Interested participants from other time zones are welcome to contact us regarding the training at [email protected].
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Cleanrooms are critical to maintaining product safety, quality and compliance in highly regulated industries such as medical devices. In the context of Regulation (EU) 2017/745 maintaining a compliant cleanroom environment is essential for manufacturers of medical devices. Cleanrooms play a crucial role in ensuring that products are manufactured under controlled conditions, free from contamination, and in line with quality and safety requirements mandated by EU regulations and international standards.
This training session provides a comprehensive overview of cleanroom requirements, focusing on both regulatory expectations and operational excellence. Participants will gain practical knowledge of cleanroom classifications, behavior protocols, environmental monitoring, and contamination control strategies, aligned with international standards such as ISO 14644, and EU GMP Annex 1 and relevant requirements under (EU) MDR.
Whether you are new to cleanroom operations or seeking to reinforce best practices within your team, this session will equip you with the tools and insights to ensure cleanroom integrity and maintain ongoing compliance.
Key Topics Covered
- Cleanroom classification and design (ISO 14644, EU GMP Annex 1)
- Principles of contamination control: sources, types, and mitigation
- Cleanroom entry, gowning, and behavior protocols
- Environmental monitoring and cleaning procedures
- Cleanroom maintenance and HVAC control
- Regulatory requirements for cleanroom environments in medical device industries
- Common compliance issues and how to avoid them
- Training, documentation and audit readiness
Key Benefits
Participants will:
- Understand the regulatory framework for cleanroom operations
- Learn how to identify and control contamination risks
- Gain confidence in applying gowning, hygiene, and behavior protocols
- Be able to support environmental monitoring programs and cleaning validation
- Strengthen overall compliance and inspection readiness
Target Audience: Cleanroom operators and technicians, Quality Assurance Managers, Production and Manufacturing staff, Regulatory Affairs and Validation personnel, Facility and Environmental Monitoring teams as well as anyone working in or supporting controlled environments in regulated industries
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment of medical devices.
Auditors
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Klaus Lindenberg
Auditor
Klaus Linderberg graduated from Fachhochschule Lübeck as Diplom Ingenieur (FH) in Biomedical Technology. With extensive experience across various companies in Germany’s medical device sector, he has built a strong foundation in quality and regulatory compliance. He has been working as a Lead Auditor and Technical Expert for medical device Quality Management, specializing in regulatory standards and audits. His professional background is supported by certifications relevant to medical device quality assurance and auditing.