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.

CEU Credits: 0.1

Course Code: ELM-161

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Program Introduction

Overview

Learning Objectives

Glossary

Implementing a Change Control Program

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

Phase 1: Propose the Change

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

Conclusion

Final Assessment

Certification

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

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