Charisma

#	Content
1	Module 1: Introduction to Environmental Monitoring
2	Module 2: Regulatory Requirements
3	Module 3: Cleanroom Classification and Controlled
4	Module 4: Viable Environmental Monitoring
5	Module 5: Non-Viable Environmental Monitoring
6	Module 6: Utility and Environmental Systems Monitoring
7	Module 7: Environmental Monitoring Program Design
8	Module 8: Data Analysis and Trending
9	Module 9: Documentation and Record Keeping
10	Module 10: Investigation and Continuous Improvement
11	Module 11: Inspection Readiness
12	Module 12: Practical Workshops and Case Studies

#	Outcomes
	• Explain the purpose and importance of environmental monitoring in GMP-regulated facilities.
	• Identify critical environmental parameters that require routine monitoring.
	• Select appropriate environmental monitoring methods and sampling locations.
	• Conduct viable and non-viable environmental monitoring activities.
	• Interpret environmental monitoring results against established limits.
	• Perform trend analysis and identify adverse environmental changes.
	• Investigate out-of-limit environmental monitoring results.
	• Document environmental monitoring activities accurately and completely.
	• Evaluate the effectiveness of contamination control measures.
	• Demonstrate inspection readiness for environmental monitoring programs.

#	Participants
1	� • Quality Assurance (QA) personnel
2	� • Quality Control (QC) Analysts
3	� • Microbiology Laboratory personnel
4	� • Environmental Monitoring Technicians
5	� • Production Operators and Supervisors
6	� • Validation and Qualification Specialists
7	� • Manufacturing Engineers
8	� • Engineering and Maintenance personnel
9	� • Cleanroom Managers
10	� • Sterile Manufacturing personnel
11	� • Regulatory Affairs professionals
12	� • Internal Auditors
13	� • Pharmaceutical, Biotechnology, Medical Device, Healthcare, Cosmetics, Food, and Chemical industry professionals
14	� • Anyone responsible for contamination control, cleanroom operations, or environmental monitoring