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Employee training is a critical compliance requirement
for cGMPs, QSRs, GTPs and GLPs. The cGMP
regulations require:
"§ 211.25 Personnel
qualifications.
(a) Each person engaged
in the manufacture, processing, packing, or holding of a
drug product shall have education, training, and
experience, or any combination thereof, to enable that
person to perform the assigned functions. Training
shall be in the particular operations that the employee
performs and in current good manufacturing practice
(including the current good manufacturing practice
regulations in this chapter and written procedures
required by these regulations) as they relate to the
employee’s functions. Training in current good
manufacturing practice shall be conducted by qualified
individuals on a continuing basis and with sufficient
frequency to assure that employees remain familiar with
CGMP requirements applicable to them."
The other regulations have similar requirements.
We provide our clients with
on-site training services, specifically designed for
their organizations. We also assist in the
development of a documented training system that will
meet regulatory requirements:
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Annual training
on the regulations.
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We provide required
training on the specific
21
CFR regulations that are appropriate for
each client organization.
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Generally this
training includes a PowerPoint presentation
introducing the topic of the FDA regulation
process and
presentation sections that are specific to the
regulations necessary for the client's
operations. Examples of FDA Warning
Letters and other regulatory actions are
discussed to illustrate the need for compliance.
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A electronic
training manual is provided with copies of the
slides, Warning Letters and full copies of each
21 CFR regulation covered in the presentation.
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The client may
videotape the training session to use as part of
his new employee orientation process.
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Job specific
training. |
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The regulations
require that each employee have documented
training on the written procedures (SOPs and
other documents) that are related to that
employee's job function. This training
must be completed and documented within the
employee's training file, before he performs any
action, process or procedure described under the
SOP. |
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We assist
organizations in setting up their job specific
training program and its documentation. We
also provide training for the "Trainers."
It is most appropriate for job specific SOP
training to be conducted by supervisors for each
job function in conjunction with oversight by
the quality organization.
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Except for SOP
revisions associated with minor typographical
corrections, the statement "read and understood"
is not appropriate or sufficient to document an
employee's training on a specific procedure.
Inspectors particularly question employee
training files that list training on several
SOPs on the same calendar day. These and
similar problems should be addressed by a
suitable and compliant job specific training
program. |
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Other training.
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Other (non-FDA)
training is part of the orientation program most
organizations conduct for their new employees.
Examples include safety training, sexual
harassment training, personal and corporate
responsibility training, employee benefits
training, etc. More senior employees may
receive leadership training, motivational
training, etc. These training programs are
generally the responsibility of a human
resources function. |
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We strongly suggest
that all training associated with FDA compliance
be kept strictly separate from other employee
training programs. Compliance and
regulatory associated training and its
documentation should be the responsibility of
the Quality organization.
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