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Apr 20, 2024
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MEDDV 103 - Change Control Documentation
3.0 Credits
Covers change control activities and procedures that apply to design of medical devices and components within; labeling/packaging; device manufacturing processes/materials; production equipment; associated documentation procedures.
Course-level Learning Objectives (CLOs)
Upon successful completion of this course, students will be able to:
- Describe how the change control procedures are organized.
- Discuss and describe the subparts and overview information of specific elements of the Quality System Regulations related to change control procedures.
- Examine change control document records and describe their relationship to other appropriate documents, activities and implementation of the design and output procedures.
- Explain how changes are communicated to all affected parties such as production, purchasing, contractors and suppliers.
- Outline the documentation and activities required for changes involving installation, servicing and / or field remedial actions or rework of warehouse stock.
- Maintain the device history record data to show that the device is manufactured in accordance with the updated device master record.
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