21 CFR Part 111 · Subpart I

Batch Production Record

The executed record of what actually happened, made against the master record, signed as it is performed. The document an investigator asks for first when tracing a specific lot.

What you will be able to do

Execute a batch record so the entries stand as contemporaneous evidence
Explain what has to be recorded at the moment it happens, and by whom
Trace a finished lot back through its batch record to its components

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 29 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