[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.25]

[Page 142]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
                 Subpart B--Quality System Requirements
 
Sec. 820.25  Personnel.

    (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.