Fundamentals Series

The Fundamentals of Deviations

This course will give you a fundamental understanding of deviations in the life sciences.

From examining regulatory bodies to learning effective communicating all the way to closure documentation best practices, we will explore the ins and outs of what to do when things don’t go according to plan.

At the end of this course, you’ll be able to:

  • Identify and define deviations
  • Identify the bodies in the United States and European Union that regulate the handling of deviations
  • Recall the steps of a deviation management plan
  • Explain how to communicate all the necessary deviation information with colleagues
  • Describe how to close a deviation
CEU Credits: 0.1
Course Code: ELM-227
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: V 1.1
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

Results

Minor Update: Course content has been updated 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 clarify 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.
V1.1

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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