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FDA Regulations for Environmental Monitoring (EM) Program

Duration : 60 Minutes

Joy L. McElroy,

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more

Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations. Explain the basis of the Four (4) 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.

Course Objectives:

The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for Cleaning Validations of your manufacturing equipment?

Course Outline:

•  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 Program
- Types; Content
- 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

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

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
• Microbiologist, Facilities
• Chemist, Analysts
• Manufacturing
• Validation
• Engineering
• Sterility Assurance
• Compliance
• Testing Technicians
• Environmental Testing Personnel
• Raw Materials Manufacturers
• Clinical, Research and Development
• Laboratories

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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Subject : FDA Regulations for Environmental Monitoring (EM) Program

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