Biomedical Engineering Reference
In-Depth Information
Table 5.1
Illustrative training modules
Module
Overview element
SOJT element
Central Weigh Module
Material
Management
■
Storage of Raw
Materials
■
Dispensing Raw
Materials
1st Cleaning Module
Cleaning and
Sanitizing I
■
Facility Cleaning
Preparation of
Solutions and Buffers
Media and Buffer
Preparation
■
pH Measurement
■
Preparing Media
■
Preparing Buffers
2nd Cleaning Module
Cleaning and
Sanitizing II
■
CIP (Clean-in-Place)
■
SIP (Sterilize-in-Place)
training module and the associated procedure. That too will
be delineated in the Design phase.
5.2.1 How training modules relate
to SOPs
There are two ways that a training module can be related to
a procedure. The fi rst is directly, where the module trains to
the procedure; this is sometimes called “document based
training.” The second is indirectly, where the training module
is mandated in the SOP, but the module does not train to the
procedure; this is called “non-document based training.” An
example of the latter is training in current GMPs, an FDA
requirement. The FDA requires that this training be both
“current” and “conducted on a continuing basis.”
4
These
requirements are typically met by training on courseware
that is repeatedly offered, say on a quarterly basis, and is
also frequently revised to ensure currency. The SOP that
