AZAVAI GxP Academy
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School of Validation and Qualification

Cleaning validation

Connect requirements to quality decisions and expected evidence.

Decision to master

Define a cleaning-validation strategy consistent with product, process and equipment risks.

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. Validation strategy: risk-based approach, worst cases
  2. Agent selection, analytical methods, residue limits
  3. Cleaning protocols: manual, CIP, SIP, verification
  4. Maintaining validated state: revalidation, monitoring

Prerequisites

  • GMP fundamentals and quality system
  • Validation and qualification DQ/IQ/OQ/PQ (or equivalent experience)