A GMP training employees program should be a direct effort, starting at the top of the organization. It may be effective to establish a training task force or an individual supported by management to coordinate training and be responsible for its delivery.
Employees:
All employees
and contractors are responsible.
- Know your
training requirements.
–
Participate actively in training and evaluations and let the trainer know if
you don't understand the material.
- Sign a
training record stating that you believe you are competent to perform the task
for which you were trained or (if the training is knowledge training) that you
understand what you were trained on.
– Discuss
your personal training and development needs with your supervisor or manager
first. Employees can obtain initial information from Human Resources.
– Implement
agreed development plans.
- Save a
copy of your training materials to your workspace, a folder provided by your
training system administrator.
Quality Assurance Manager:
The QA
manager is typically responsible for approving the design and implementation of
training systems in collaboration with the human resources department. This
role is responsible for ensuring:
- That the
training system complies with his GxP.
– System reports
meet company KPI requirements.
– Training
systems are reviewed annually.
– Approve
GMP/GLP training plans and training plans for each role.
WH&S
Manager or Specialist proposes and implements safety and environmental training
programs that meet WH&S and environmental compliance requirements
established by local governments. The team maintains records of all safety and
environmental training.
Department Heads and Supervisors:
Department
Heads and Supervisors are responsible for:
- Employees
are trained in the work of their role within an agreed period of time. This
includes training employees in temporary positions.
– New
employees and contractors complete their GMP induction training within their
first week of employment.
–
Contractors complete induction and other training related to their role in a
timely manner.
– Training
requirements for each role are identified, documented, approved, and kept up to
date.
– A plan is
in place to ensure that training and development requirements for each employee
(and contractor, if applicable) are met in a timely manner.
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