21 CFR Part 111 · Subpart A

General Provisions

Who Part 111 binds, what a dietary supplement is for the purposes of the rule, and the definitions the remaining fifteen subparts are written in. It also settles what happens when you use a contract manufacturer, which is where most ownership arguments start.

What you will be able to do

State which operations Part 111 applies to, and where the rule stops
Use the defined terms precisely, particularly component, dietary ingredient and batch
Explain who carries the obligation when manufacturing is contracted out

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 24 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