FDA Regulations for Environmental Monitoring (EM) Program

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

Why Should You Attend:

This 90-minute webinar will discuss various broad and critical aspects of an effective EM program such as the phases of a cleanroom EM program-pre-monitoring of a cleanroom prior to facility validation, implementation of routine EM using facility validation data and post-validation. Procedural steps, content of a robust EM program such as handling, incubation, documentation, management and trending of data, EM excursion investigation and product impact and disposition will be discussed

Learning Objectives:

Upon completion of this training, participants will be able to:

• Describe how clean room environmental monitoring program fits into the regulations
• Explain the basis of the four phases of clean room transitional monitoring (pre-qualification through post-qualification EM) and what each type stands for
• List the basic content of a well-designed, effective and compliant EM program
• Explain the relationship between an EM Excursion Program and CAPA

Areas Covered in the Webinar:

• 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

Who Will Benefit:

This webinar will provide a great resource to product manufacturers with personnel in the pharmaceutical, biotechnology, biologics, drugs, diagnostics, cell therapy, and medical device industries.

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