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

Book a Demo

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: 21/12/2022

Curriculum for this course

Course Introduction

Course Overview

20 secs

What You'll Learn

25 secs

What is a Deviation?

Examples

51 secs

Regulatory Requirements

Steps to Implementing a Deviation Plan

Deviation Management Plan

15 secs

Who Will Handle the Deviation

31 secs

Allowed Time to Report a Deviation

18 secs

Required Information in the Deviation Description

38 secs

Deviation Recording

42 secs

Categorization of the Deviation

1 min 41 secs

Method Used for Root Cause Analysis

38 secs

CAPA's

1 min 53 secs

Deviation Communication

Part One

55 secs

Part Two

50 secs

Deviation Archiving, Storage and Review

Archiving

1 min 45 secs

Review

1 min 1 secs

Deviation Closure

Closure Documentation

49 secs

Closure Communication

14 secs

Real Life Impact of Deviation

Situation

1 min 30 secs

Action

1 min 1 secs

Outcome

59 secs

Conclusion

What We Covered

26 secs

Test Your Knowledge

Results

Revision History

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