AZAVAI GxP Academy
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School of Validation and Qualification

Validation and qualification in GxP — DQ, IQ, OQ and PQ

Connect requirements to quality decisions and expected evidence.

Decision to master

Select and connect the DQ, IQ, OQ and PQ evidence required for controlled use.

Learning objectives

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

Indicative programme

  1. V-model and DQ / IQ / OQ / PQ articulation
  2. DQ: design, specifications and risk analysis
  3. IQ/OQ: installation, operational qualification, testing
  4. PQ: performance qualification, PPQ, release

Prerequisites

  • GMP fundamentals and quality system
  • Experience in manufacturing or validation environment