GMP audits and inspection readiness

Decision to master

Prepare and defend evidence of a controlled system during a GMP audit or inspection.

Learning objectives

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

Indicative programme

1. Types of audits and inspections: internal, supplier, authority
2. Evidence preparation: records, KPIs, CAPA, reviews
3. Inspection conduct: responses, commitments, follow-up
4. Simulation: defend a quality system before an inspector

Prerequisites

• GMP fundamentals and quality system
• Experience in quality assurance or internal audit