An integral part of compliance with cGMPs is the acquisition and retention of personnel with sufficient education, experience and training to do the job properly.
Training is an on-going activity intended to reinforce good working practices and to introduce changes to systems and procedures in an orderly and documented fashion. With a new facility the training programme takes on an additional dimension in that many of the employees may be new, and the systems and procedures may be untested. The initial level of effort that must be devoted to training with a new facility is generally much greater than that required to maintain the programme once the plant has been in operation for some time.
Aker Kvaerner is experienced in providing training and/or review classes for cGMP and validation programmes for utilities, systems, equipment, and processes. All training is thoroughly documented. Aker Kvaerner can also assist with the establishment of an on-going training programme.
Aker Kvaerner can also provide through the Institute of Validation and the University of Brighton a certified training in validation fundamentals. This is in alignment with the compliance requirements for training; 21 CFR Parts 211:25 and Article 7 of the 1993 EU Guide.
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