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.

Curriculum for this course:
Program Introduction
Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Glossary 1 min 21 secs
Implementing a Change Control Program
Requirements for a Change Control Program (ICH Q10) 1 min 05 sec
The Four Change Control Phases 1 min 10 secs
Phase 1: Propose 1 min 05 secs
Phase 2: Evaluate 1 min 15 secs
Phase 3: Implement 1 min 07 secs
Phase 4: Review 1 min 24 secs
Phase 1: Propose the Change
Propose Phase 1 Questions 1 min 12 secs
Perform Change Control Phase 1 Step 1: Identify 1 mins 29 secs
Considerations in Developing the Change Request 1 min 21 secs
Step 1: Considerations in the Change Request – The Impact Assessment 1 min 25 secs
Writing the Change Request Part I 1 min 10 secs
Writing the Change Request Part II 1 min 09 secs
Writing the Change Request Part III 1 min 30 secs
Change Control: Examples of Minor vs Major 1 min 11 secs
End of Phase 1 1 min 14 secs
Final Assessment

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