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: 28/11/2022
Curriculum for this course
Course Overview
30 secs
What You'll Learn
15 secs
Definitions
2 min
Process Requirements
1 min 2 secs
21 CFR 820 Process Requirements
2 min 1 secs
ISO 13485 Process Requirements
1 min 30 secs
ICH Q10 Process Requirements
45 secs
Sources
1 min 30 secs
Analysis
1 min
Investigation
1 min
Determining Actions
1 min
Determining Actions - Best Practices
1 min 30 secs
Implementing Actions
1 min
Implementing Actions Cont.
45 secs
Confirming
1 min
Confirming Cont.
15 secs
Situation
30 secs
Action
1 min 45 secs
Outcome
30 secs
What We Covered
15 secs
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