2019 - FDA Regulations for Environmental Monitoring (EM) Program

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