CFR section
21 CFR 820.25(b): Personnel
PART 820-QUALITY SYSTEM REGULATION · Subpart B-Quality System Requirements
Key facts
| Citation | 21 CFR 820.25(b) |
|---|---|
| Section | Personnel |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart B-Quality System Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.