Supplier qualification

Decision to master

Determine supplier qualification and monitoring according to criticality.

Learning objectives

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

Indicative programme

1. Supplier classification: critical, strategic, standard
2. Supplier audit: preparation, conduct, report, follow-up
3. Quality agreements: specifications, change, notification
4. Ongoing monitoring: KPIs, requalification, action plan

Prerequisites

• GMP fundamentals and quality system
• Experience in quality assurance or qualified procurement