AZAVAI GxP Academy
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School of GMP and Pharmaceutical Quality

Pharmaceutical quality system according to ICH Q10

Connect requirements to quality decisions and expected evidence.

Decision to master

Position a decision within the pharmaceutical quality-system lifecycle according to ICH Q10.

Learning objectives

  • Explain the quality intent associated with "GMP".
  • Identify the risks, responsibilities and evidence expected in a professional situation.
  • Formulate a proportionate, traceable and defensible decision.

Indicative programme

  1. ICH Q10 model: pharmaceutical quality system lifecycle
  2. Change management and technology transfer
  3. Management review, metrics and continuous improvement
  4. Position a quality decision within the Q10 lifecycle

Prerequisites

  • GMP fundamentals and quality system
  • Quality risk management (ICH Q9) recommended