Environmental Monitoring Program Overview

• Introduction to environmental monitoring (EM) and Annex 1 requirements.
• Understanding microflora and contamination sources.
• Understanding the status of different areas and the importance of trend analysis.
• Case studies in EM and effective investigations.
• Risk-based approach to setting environmental monitoring locations.
• Assessment of contamination sources and sample types.
• Importance of selecting meaningful locations.
• Effective use of HACCP methodology.
• Group exercise on analyzing a pharmaceutical process area to select appropriate environmental monitoring locations.
• Contamination control strategy panel discussion on how to use environmental monitoring to manage contamination risks.

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