AZAVAI GxP Academy
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School of Investigations and CAPA

Deviations, OOS and CAPA

Connect requirements to quality decisions and expected evidence.

Decision to master

Classify a deviation, guide the investigation and decide on CAPA based on cause and risk.

Learning objectives

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

Indicative programme

  1. Deviation classification: minor, major, critical
  2. OOS investigation: laboratory phase and production phase
  3. Root cause analysis: 5M, fault tree, 5 Whys
  4. CAPA: effectiveness, verification, closure and prevention

Prerequisites

  • GMP fundamentals and quality system
  • Basic knowledge of quality risk management (ICH Q9)