ISO 14155:2011 - GCP Certificate
Estimated Learning Duration of the Program:
1 dayProgram Description
Program Description:
This program provides an in-depth and up-to-date review of the ISO 14155: 2011 standard.
It covers the following topics:
- Ethical considerations
- Clinical investigation planning
- Conduct and close outs
- Sponsor and investigator responsibilities
- Gap analysis with 21 CFR 812 and J-GCP
This program was created by Danielle Giroud, WMDO’s clinical expert and TC 194 WG4 ISO 14155 convener.
Learning Objectives:
Upon successfully completing this program, learners will be able to:
- Comprehend and apply ISO 14155 requirements as good clinical practice guidance for medical device clinical investigations
- Implement ISO 14155’s principles in a clinical department quality system
| Course Title Click on a title to view course description | ID | Duration |
|---|---|---|
| ISO 14155:2011- Scope | 61 | 20 |
| ISO 14155:2011 - Ethical Considerations | 62 | 20 |
| ISO 14155:2011 - Clinical Investigation Planning | 63 | 30 |
| ISO 14155:2011 - Clinical Investigation Conduct | 64 | 40 |
| ISO 14155:2011 - Clinical Investigation Close Out | 65 | 20 |
| ISO 14155:2011 - Responsibilities of Sponsor | 66 | 45 |
| ISO 14155:2011 - Responsibilities of Principal Investigator | 67 | 30 |
Program Pricing
| Price | 1 only | As of 5 | As of 10 | As of 20 | As of 50 |
|---|---|---|---|---|---|
| Price / person € | 309.00 | 278.00 | 247.00 | 216.00 | Contact us |
| Price / person $ | 364.62 | 328.04 | 291.46 | 254.88 | Contact us |
