21 CFR Part 111 · Subpart O

Product Complaints

Receiving, reviewing and investigating complaints, and the link between a complaint and a serious adverse event report. Complaints are an early warning system the rule requires you to operate.

What you will be able to do

Run a complaint through review and investigation as the rule requires
Recognise the complaint that must be escalated rather than closed
Explain the qualified-person requirement for complaint review

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 23 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