Biomedical Engineering Reference
In-Depth Information
8.1 Introduction
This chapter discusses qualifi cation of specifi c categories of
employees in a GXP environment. Employee categories
addressed include production operators and technical subject
matter experts (SMEs). These personnel are designated for
specifi c critical tasks in an organization. Concepts discussed
herein are also applicable to laboratory analysts. This chapter
is the third illustration of the development of training content,
following the previous discussions of new employee orientation
programs, associated GXP training, and continuing current
good manufacturing practices (cGMP) training programs.
The fi rst part of this chapter discusses types of employee
training, including awareness training, training
per se
(which includes a paper-and-pencil assessment), employee
qualifi cation (i.e., training that includes a skill demonstration),
and qualifi cation of SMEs. The second part addresses types of
qualifi cation, including employee qualifi cation as process and
as status, as well as the use of SDAs in employee qualifi cation.
The third part focuses on the rationale for qualifi cation,
highlighting the role the qualifi cation process plays in
deviation investigations and root cause analyses (RCAs).
This part also considers the criteria for deciding what kind of
training is appropriate for a specifi c procedure; this depends
on the complexity and criticality of the procedure and the
associated process. The fi nal part delineates two other aspects
of the qualifi cation process, employee disqualifi cation and
employee requalifi cation.
8.2 Regulatory basis for training
FDA requires employees in all regulated areas to be trained.
For example, 21 CFR 58.29 states: “Each individual engaged
