21 CFR Part 211 · Subpart I

Laboratory Controls

Specifications and test procedures, testing and release for distribution, stability testing, special testing requirements, reserve samples and laboratory records. Includes the handling of out-of-specification results.

What you will be able to do

Explain the release testing that must precede distribution of a batch
Run an out-of-specification investigation that stands up under review
State the reserve sample obligations and the consequence of not holding one

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 33 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