Change Control

The Lifecycle of a Change Control Program – Examples of Change Controls, Documents & Recording Completed Changes

In this course, we will focus on providing a better understanding of concepts of change control that we’ve discussed thus far within this program through the use of detailed examples of the application of change control within the manufacturing environment.

CEU Credits: 0.1

Course Code: ELM-180

Duration: 30 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Program Introduction

Overview

Learning Objectives

Glossary

Revalidation and Change Control

Revalidation and Change Control

Example: Manufacturing Change Control

Manufacturing Example: Change Control Step 1 – Describe the Change

Manufacturing Example: Step 2 – Initial impact Assessment

Manufacturing Example: Change Request

Manufacturing Example: The Risk Assessment

Manufacturing Example: SMEs

Manufacturing Example: The Change Control Proposal

Document Control and Change Control

Considerations for Document Changes

Change Control and Document Control for Document Changes

Change Control Records: Mandatory Information for Documentation

Documenting the Record of Change Control Activities

Final Change Control Record for Review: Archival and Linking

Conclusion

Final Assessment

Certification

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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