About CDG’s ISO 14644 Clean Room Inspection & Validation Course

CDG is a leading provider of online training and certification for various international standards, offering flexible, self-paced learning experiences. Our ISO 14644 Clean Room Inspection & Validation course is designed to equip professionals with in-depth knowledge of clean room classification, validation, inspection techniques, and regulatory compliance.

This course is ideal for those working in industries that rely on controlled environments, such as pharmaceuticals, biotechnology, semiconductor manufacturing, aerospace, and medical devices. Participants will gain a thorough understanding of ISO 14644 standards, industry best practices, and validation methodologies essential for maintaining a contamination-free workspace.

Upon successful completion of the online exam, participants will receive a certification of completion, generated instantly through our platform.

Who Should Enroll?

This course is highly recommended for:
✔️ Clean Room Compliance Officers & Quality Assurance (QA) Professionals
✔️ Facility Engineers & Maintenance Teams (HVAC, Filtration, and Environmental Monitoring)
✔️ Pharmaceutical & Biotech Industry Personnel (Sterile Manufacturing, Aseptic Processing)
✔️ Regulatory Affairs & Auditing Professionals
✔️ Semiconductor & Electronics Industry Engineers
✔️ Aerospace, Medical Device & Nanotechnology Professionals
✔️ Anyone responsible for Clean Room Operations, Validation, and Regulatory Compliance

Whether you are new to clean room management or looking to enhance your existing knowledge, this course provides a structured learning experience with real-world applications.

What You Will Learn

The ISO 14644 Clean Room Inspection & Validation course provides a step-by-step approach to understanding:

1️⃣ Clean Room Fundamentals & Classification

• Definition and importance of clean rooms in controlled environments
• ISO 14644-1 clean room classification system (ISO Classes 1–9)
• Airborne particulate contamination control – understanding particle size and concentration limits
• Clean room design considerations and impact of contamination sources

2️⃣ Clean Room Validation & Testing

• Overview of ISO 14644-2 requirements for monitoring and compliance verification
• Validation techniques for different clean room states (as-built, at-rest, and operational)
• Particle counting methods and use of laser particle counters
• Clean room requalification procedures (6-month and 12-month testing)

3️⃣ HEPA & ULPA Filtration Systems

• HEPA (High-Efficiency Particulate Air) & ULPA (Ultra-Low Penetration Air) filters
• Filter integrity testing (aerosol challenge tests, leak testing, differential pressure monitoring)
• Air exchange rates and unidirectional vs. turbulent airflow in clean rooms

4️⃣ Clean Room Environmental Monitoring & Compliance

• Real-time airborne particle and microbial contamination monitoring
• Temperature, humidity, and pressure control in clean room environments
• Corrective action planning for environmental deviations and contamination incidents

5️⃣ Clean Room Operational Practices & Personnel Behavior

• Gowning procedures and clean room dress codes
• Material movement workflows to minimize contamination risks
• Standard Operating Procedures (SOPs) for contamination control and emergency response

6️⃣ Clean Room Inspection, Auditing & Regulatory Compliance

• Regulatory alignment with WHO GMP, FDA 21 CFR Part 211, EU GMP & USP 797
• Preparing for clean room audits and ensuring long-term ISO 14644 compliance
• Data integrity and ALCOA+ principles for record-keeping and reporting
• CAPA (Corrective and Preventive Actions) for non-compliance issues

7️⃣ Future Trends: AI, Automation & Sustainable Clean Room Operations

• AI-driven environmental monitoring and predictive contamination control
• Clean room robotics for aseptic processing and automated material transfer
• Energy-efficient clean room designs and sustainability initiatives

By the end of this course, participants will be well-versed in ISO 14644 compliance requirements, clean room validation techniques, and industry best practices for maintaining high-performance clean environments.

Course Features & Benefits

✅ Self-Paced Online Learning – Study at your convenience, anytime, anywhere
✅ Comprehensive Training Materials – Detailed explanations, case studies, and real-world examples
✅ Online Exam – Test your knowledge with a structured assessment
✅ Instant Certification – Receive a digital certificate immediately upon passing the exam
✅ Industry-Relevant Insights – Learn how ISO 14644 applies to various sectors, including pharma, biotech, semiconductors, aerospace, and medical devices
✅ Expert-Designed Curriculum – Developed by industry professionals with extensive experience in clean room compliance and validation

Exam & Certification

• The course concludes with an online examination that tests your understanding of ISO 14644 principles, validation techniques, and regulatory compliance requirements.
• The exam format includes multiple-choice questions (MCQs) to assess key concepts.
• A minimum passing score is required to earn your ISO 14644 Clean Room Inspection & Validation Certificate.
• The certificate is automatically generated online upon successful completion of the exam.

This certification demonstrates your proficiency in clean room compliance and enhances your professional credibility in industries that require strict contamination control measures.

Why Choose CDG for Your ISO 14644 Training?

🔹 Trusted Training Provider – CDG is a well-recognized name in ISO training and certification
🔹 Flexible Learning – Learn at your own pace with no deadlines or fixed schedules
🔹 Affordable & Accessible – No hidden fees, and available worldwide
🔹 Industry-Relevant Content – Course designed by professionals with real-world clean room experience
🔹 Instant Certification – No waiting time – get certified immediately after passing the exam

Whether you’re looking to start a career in clean room operations, enhance your current knowledge, or ensure compliance in your organization, this course provides everything you need to become proficient in ISO 14644 clean room inspection and validation.

Enroll Today!

Take the next step in your professional journey by enrolling in CDG’s ISO 14644 Clean Room Inspection & Validation course. Gain the knowledge, skills, and certification required to maintain world-class clean room environments in compliance with international standards.

🎓 Start learning today and earn your certification! 🚀