Change Control

The Lifecycle of a Change Control Program – Phase 1: Develop the Change Request

In regulated industries, the company must be committed to maintaining the validated status of products and compliance with applicable laws and recommended guidelines. Change management is essential to compliance and requires implementing a Change Control Program that is incorporated into the company policies and procedures. This course covers an overview of implementing a change control program, as well as Phase 1 of the lifecycle of a change control program, which focuses on proposing and developing the change request.

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CEU Credits: 0.1
Course Code: ELM-161
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 09/02/2021

Curriculum for this course

Overview
Learning Objectives
Glossary
Requirements for a Change Control Program (ICH Q10)
The Four Change Control Phases
Phase 1: Propose
Phase 2: Evaluate
Phase 3: Implement
Phase 4: Review
Propose Phase 1 Questions
Perform Change Control Phase 1 Step 1: Identify
Considerations in Developing the Change Request
Step 1: Considerations in the Change Request – The Impact Assessment
Writing the Change Request Part I
Writing the Change Request Part II
Writing the Change Request Part III
Change Control: Examples of Minor vs Major
End of Phase 1
Final Assessment
v1.1 Minor update on 01/20/2026 to fix a typo in a quiz question. Additionally, course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.0 Course released in 09/02/2021

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