21 CFR Part 111 · Subpart B

Personnel

Qualification, training, hygiene and supervision. Short, and disproportionately cited: an investigator who cannot find a training record for the person who signed a release has found a finding.

What you will be able to do

Identify the training and qualification evidence the rule expects on file
Apply the hygiene and clothing requirements to your own operation
Explain what adequate supervision means where the rule declines to define it

What the package includes

Full-length training video, presenter-led
Presenter script
Companion handout for the subpart
Ten-question graded assessment
Audit-ready SOPs for the subpart
Fillable records and supporting documents

Listed runtime 19 minutes. Which materials open on your account depends on the plan you hold.

Watch this module on the free trial

The three-day trial opens the first six modules of 21 CFR Part 111 on screen. No card, and nothing converts automatically.Start the 3-day trial See pricing