FDA Regulations for Environmental Monitoring (EM) Program


FDA Regulations for Environmental Monitoring (EM) Program is a webinar that covers topics such as:

  • 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

FDA Regulations for Environmental Monitoring (EM) Program is intended for:

  • 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

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