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: V1.3
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
Results
Minor update: This course has been updated to align terminology with current industry trends and to improve clarity.
V1.3
Small improvement to course content
Version 1.2
Updated to make clarification in wording on one slide
Version 1.1