Hello,

I am looking for tips on how other sites are implementing or are practicing the demonstrated competency for personnel training in USP 800.

Who at your site is responsible for developing or managing the demonstrated competency for each department?

9. PERSONNEL TRAINING
All personnel who handle HDs must be trained based on their job functions (e.g., in the receipt, storage, compounding,
repackaging, dispensing, administrating, and disposing of HDs). Training must occur before the employee independently handles HDs. The effectiveness of training for HD handling competencies must be demonstrated by each employee. Personnel
competency must be reassessed at least every 12 months. Personnel must be trained prior to the introduction of a new HD or new equipment and prior to a new or significant change in process or SOP. All training and competency assessment must be documented.
The training must include at least the following:
• Overview of entity's list of HDs and their risks
• Review of the entity's SOPs related to handling of HDs
• Proper use of PPE
• Proper use of equipment and devices (e.g., engineering controls)
• Response to known or suspected HD exposure
• Spill management
• Proper disposal of HDs and trace-contaminated materials

Thanks in advance for your advice!