The Lifecycle of a Change Control Program – Phase 1: Develop the Change Request
Description:
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 |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-161 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Understanding the complete life cycle of a change control is critical to the validation process. This course does a great job explaining that an in particular proposing the change.
If you are looking for a clever way to train your workforce on change control this is the course for your team.
Related courses:
Change Control: Regulations and Guidelines
Change Control and Change Management
How to Perform Supplier Qualification
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
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