AZAVAI GxP Academy
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School of GMP and Pharmaceutical Quality

Pilot course — GMP fundamentals and quality system

Connect requirements to quality decisions and expected evidence.

Decision to master

Connect GMP principles to a documented quality decision in a simple operational situation.

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. Introduction to GMP principles and the quality system
  2. Fundamental regulatory requirements and frameworks
  3. Roles, responsibilities and quality culture
  4. Scenario: documented quality decision