Qualified auditor means a person who is a qualified individual as defined in this part and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function as required by 117.180(2). Examples of potential qualified auditors include:
(1) A government employee, including a foreign government employee; and
(2) An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter.
21 CFR § 117.3
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply: