FDA Regulations for Environmental Monitoring (EM) Program 2017

Topics

• Basics of Setting a Robust and Effective EM Program
• Applicable Regulations
• Basics of Designing an Effective and Compliant EM Trend Reports
• Processing a Completed Environmental Monitoring Test Media
• Corrective and Preventative Action (CAPA)
• Basics of Designing an Effective and Compliant EM Excursion Program

Who should Attend

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