FDA Regulations for Environmental Monitoring (EM) Program 2019

Topics

• Where Does the EM Program Fit in the Regulation?
• Applicable Regulations
• Basics of Setting a Robust and Effective EM Program
• Role of Clean Room Environmental Monitoring Program
• Relevant Material Verification Processes
• Key Considerations
• Processing a Completed Environmental Monitoring Test Media
• Steps and Content of an EM Program Testing Procedure
• Documentation and Data Management of EM Test Results
• Sample Handling and Incubation
• Retention of EM Test Results
• What is the EM Test Data Used For?
• Basics of Designing an Effective and Compliant EM Trend Reports
• Interpretation of EM Test Results
• Basics of Designing an Effective and Compliant EM Excursion
• Types; Content – Using Trend Report as a Critical Tool and Quality Metrics
• Handling Impacted Manufactured Batches
• Handling EM Excursion Investigation
• Corrective and Preventative Action (CAPA)
• Disposition of Affected Products with Failed Clean Room EM Test Results
• Relationship between CAPA and EM Test Data Excursion Investigations

Who should Attend

• Quality Assurance
• Quality Control
• Chemists, Analysts
• Microbiologists, Facilities
• Validation
• Manufacturing
• Materials Management
• Facilities
• Sterility Assurance
• Engineering
• Testing Technicians
• Compliance
• Raw Materials Manufacturers
• Environmental Testing Personnel
• Laboratories
• Clinical, Research and Development
• Regulatory Affairs
• Vendors/Suppliers
• All Levels of Management