Biomedical Engineering Reference
In-Depth Information
includes an SDA), and fi nally up to the qualifi cation of
SMEs was presented. Specifi c groups emphasized in this
discussion include employee qualifi cation and SME
qualifi cation. Next addressed were specifi c employee
qualifi cation considerations, including employee qualifi cation
as process, qualifi cation status, and measures to demonstrate
qualifi cation. Qualifi cation may be demonstrated by use of a
skills demonstration assessment checklist.
We then focused on the rationale for qualifi cation;
highlighting the role the qualifi cation process plays in
deviation investigations and RCA. Employee qualifi cation
proves to be a relatively expensive kind of training compared
to training
per se
. How does management decide which
procedures require employee qualifi cation, and which require
only training
per se
? We discussed 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
delineated two other aspects of the qualifi cation process,
employee disqualifi cation and employee requalifi cation.
8.8 Notes
1. See 21CFR58.29(a), Personnel.
2. See John Levchuk (1990), now available as
Training for
GMPs
(1991); also Vasilios Frankos (2007).
3. See FDA (2006)
Quality Systems Approach to
Pharmaceutical Current Good Manufacturing Practice
Regulations
. For other instances, see the following FDA
Guidance for Industry (2003):
Current Good
Manufacturing Practice for Medical Gases
; and FDA
(2004)
Sterile Drug Products Produced by Aseptic
Processing - Current Good Manufacturing Practice
.
