21 CFR Part 211 · Subpart F

Production and Process Controls

Written procedures and deviations, charge-in of components, yield calculations, in-process sampling and testing, and time limitations on production. The heart of the regulation, and where a deviation either becomes a documented decision or an observation.

What you will be able to do

Apply the requirements for written production and process control procedures
Handle a deviation so that the record supports the decision that was made
Explain how yield limits and in-process controls are expected to interact

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 34 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