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21 CFR Part 820 / QMSR · Subpart G

Production and Process Controls

Process control procedures, monitoring, process validation, contamination control, buildings, equipment and environmental control. Where the device stops being a design and starts being a product.

What you will be able to do

  • Determine which processes require validation rather than verification
  • Set process parameters and the monitoring that proves they held
  • Apply contamination and environmental controls to your own operation

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 38 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 trialSee pricing