CFR 21-820.25 - Personnel - 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 part of their job functions.

Attention Points

There should be written procedures for:

• Identifying training needs
• Ensuring that all personnel are adequately trained to perform their assigned responsibilities
• Document the required training

Training efforts should concentrate on:

• Making employees aware of the quality system regulations
• Relating job functions to the manufacturers quality system
• Ensuring that employees are aware of device defects that may occur from the improper performance in their jobs
• Ensuring that employees with verification or validation fucntions are aware of defects and error that may be encounteed during the performance of their jobs.

Personnel will be expected to know the quality policy to exist and where it is located. TIPS:

• Send out links to the quality procedures before audits
• Have employees auditted on the locations of procedures electronically