---
kind: "section"
citation: "21 C.F.R. § 1.503"
title: "21"
number: "1.503"
heading: "Who must develop my FSVP and perform FSVP activities?"
url: "https://uscodex.org/cfr/21/1.503"
---

# §1.503. Who must develop my FSVP and perform FSVP activities?

- (a) **Qualified individual.** A qualified individual must develop your FSVP and perform each of the activities required under this subpart. A qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an activity.
- (b) **Qualified auditor.** A qualified auditor must conduct any audit conducted in accordance with [§ 1.506(e)(1)(i)](/cfr/21/1.506.md?p=e-1-i) or [§ 1.511(c)(5)(i)(A)](/cfr/21/1.511.md?p=c-5-i-A). A qualified auditor must have technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function.

## Notes

### Source

Source: 80 FR 74340, Nov. 27, 2015, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.