CEU Credits: 0.1
Course Code: ELM-227
Duration: 20 mins
Skill Level: Basic
Language: Chinese (Simplified), Dutch, English, French (France), German, Italian, Japanese, Polish, Portuguese (Brazil), Russian, Spanish (Spain), Swedish
Final Exam: Yes
Certification: Yes
Version: V1.3
Effective Date: 12/21/2022
Curriculum for this course
Course Overview
What You'll Learn
Examples
Regulatory Requirements
Deviation Management Plan
Who Will Handle the Deviation
Allowed Time to Report a Deviation
Required Information in the Deviation Description
Deviation Recording
Categorization of the Deviation
Method Used for Root Cause Analysis
CAPA's
Part One
Part Two
Archiving
Review
Closure Documentation
Closure Communication
Situation
Action
Outcome
What We Covered
Test Your Knowledge
v1.3 Minor update on 08/14/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.2 Minor update on 12/02/2024 to collapse the navigation menu when course begins
v1.1 Minor update on 12/08/2023 to update course content for clarification. A note has been added that different terms may be used in a learner’s organization, additional examples of deviations across the GxP environment have been given, and categorization of deviations has been changed to classification of deviations. Additional language has been added to clarity that not all firms use the “incident” level of classification. Content regarding short- and long-term actions has been removed to focus the course on deviations.
v1.0 Course released in 2021