eCFR Reference Browser

---

title: "21 CFR §820.25"

source: "https://www.ecfr.gov/current/title-21/section-820.25"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "820"

part_subject: "QUALITY SYSTEM REGULATION"

subpart_code: "B"

subpart_subject: "Quality System Requirements"

section_number: "820.25"

section_subject: "Personnel."

cfr_reference: "21 CFR 820.25"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b)Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1)As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

(2)Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

§820.25 - Personnel.