Biomedical Engineering Reference
In-Depth Information
Rather, it should be presented in smaller more manageable
sessions held throughout the year, or at a minimum be held
once a year.”
35
Speaking at an FDA workshop, compliance
offi cer Duane Sylvia suggested that, “cGMP training should
be revisited at frequent intervals and needs to be conducted
by qualifi ed individuals.” He continued, “Conducting cGMP
training once a year is not recommended, but instead should
be presented in smaller more manageable portions, presented
throughout the year with documentation of the type, time,
and attendance of each session.”
36
Some regulated organizations have developed very
elaborate schemes to schedule continuing cGMP training.
One example will suffi ce. An organization required each
employee to attend day-long refresher training at a specifi ed
location on the fi rst Monday of the employee's birth month.
There was one makeup day a year for employees who missed
their scheduled date. The training agenda was fi xed for the
entire year, regardless of intervening events. It incorporated
OSHA, cGMP, business ethics, and other refresher training,
as well as a “Meet the CEO” session. Given the packed
agenda, less than an hour was devoted to cGMP topics.
Birthday cake was provided to each attendee. Nonetheless,
this scheme was simply a variant of the “one hour, once a
year” cGMP training schedule.
Regarding industry practices, James Vesper has stated that
“most companies conduct formal GMP training or
reinforcement training at least annually; some do it twice a
year; a few do it quarterly.”
37
There are business considerations
as well as regulatory issues here. More generally, John
McConnell has indicated “How often the training course is
to be conducted depends on several factors, including:
■
employee availability;
■
total number of current employees to be trained;
