FDA Regulations for Environmental Monitoring (EM) Program 2019 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 2019 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
