21 CFR Part 211 · Subpart B

Organization and Personnel

The responsibilities of the quality control unit, the qualification and training of personnel, and the consultants a firm relies on. This is the subpart an investigator uses to test whether your quality unit has real authority or only a place on the organisation chart.

What you will be able to do

Describe the authority the quality control unit must hold, and what it cannot delegate
Identify the training records an investigator expects to be handed
Recognise the organisational arrangements that routinely draw observations

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 26 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 211 on screen. No card, and nothing converts automatically.Start the 3-day trial See pricing