Difference between revisions of "CFR 21-820.25 - Personnel"
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The CFR regulations described with respect to Personnel are: | The CFR regulations described with respect to Personnel are: | ||
| − | * [[ | + | |
| − | * [[ | + | * [[CFR 21-007 - Enforcement Policy - Recalls]] |
| − | * [[ | + | * [[CFR 21-011 - Electronic Records; Electronic Signatures]] |
| − | * [[ | + | * [[CFR 21-1010 - Performance Standards for Electronics Products]] |
| − | * [[ | + | * [[CFR 21-801 - Labeling]] |
| − | * [[ | + | * [[CFR 21-803 - Medical Device Reporting]] |
| − | * [[ | + | * [[CFR 21-806 - Medical Devices; reports of corrections and removals]] |
| − | * [[ | + | * [[CFR 21-807 - Establishment Registration and Device Listing]] |
| − | * [[ | + | * [[CFR 21-814 - Premarket Approval of Medical Devices]] |
| − | * [[ | + | * [[CFR 21-820 - Quality System Regulations]] |
| − | * [[ | + | * [[CFR 21-820.20 - Management Control Flowchart]] |
| − | * [[ | + | * [[CFR 21-820.20 - Management Responsibility]] |
| − | * [[ | + | * [[CFR 21-820.20a - Quality System]] |
| − | * [[ | + | * [[CFR 21-820.20b - Organization]] |
| − | * [[ | + | * [[CFR 21-820.20c - Management review]] |
| − | * [[ | + | * [[CFR 21-820.20d - Quality Planning]] |
| − | * [[ | + | * [[CFR 21-820.20e - Quality System Procedures]] |
| − | * [[ | + | * [[CFR 21-820.25 - Personnel]] |
| − | * [[ | + | * [[CFR 21-820.25 - Personnel - General]] |
| − | * [[ | + | * [[CFR 21-820.25 - Personnel - Training]] |
| − | * [[ | + | * [[CFR 21-820.30a - General]] |
| − | * [[ | + | * [[CFR 21-820.30b - Design and development planning]] |
| − | * [[ | + | * [[CFR 21-820.30c - Design Input]] |
| − | * [[ | + | * [[CFR 21-820.30d - Design Output]] |
| − | * [[ | + | * [[CFR 21-820.30e - Design Review]] |
| − | * [[ | + | * [[CFR 21-820.30f - Design Verification]] |
| − | * [[ | + | * [[CFR 21-820.30g - Design Validation]] |
| − | * [[ | + | * [[CFR 21-820.30h - Design Transfer]] |
| − | * [[ | + | * [[CFR 21-820.30i - Design Changes]] |
| − | * [[ | + | * [[CFR 21-820.30j - Design History File]] |
| − | * [[ | + | * [[CFR 21-820.40a - Document approval and distribution]] |
| − | * [[ | + | * [[CFR 21-820.40b - Document Changes]] |
| − | * [[ | + | * [[CFR 21-821 - Medical Device Tracking Requirements]] |
| − | * [[ | + | * [[CFR 21-840 - Document Controls]] |
| − | * [[ | + | * [[CFR 21-860 - Medical Device Classification Procedures]] |
| − | * [[ | + | * [[CFR 21-861 - Procedures for Performance Standards Development]] |
| − | * [[ | + | * [[CFR 21-892 - Radiological Devices]] |
| − | * [[ | + | * [[CFR 21-895 - Banned Devices]] |
| − | * [[ | + | * [[Device Master File]] |
| + | * [[Device Master Record]] | ||
Latest revision as of 16:54, 27 August 2020
The CFR regulations described with respect to Personnel are:
- CFR 21-007 - Enforcement Policy - Recalls
- CFR 21-011 - Electronic Records; Electronic Signatures
- CFR 21-1010 - Performance Standards for Electronics Products
- CFR 21-801 - Labeling
- CFR 21-803 - Medical Device Reporting
- CFR 21-806 - Medical Devices; reports of corrections and removals
- CFR 21-807 - Establishment Registration and Device Listing
- CFR 21-814 - Premarket Approval of Medical Devices
- CFR 21-820 - Quality System Regulations
- CFR 21-820.20 - Management Control Flowchart
- CFR 21-820.20 - Management Responsibility
- CFR 21-820.20a - Quality System
- CFR 21-820.20b - Organization
- CFR 21-820.20c - Management review
- CFR 21-820.20d - Quality Planning
- CFR 21-820.20e - Quality System Procedures
- CFR 21-820.25 - Personnel
- CFR 21-820.25 - Personnel - General
- CFR 21-820.25 - Personnel - Training
- CFR 21-820.30a - General
- CFR 21-820.30b - Design and development planning
- CFR 21-820.30c - Design Input
- CFR 21-820.30d - Design Output
- CFR 21-820.30e - Design Review
- CFR 21-820.30f - Design Verification
- CFR 21-820.30g - Design Validation
- CFR 21-820.30h - Design Transfer
- CFR 21-820.30i - Design Changes
- CFR 21-820.30j - Design History File
- CFR 21-820.40a - Document approval and distribution
- CFR 21-820.40b - Document Changes
- CFR 21-821 - Medical Device Tracking Requirements
- CFR 21-840 - Document Controls
- CFR 21-860 - Medical Device Classification Procedures
- CFR 21-861 - Procedures for Performance Standards Development
- CFR 21-892 - Radiological Devices
- CFR 21-895 - Banned Devices
- Device Master File
- Device Master Record
FDA Inspection
During inspection attention points will be:
- If procedures identifying training needs exist
- Review all training records to ensure that training is documented and being conducted
- Verify if employees are made aware of defects and errors that may occur if they fail to perform their job.
- Verify that quality personnel have been made aware of defects and errors thaht may occuring during bad perfomance in their job.
