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It is a requirement of current
Good Manufacturing Practice (cGMP) that staff are provided with not only the
appropriate technical training to enable them to perform their role correctly,
but also training in the theory and practice of GMP. Moreover both volume 4 of
the EU Guide to Good Manufacturing Practice and part 211.25(a) of title 21 of
the Code of Federal Regulations explicitly state that training must be provided
on an ongoing basis and regularly assessed.
Development and Delivery
HPCS, through their long,
practical involvement with the pharmaceutical industry are able to develop and
deliver appropriate training packages which will satisfy this basic GMP
requirement.
Our network of experts
encompasses many disciplines (scientists, engineers, validation, auditing,
laboratory and regulatory staff) which enables us to develop and deliver
tailored packages to meet the client’s training requirements for all levels of
the organisation.
HPCS training courses range
from publicly-available, hotel-based courses covering a range of technical and
cGMP subjects to “in-house” training packages tailored specifically to the
client’s requirements which can be delivered either at the client’s premises or
other available facilities.
Training Requirements Matrix
HPCS can assist with the
development and definition of training requirements matrices ranging from
technical training to broader pharmaceutical training including:
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current Good Manufacturing
Practices (cGMP)
-
Good
Quality Control Laboratory Practices
(GQCLP)
-
Good Engineering Practices
(GEP)
-
Good Distribution
Practices
-
Method
Validation
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Self-Inspections
and Auditing
-
Stability Testing
Competency Assessment
Competency assessments are
included with HPCS training packages and a number of operator-level courses are
offered with accreditation from external educational agencies. This approach
allows staff to acquire evidence of ongoing professional development with a
flexible, “matrix approach” to learning, which can lead if desired to an
industry-recognised qualification.
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