AZAVAI GxP Academy
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School of AI and Digital Quality

Responsible artificial intelligence in regulated pharmaceutical environments

Connect requirements to quality decisions and expected evidence.

Decision to master

Assess an AI use case and decide which controls are required in a regulated pharmaceutical environment.

Learning objectives

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

Indicative programme

  1. Emerging regulatory framework: AI Act, FDA/EMA guides, GAMP 5
  2. AI risk classification: patient, product, data impact
  3. Controls: model validation, drift, explainability, data
  4. Governance: lifecycle, post-deployment monitoring, audit

Prerequisites

  • GMP fundamentals and quality system
  • Awareness of digital and data challenges (recommended)