21 CFR Part 820 / QMSR · Subpart C

Design Controls

Design and development planning, inputs, outputs, review, verification, validation, transfer, changes and the design history file. The most cited subpart in the regulation, and the one that decides whether a device was designed or merely built.

What you will be able to do

Distinguish design verification from design validation in practice
Assemble a design history file that tells the whole story
Control a design change without breaking traceability

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 41 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