Risk-Based Environmental Monitoring (EM) Program 2019

Risk-Based Environmental Monitoring (EM) Program 2019 is an event dedicated to environmental Monitoring (EM) programs for pharmaceutical manufacturing.

Topics

• First lesson learned – describe the different approaches to establishing initial EM sites (Performance Qualification) to ensure sufficient baseline data exist to support cleaning program effectiveness
• Incorporate Risk Mitigation steps to show how the Risks are mitigated
• The RPN approach is great
• Geometrical coverage
• Sort the scores to identify what locations are most important
• Cover all areas of the room using equation to determine sampling sites based on room square footage

Who should Attend

• Quality Assurance Departments
• Research and Development Departments
• Quality Control Departments
• Engineering Departments
• Manufacturing Departments
• Production Departments
• Operations Departments
• Microbiologists
• Validation Departments
• Everyone concerned with environmental monitoring for contamination control and sterility