Change Control

The Lifecycle of a Change Control Program – Phase 2: Evaluate

The process of the change control lifecycle begins with Phase 1 – Propose, in which a need for change is identified and developed, as shown in Figure 3. Once all of the information is recorded on the change request document (we covered this in detail in our course on Phase 1 of implementing a change control program), the change request is completed and submitted to a change control committee (CCC) and Quality Assurance (QA). During Phase 2 (Evaluate), the details of the CCC/QA evaluation are recorded, along with the signatures of all who participated.

CEU Credits: 0.1
Course Code: ELM-178
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning Objectives
Glossary
Phase 2/Step 2: Guidelines on Evaluation of the Change Control Request
Phase 2: Roles – Subject Matter Experts
Roles: The Change Control Committee
Roles: The Quality Unit’s Role in Evaluation
Change Control Evaluation
Documenting the Change Request Approval/Denial
Steps in Approving a Change Request
Change request Part III – Tasks, Responsibilities and Scheduling

Conclusion

Final Assessment

Certification

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

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