21 CFR Part 820 / QMSR · Subpart B

Quality System Requirements

Management responsibility, the quality policy, the management review, internal quality audit and personnel. The subpart that decides whether a quality system has authority or only documentation.

What you will be able to do

Describe what management review must consider, and what it must produce
Plan an internal audit programme that meets the requirement
Identify the personnel and training evidence expected on file

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 32 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