The Certification Program Cleanroom Expert provides professionals with the practical, regulatory and technical competencies required for safe, compliant and risk‑based cleanroom operations. The course focuses on the effective implementation of a Contamination Control Strategy (CCS) as well as the technical and organizational elements essential for modern cleanroom environments in the pharmaceutical and life science industries.
Through workshops, case studies and hands‑on exercises in the comprei Training Cleanroom, participants gain immediately applicable knowledge in cleanroom hygiene, cleanroom technology and pharmaceutical quality assurance.
• Practical, industry‑relevant qualification aligned with current EU‑GMP and ISO requirements
• Strong emphasis on risk‑based thinking and CCS‑aligned decision‑making
• High practical relevance through exercises, group work and live cleanroom sessions
• Suitable for pharmaceutical, biotech, medical device and high‑tech manufacturing environments
1. Quality Assurance
• Regulatory foundations (EU‑GMP, ISO standards)
• Risk‑based pharmaceutical quality management
• Change Control, CAPA and Deviation Management
• Preparation, execution and follow‑up of audits and inspections
2. Cleanroom Hygiene
• Deriving and implementing a robust Contamination Control Strategy
• Personnel behavior and qualification in the cleanroom
• Cleaning and disinfection strategies including agent rotation
• Gowning concepts and personnel/material flow
• Risk‑based environmental monitoring (microbial and particulate)
• Hands‑on exercises in the training cleanroom
3. Cleanroom Technology
• Planning, construction and qualification according to ISO 14644‑1 and EU‑GMP
• Technical principles, airflow concepts and system interactions (including V‑Model)
• Routine cleanroom monitoring and particle measurement
• Comparison and evaluation of barrier systems (RABS/Isolators)
• Fundamentals and validation of sterilization and decontamination processes
Graduates are equipped to implement cleanroom requirements safely, efficiently and in compliance with current standards, contributing to stable manufacturing processes, regulatory compliance and long‑term quality improvement.
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