CEU Credits: 0.1
Course Code: ELM-226
Duration: 20 mins
Skill Level: Basic
Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Portuguese (Brazil), Spanish (Spain)
Final Exam: Yes
Certification: Yes
Version: V1.5
Effective Date: 11/28/2022
Curriculum for this course
Course Overview
What You'll Learn
Definitions
Process Requirements
21 CFR 820 Process Requirements
ISO 13485 Process Requirements
ICH Q10 Process Requirements
Sources
Analysis
Investigation
Determining Actions
Determining Actions - Best Practices
Implementing Actions
Implementing Actions Cont.
Confirming
Confirming Cont.
Situation
Action
Outcome
What We Covered
Test Your Knowledge
v1.5 Minor update on 04/18/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.4 Minor update on 12/06/2024 to collapse the navigation menu when course begins
v1.3 Minor update on 12/06/2023 to align terminology with current industry trends and to improve clarity
v1.2 Minor update on 04/24/2023 to improve media quality
v1.1 Minor update on 03/28/2023 to improve clarity
v1.0 Course released on 02/28/2023