Program Description

ISO 14155:2011 - GCP Certificate

Estimated Learning Duration of the Program:
1 day
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

Program Pricing

Price1 onlyAs of 5As of 10As of 20As of 50
Price / person €309.00278.00247.00216.00Contact us
Price / person $364.62328.04291.46254.88Contact us