Biocontamination Course
This course equips you with essential skills to manage biocontamination in cleanrooms using ISO 14644 and EU GMP Annex 1 standards. You will learn to design effective environmental monitoring programs, perform microbial trend analysis, conduct root cause investigations, and implement CAPA strategies. These tools help create safer, compliant cleanroom environments and significantly lower microbial risks in vital operations.

from 4 to 360h flexible workload
certificate valid in your country
What will I learn?
Gain hands-on expertise in biocontamination control for cleanrooms, covering ISO 14644 classifications, EU GMP Annex 1 guidelines, airflow dynamics, filtration systems, and pressure management. Master environmental monitoring techniques, microbial data trending, and root cause analysis methods. Enhance protocols for cleaning, gowning, HVAC operations, and material transfer while building strong EM programs, CAPA processes, and verification strategies for consistent compliance and reliability.
Elevify advantages
Develop skills
- Master cleanroom standards by applying ISO 14644 and EU GMP Annex 1 effectively.
- Design environmental monitoring programs for ISO 5-7 areas using intelligent sampling methods.
- Analyse microbial trends from EM data, set alert limits, and identify risks quickly.
- Conduct root cause investigations with on-site checks, data mapping, and robust CAPA actions.
- Optimise contamination control through better cleaning, gowning, HVAC, and material handling.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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