Pharma and life sciences companies are increasingly faced with the challenge of implementing a risk-based and robust Contamination Control Strategy (CCS). The training course for certified cleanroom experts imparts exactly the skills necessary for this: a solid regulatory foundation, practical technical understanding, and in-depth knowledge of purity-related backgrounds and contexts.

Through practical exercises, interactive workshops, as well as training and simulation sessions in the comprei training cleanroom, participants can immediately transfer what they have learned into their operational daily routine.

Your added value at a glance

Graduates will gain a comprehensive understanding of current regulatory requirements, the most important GMP guidelines, and the technical and organizational fundamentals of contamination-safe cleanroom operation. They will learn:

– to make well-founded, risk-based decisions according to modern GMP principles
– to plan, operate, and monitor cleanroom processes effectively
– to integrate hygiene and technical concepts coherently with the CCS
– to implement quality assurance measures efficiently and at the state-of-the-art level

Course structure

The course comprises three modules, each lasting three days. Between modules, participants work on an exam-relevant project to practically apply the acquired knowledge. After completing the last module, an oral final exam takes place.

Module 1: Quality Assurance

This module provides a structured understanding of the regulatory basics (including EU-GMP guidelines) and demonstrates their importance for an effective Contamination Control Strategy.

Focus areas:

– Principles of risk-based pharmaceutical quality management
– QM tools such as Change Control, CAPA, and deviation management
– Practical application in the cleanroom environment
– Audit and inspection preparation as well as typical questions

Module 2: Cleanroom Hygiene

Humans, cleanrooms, and products form central risk factors in contamination-critical processes. This module shows how hygiene requirements can be derived from a coherent CCS, implemented, and monitored.

Topics:

– GMP-compliant personnel and operational hygiene concepts
– Cleaning and disinfection strategies including active ingredient rotation
– Development of practical clothing and pass-through concepts
– Risk-based monitoring of microbial and non-microbial contamination

Module 3: Cleanroom Technology

This module imparts the technical fundamentals of modern cleanroom operation as well as the regulatory requirements of ISO 14644-1 and the EU-GMP guidelines.

Topics:

– Cleanroom classification and normative requirements for planning, construction, and qualification
– Technical interrelations in plant and process design (including V-model)
– Challenges of continuous cleanroom monitoring and correct particle measurement
– Comparison of barrier systems regarding their hygiene concepts
– Fundamentals and validation of sterilization and decontamination procedures

Next course dates

Quality Assurance (3 days)
September 30 – October 2, 2026: Kempten (Germany)
January 27-29, 2027: Vienna (Austria)

– Regulatory framework, risk-based pharmaceutical quality management, and development of application examples
– CAPA, Change Control, Deviation Management, and inspection practices

Cleanroom Hygiene (3 days)
November 11-13, 2026: Kempten (Germany)
March 3-5, 2027: Vienna (Austria)

– Focus on contamination prevention through Contamination Control Strategy (CCS)
– Backgrounds and workshops on risk-based cleaning and disinfection strategies, clothing/pass-through concepts, and environmental monitoring
– Breakout sessions in the training cleanroom

Cleanroom Technology (3 days):
December 9-11, 2026: Kempten (Germany)
April 14-16, 2027: Vienna (Austria)

– Normative requirements (ISO 14644-1, EU-GMP guidelines), classification/particle measurements, planning, construction, qualification, V-model
– Barrier systems, sterilization procedures, and validation

Event location Germany: Kempten
Event location Austria: Vienna

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