Training Hub

Personnel training is not a peripheral concern in pharmaceutical compounding — it is a fundamental regulatory requirement. Every person who performs or directly supervises sterile compounding must be trained and qualified before working in a cleanroom environment, and that training must be documented, refreshed on a defined schedule, and demonstrable on demand during an inspection. The Clarix Training module provides the tools to build training plans, assign them to staff, track completion, and produce the matrix view that FDA investigators and accreditation bodies expect to see.

Navigate to Training in the left sidebar to open the Training Hub.

The training hub dashboard

The Training Hub landing page gives you an immediate view of the training status of your entire workforce:

• Overdue Training Count — the number of training assignments whose due date has passed without a completed record. Any value greater than zero warrants immediate follow-up. Overdue training for personnel currently compounding is a serious compliance finding.
• Expiring Soon — the number of assignments whose validity period ends within the next 30 days, meaning retraining will be required soon. Proactively scheduling refresher training before expiration prevents gaps in qualification.
• Recent Completions — a feed of the most recent training completions across all staff, showing who completed what and when. This helps supervisors confirm that scheduled training is being completed.

Click any summary card to navigate directly to the relevant filtered view of training records.

Regulatory basis for training requirements

21 CFR Part 211.68 (for conventional pharmaceutical manufacturers) and USP 797 (which applies specifically to sterile compounding) both establish explicit training requirements:

• Under USP 797, every person who compounds, supervises compounding, or releases CSPs (compounded sterile preparations) must complete initial training before beginning work, and then complete competency assessments — including gloved fingertip sampling and media fill testing — at defined intervals (semi-annually for Category 2 CSPs).
• Personnel must be trained in aseptic technique, gowning procedures, hand hygiene, equipment operation, and the specific SOPs applicable to their role.
• Training records must be maintained and demonstrate that training was provided by a qualified trainer, that the trainee demonstrated competency, and that training is current at all times.

FDA 483 observations related to personnel training typically cite: no documented initial training records, training records that cannot be produced for all current staff, training that has lapsed without retraining, and no verification that personnel understood training content.

The three components of the training system

The Clarix Training module is organized around three interconnected components:

1. Training Plans — define the content of a training curriculum: what materials must be reviewed, how long the qualification is valid, and who it applies to. Think of a training plan as a course syllabus.

2. Training Records (Assignments) — the individual record for a specific person being assigned to a specific plan. The assignment tracks due date, completion date, and the signed attestation that the trainee completed all required materials.

3. Personnel Training Matrix — a grid view showing every staff member's current completion status for every training plan assigned to them. This is the view that inspectors typically request during a review of your training program.

These three components work together to give both training coordinators and QA staff a complete, current picture of workforce qualification.

Role required: All staff can view their own training assignments and complete training records. Training Managers and Admins can create training plans, assign plans to staff, and view all records. QA Managers and Admins can export the training matrix.

Related pages

• Training Plans
• Records and Completion
• Personnel Training Matrix
• 483 Readiness Report
• Training Compliance Report