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Mastering ISO 14644; A Step-by-Step Guide to Implementing and Auditing Standard Cleanroom Environments

Mastering ISO 14644; A Step-by-Step Guide to Implementing and Auditing Standard Cleanroom Environments

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Mastering ISO 14644: A Step-by-Step Guide to Implementing and Auditing Standard Cleanroom Environments



Course Overview

This comprehensive course provides a step-by-step guide to implementing and auditing standard cleanroom environments in accordance with ISO 14644. Participants will gain a thorough understanding of the standard, its requirements, and how to apply it in real-world scenarios. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and engaging learning experience
  • Comprehensive and up-to-date content
  • Personalized learning with expert instructors
  • Practical, real-world applications and case studies
  • High-quality content and hands-on projects
  • Certificate issued by The Art of Service upon completion
  • Flexible learning with lifetime access
  • User-friendly and mobile-accessible platform
  • Community-driven with discussion forums and live webinars
  • Actionable insights and progress tracking
  • Gamification and bite-sized lessons


Course Outline

Module 1: Introduction to ISO 14644

  • Overview of ISO 14644 and its importance
  • History and development of the standard
  • Key principles and concepts
  • Benefits of implementing ISO 14644

Module 2: Cleanroom Design and Construction

  • Design and construction requirements
  • Air filtration and ventilation systems
  • Temperature and humidity control
  • Lighting and electrical systems
  • Material selection and finishes

Module 3: Cleanroom Operations and Maintenance

  • Operational requirements and procedures
  • Cleaning and disinfection protocols
  • Personal protective equipment (PPE) and gowning
  • Training and personnel requirements
  • Maintenance and repair procedures

Module 4: Cleanroom Monitoring and Control

  • Monitoring and control requirements
  • Particle counting and air sampling
  • Microbial monitoring and control
  • Temperature and humidity monitoring
  • Alarm systems and emergency procedures

Module 5: Cleanroom Validation and Verification

  • Validation and verification requirements
  • Protocol development and execution
  • Sampling and testing methods
  • Data analysis and interpretation
  • Validation and verification reports

Module 6: Auditing and Compliance

  • Auditing requirements and procedures
  • Compliance with ISO 14644
  • Audit tools and techniques
  • Audit reporting and follow-up
  • Continuous improvement and corrective action

Module 7: Cleanroom Documentation and Record-Keeping

  • Documentation requirements and procedures
  • Record-keeping and data management
  • Document control and revision
  • Record retention and disposal
  • Electronic documentation and record-keeping systems

Module 8: Cleanroom Training and Awareness

  • Training requirements and procedures
  • Awareness and education programs
  • Training evaluation and assessment
  • Training records and documentation
  • Continuous training and professional development

Module 9: Cleanroom Risk Management

  • Risk management principles and concepts
  • Risk assessment and analysis
  • Risk mitigation and control
  • Risk monitoring and review
  • Risk management documentation and records

Module 10: Cleanroom Continuous Improvement

  • Continuous improvement principles and concepts
  • Quality management and improvement
  • Process improvement and optimization
  • Corrective and preventive action
  • Continuous improvement documentation and records


Certificate and Continuing Education

Upon completion of the course, participants will receive a certificate issued by The Art of Service. The certificate is valid for 3 years and can be renewed by completing continuing education requirements.



Target Audience

This course is designed for professionals working in cleanroom environments, including:

  • Cleanroom managers and supervisors
  • Quality control and quality assurance personnel
  • Regulatory affairs and compliance personnel
  • Engineering and maintenance personnel
  • Training and development personnel


Prerequisites

There are no prerequisites for this course. However, participants are expected to have a basic understanding of cleanroom principles and concepts.

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