Quality Management Systems I

Quality Management Systems I



Learning outcomes

To provide future Healthcare and Life-Science professionals (e.g., pharma, biotech, fine-chemicals, biomedical products) with a good understanting about concepts and tools of Modern Quality Management Systems. Namely, GMP regulations and the most relevant international quality standards and guidances.


Seven teaching weeks, seven program topics (one per week).

  1. Quality, Quality Assurance, Quality Control, Quality Management, Ongoing Validation, Lifecycle Management, Systems-Thinking: principles & definitions
  2. Good Manufacturing Practice (GMP) and Modern Pharmaceutical Quality Management Systems (QMS): Roles and
  3. ICH, ISO & WHO: Quality and GMP Guidances.
  4. Quality Management in EU and US: Eudralex (Vol.4 Annex 15 of GMPs) & FDA Guidances
  5. Batch review and Product Quality Review
  6. Corrective Actions, Preventive Actions (CAPAs) and Root Cause Analysis
  7. Lifecycle Management and Continual Improvement.