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Personnel Qualification and training in GxP environments

The eLearning module looks at the key principles of training and development, and the different types of training methods in GxP environments. It also reviews the various stages of training in a typical biotech or pharmaceutical organization.

  • Principles of training and development

  • The regulatory bodies’ (WHO, FDA, and EU) viewpoint on training in GMP

  • Role of training in improving competence and effectiveness of the pharmaceutical workforce

  • Five steps of training including Training Need Analysis (TNA), role based and trigger-based training

  • Training methods including classroom training, hands on training, computer based training and self learning

  • Evaluating the impact and effectiveness of training

Why it matters

Training is essential in a GXP regulated environment. Poor training can have a significant impact on performance and productivity of employees. Conversely\, good training ensures that the workforce is competent\, effective\, and adept at handling challenging situations. A competent workforce implies smoother operations with less errors; unhindered production\, clinical testing and marketing of safe drugs with minimal regulatory hurdles.

Who is it for

This module is relevant to all employees in the pharmaceutical industry.

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