21 CFR Part 211 · Subpart J

Records and Reports

Equipment cleaning and use logs, component records, master and batch production records, laboratory records, distribution records, complaint files and the annual product review. What an investigator reads when the plant tour is over.

What you will be able to do

Assemble a batch production record that traces cleanly to its master record
Handle a complaint file so that a reportable event is recognised in time
Explain the retention periods the subpart imposes and where they start

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 30 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