FDA Regulations for Environmental Monitoring (EM) Program

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

Joy McElroy
Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

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