21 CFR 111.12 - What personnel qualification requirements apply?
(b) You must identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.