GMP Environmental Monitoring in Pharmaceutical Clean Rooms 2019

Topics

• Regulatory Clean Room Classification and Requirements
• GMP Compliance of Clean Room Environment
• Action and Alert Levels
• Environmental Monitoring Program
• Microbial Monitoring Systems
• Non-Viable Particulate Monitoring Systems
• Clean Room Monitoring Practices - Frequency, Locations, and Investigations
• Personnel Gowning and Aseptic Practices in Clean Room
• Environmental Monitoring Data Trend reports
• Product Release

Who should Attend

• Environmental Monitoring
• Quality Assurance
• Manufacturing
• Microbiology
• Engineering
• Validation
• Maintenance