API (Part 3): Production Process | 20 mins | Script In Progress | 2023 | Pharma | |||||||||||||||||
38 | ELM-253 | TBD | ICH Q7 - GMP for API (Part 4): Storage and Distribution | 20 mins | Script In Progress | 2023 | Pharma | |||||||||||||||||
39 | 21 CFR Part 11 | |||||||||||||||||||||||
40 | ELM-112 | 1.0 | 21 CFR Part 11 - An Introduction | 45 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
41 | ELM-114 | 1.0 | 21 CFR Part 11 - Electronic Records | 45 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
42 | ELM-115 | 1.0 | 21 CFR Part 11 - Electronic Signatures | 45 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
43 | ELM-116 | 1.1 | 21 CFR Part 11 - Guidance | 30 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
44 | 21 CFR Part 820 | |||||||||||||||||||||||
45 | ELM-301 | 1.0 | 21 CFR Part 820 Subpart A - General Provisions | 30 mins | Live | Live | Med Tech | |||||||||||||||||
46 | ELM-302 | 1.0 | 21 CFR Part 820 Subpart B - Quality System Requirements | 30 mins | Live | Live | Med Tech | |||||||||||||||||
47 | ELM-303 | 1.0 | 21 CFR Part 820 Subpart C - Design Controls | 30 mins | Live | Live | Med Tech | |||||||||||||||||
48 | ELM-304 | 1.0 | 21 CFR Part 820 Subpart D - Document Controls | 30 mins | Live | Live | Med Tech | |||||||||||||||||
49 | ELM-305 | 1.0 | 21 CFR Part 820 Subpart E - Purchasing Controls | 30 mins | Live | Live | Med Tech | |||||||||||||||||
50 | ELM-306 | 1.0 | 21 CFR Part 820 Subpart F - Identification and Traceability | 30 mins | Live | Live | Med Tech | |||||||||||||||||
51 | ELM-307 | 1.0 | 21 CFR Part 820 Subpart G - Production and Process Controls | 30 mins | Live | Live | Med Tech | |||||||||||||||||
52 | ELM-308 | 1.0 | 21 CFR Part 820 Subpart H - Acceptance Activities | 30 mins | Live | Live | Med Tech | |||||||||||||||||
53 | ELM-309 | 1.0 | 21 CFR Part 820 Subpart I - Nonconforming Products | 30 mins | Live | Live | Med Tech | |||||||||||||||||
54 | ELM-310 | 1.0 | 21 CFR Part 820 Subpart J - Corrective and Preventative Action | 30 mins | Live | Live | Med Tech | |||||||||||||||||
55 | ELM-311 | 1.0 | 21 CFR Part 820 Subpart K - Labeling and Packaging Controls | 30 mins | Live | Live | Med Tech | |||||||||||||||||
56 | ELM-312 | 1.0 | 21 CFR Part 820 Subpart L - Handling, Storage, Distribution, and Installation | 30 mins | Live | Live | Med Tech | |||||||||||||||||
57 | ELM-313 | 1.0 | 21 CFR Part 820 Subpart M - Records | 30 mins | Live | Live | Med Tech | |||||||||||||||||
58 | ELM-314 | 1.0 | 21 CFR Part 820 Subpart N - Servicing | 30 mins | Live | Live | Med Tech | |||||||||||||||||
59 | ELM-315 | 1.0 | 21 CFR Part 820 Subpart O - Statistical Techniques | 30 mins | Live | Live | Med Tech | |||||||||||||||||
60 | TBD | TBD | An Introduction to 21 CFR Part 820 | 30 mins | Script Not Started | TBD | Med Tech | |||||||||||||||||
61 | Good Manufacturing Practices (cGMP) - Beginners | |||||||||||||||||||||||
62 | ELM-710 | 1.0 | The Devastating Effects of Not Following GMP | 30 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
63 | ELM-722 | 1.0 | An Introduction to GMP | 45 mins | Live | Live | Pharma | |||||||||||||||||
64 | Good Manufacturing Practices (cGMP) - Intermediate | |||||||||||||||||||||||
65 | ELM-103 | 1.0 | Good Manufacturing Practices (cGMP) [Replaced with ELM-201 to 204] | 90 mins | Retired | Retired | ||||||||||||||||||
66 | ELM-201 | 3.0 | cGMP Cases From History and the Regulations | 30 mins | Live | Live | Pharma | |||||||||||||||||
67 | ELM-202 | 2.1 | cGMP QMS, Premises & Personnel | 30 mins | Live | Live | Pharma | |||||||||||||||||
68 | ELM-203 | 1.0 | cGMP Equipment, Validation, Complaints & Self-Inspection | 30 mins | Live | Live | Pharma | |||||||||||||||||
