1. Introduction 2. Sources of biocontamination, other forms of contamination, and risk profiling 3. GMP, regulations and standards 4. Biocontamination control 5. Application of Quality Risk Management and its application in biocontamination control 6. Introduction to cleanrooms and environmental monitoring 7. Viable monitoring methods 8.

Selection of culture media 9. Airborne particle monitoring 10. Rapid microbiological methods11. Designing an environmental monitoring programme 11. Putting an environmental monitoring plan together: A risk-based case study 12. Special Types of Environmental Monitoring 13. Cleanrooms and microbiota 14. Assessment of pharmaceutical water systems 15.

Data handling and trend analysis16. Bioburden and endotoxin assessment of pharmaceutical processing 17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations 18. Assessing and removing contamination risks from the process 19. The human factor: Training and controlling people in cleanrooms 20. Biocontamination deviation management 21. Synthesis: An anatomy of a contamination control strategy.