21 CFR Part 111 · Subpart E

Production and Process Control System

The requirement to establish and follow a written production and process control system, and the specifications that system has to set. This is the spine of the regulation - almost every later subpart is a limb attached to it.

What you will be able to do

Describe the components of a production and process control system
Set component, in-process, packaging, label and finished batch specifications
Explain how a deviation is treated once a written procedure exists

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