69 | ELM-204 | 1.0 | cGMP Good Practices and Quality Control | 30 mins | Live | Live | Pharma | |||||||||||||||||
70 | Good Manufacturing Practices (cGMP) - 21 CFR Part 211 | |||||||||||||||||||||||
71 | ELM-211 | 1.0 | 21 CFR Part 211 Subpart B – Organization and Personnel | 30 mins | Live | Live | Pharma | |||||||||||||||||
72 | ELM-205 | 1.0 | 21 CFR Part 211 Subpart C - Buildings and Facilities | 30 mins | Live | Live | Pharma | |||||||||||||||||
73 | ELM-212 | 1.0 | 21 CFR Part 211 Subpart D - Equipment | 30 mins | Live | Live | Pharma | |||||||||||||||||
74 | ELM-206 | 1.0 | 21 CFR Part 211 Subpart E - Control of Components and Drug Product Containers and Closures | 30 mins | Live | Live | Pharma | |||||||||||||||||
75 | ELM-208 | 1.0 | 21 CFR Part 211 Subpart F - Production and Process Controls | 30 mins | Live | Live | Pharma | |||||||||||||||||
76 | ELM-209 | 1.0 | 21 CFR Part 211 Subpart G: Packaging and Labeling Control | 30 mins | Live | Live | Pharma | |||||||||||||||||
77 | ELM-207 | 1.0 | 21 CFR Part 211 Subpart H - Holding and Distribution | 30 mins | Live | Live | Pharma | |||||||||||||||||
78 | ELM-210 | 1.0 | 21 CFR Part 211 Subpart J - Records and Reports | 30 mins | Live | Live | Pharma | |||||||||||||||||
79 | ELM-213 | 1.0 | 21 CFR Part 211 Subpart K - Returned and Salvaged Drug Products | 30 mins | Live | Live | Pharma | |||||||||||||||||
80 | Behavioural Based Quality (BBQ) | |||||||||||||||||||||||
81 | ELM-120 | 1.0 | Behavioural Based Quality (BBQ) for a GMP Environment | 30 mins | Live | Live | Pharma & Med Tech | |||||||||||||||||
82 | GMP Warning Letter Trends | |||||||||||||||||||||||
83 | ELM-214 | 1.0 | GMP - FDA Citations and Warning Letters Trends - Lessons Learned - Part 1 | 30 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
84 | ELM-215 | 1.0 | GMP - FDA Citations and Warning Letters Trends - Lessons Learned - Part 2 | 30 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
85 | ELM-216 | 1.0 | GMP - FDA Citations and Warning Letters Trends - Lessons Learned - Part 3 | 30 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
86 | Change Control | |||||||||||||||||||||||
87 | ELM-250 | 1.0 | Pharmaceutical Change Control | 30 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
88 | ELM-231 | TBD | Pharmaceutical Change Control - Advanced | 30 mins | Script Complete | 2023 | Pharma | |||||||||||||||||
89 | Customer Complaints | |||||||||||||||||||||||
90 | TBD | 1.0 | Customer Complaints | 30 mins | Script In Progress | 2023 | Pharma | |||||||||||||||||
91 | Train the Trainer | |||||||||||||||||||||||
92 | TBD | 1.0 | Train the Trainer | 30 mins | Script In Progress | 2023 | Pharma & Med Tech | |||||||||||||||||
93 | Human Error Prevention | |||||||||||||||||||||||
94 | ELM-244 | 1.0 | Human Error Prevention | 30 mins | In Development | Q2 2023 | Pharma & Med Tech | |||||||||||||||||
95 | Good Distribution Practices (GDP) | |||||||||||||||||||||||
96 | ELM-234 | 1.4 | Good Distribution Practices in Pharma (GDP) - Part 1 | 30 mins | Live | Live | Pharma | |||||||||||||||||
97 | ELM-235 | 1.6 | Good Distribution Practices in Pharma (GDP) - Part 2 | 30 mins | Live | Live | Pharma | |||||||||||||||||
98 | ELM-240 | 1.1 | Good Distribution Practices in Pharma (GDP) - Part 3 | 31 mins | Live | Live | Pharma | |||||||||||||||||
99 | Good Manufacturing Practices (cGMP) - China CFDA (Medical Device) | |||||||||||||||||||||||
100 | ELM-330 | 1.0 | China Food and Drug Administration’s (CFDA’s) - GMP for Medical Devices | 45 mins | Live | Live | Med Tech | |||||||||||||||||
101 | ELM-331 | 1.0 | China Food and Drug Administration’s (CFDA’s) - GMP for Implantable Medical Devices | 45 mins | Live | Live | Med Tech |