21 CFR Part 820 / QMSR · Subpart J

Corrective and Preventive Action

Analysing quality data, investigating cause, taking action, verifying effectiveness and feeding results back into management review. The subpart most often at the centre of a Warning Letter.

What you will be able to do

Investigate to cause rather than to symptom
Verify that a corrective action was effective, with evidence
Explain why a CAPA system without data analysis is not a CAPA system

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 36 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 820 / QMSR on screen. No card, and nothing converts automatically.Start the 3-day trial See pricing