Course Name
Cleanroom Classification, Qualification & Validation, and Contamination Control Based on ISO 14644 Standards
Course Overview
Welcome to the Cleanroom Classification, Qualification & Validation, and Contamination Control Based on ISO 14644 Standards training course by ARG Academy. This comprehensive program is designed to provide participants with an in-depth understanding of cleanroom functions and their critical relevance in the medical and pharmaceutical industries. The course thoroughly covers the regulatory framework, including ISO 14644, ISO 13485 (clauses 6.3 & 6.4), ISO 14698, MDD/MDR, and EU-GMP Annex 1, ensuring your facility remains compliant and your products remain safe.
Course Objective
By the end of this training, participants will be equipped to:
● Understand ISO 14644-based cleanroom classifications and the surrounding regulatory context.
● Identify various sources of contamination (human, equipment, environmental) and apply effective contamination control principles.
● Perform strict cleanroom gowning techniques, hygiene practices, and behavioural protocols.
● Implement robust programs for cleanroom monitoring, cleaning schedules, documentation, and qualification.
● Assess operational risks, set up accurate alert/action limits, and manage cleanroom compliance effectively.
Course Benefits
Participating in this structured training provides practical, actionable benefits for your operations:
● Design & Layout Knowledge: Gain a clear understanding of cleanroom design requirements, including Air Handling Units (AHU), HEPA filters, and static pressure zones.
● Mastery of Classifications: Learn the mathematical correlations and particle concentration limits that define ISO Classes 1-9.
● Operational Readiness: Understand the specific steps for as-built, at-rest, and operational cleanroom qualification, alongside their strict documentation requirements.
● Bioburden Management: Learn how bioburden sources and sampling methods directly impact sterilization and process validation.
● Practical Application: Apply learned concepts directly to realistic cleanroom non-conformance scenarios through interactive group activities.
Who Must Attend
This training is essential for personnel responsible for maintaining the integrity, compliance, and operation of controlled environments:
● QA and Regulatory Personnel.
● Assembly and Production Personnel.
● Engineering and Maintenance personnel.
Methodology
The course is delivered using a multi-faceted approach to ensure high engagement and knowledge retention:
● Instructor-led Presentations: Detailed sessions covering the theoretical and regulatory aspects of cleanroom management.
● Audit Case Studies: Real-world examples highlighting issues in cleanroom qualification, validation, and routine monitoring.
● Video Demonstrations: Visual demonstrations focusing on cleanroom set-up and daily operations.
● Assessments & Competency Checks: Participant knowledge is measured through quizzes, a post-training test, and practical case analysis.
● Group Activity: An interactive Audit Simulation to test real-world problem-solving.
● Comprehensive Materials: Attendees receive PowerPoint slides, a participant manual, audit checklists, a cleanroom behaviour guide, and sample validation protocols.
Course Duration
● The training spans 2 Days.
● Sessions run for 8 hours per day, which includes designated time for breaks.
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