ISO 14644 A Complete Guide
You're not alone if you've ever felt overwhelmed trying to interpret and implement ISO 14644 standards in a high-stakes environment where error tolerance is zero. Cleanrooms are mission-critical. One misstep in classification, monitoring, or compliance can trigger costly delays, regulatory pushback, or even product recalls. The pressure is real. You're expected to deliver flawless air cleanliness validation, maintain contamination control protocols, and prove compliance-often without formal training or a reliable framework. The cost of getting it wrong? Millions in lost production, failed audits, or worse, compromised patient safety in pharma or biotech settings. But what if you could transform that uncertainty into total confidence? What if you had a step-by-step system that turns ISO 14644 from a complex regulatory hurdle into a strategic advantage-something your organisation trusts and your leadership relies on? ISO 14644 A Complete Guide is not just another technical overview. It's the only structured, expert-led programme designed to take you from confusion to competence in under 30 days-equipping you to design, validate, and maintain compliant cleanroom environments with precision, using globally accepted methodologies. One senior contamination control specialist, working in a sterile pharmaceutical manufacturing facility in Switzerland, used this system to lead her team through a successful EU Annex 1 transition, reducing non-conformances by 73% and cutting audit preparation time in half. She had no prior formal training in ISO 14644 implementation-and now she's the go-to internal expert. You don't need years of experience. You need the right framework. And one quality system that aligns with regulatory expectations, operational reality, and scientific rigor. Here's how this course is structured to help you get there.Course Format & Delivery Details Fully Self-Paced with Immediate Online Access
This course is self-paced, allowing you to learn at your own speed, on your schedule. There are no fixed start dates, no live sessions, and no time commitments. You progress when it fits-during downtime, after shifts, or between audits. TYPICAL COMPLETION TIME: 20–30 HOURS
Most professionals complete the full programme within 3–5 weeks while working full-time. Many report implementing key protocols-such as airborne particle monitoring plans or ISO classification reports-within the first 72 hours of starting. Lifetime Access & Future Updates Included
Once enrolled, you receive lifetime access to all course materials. Any future updates to reflect changes in ISO 14644 standards or regulatory guidance are delivered automatically and at no additional cost. This is a one-time investment in a living, evolving resource. Accessible Anywhere, Anytime, on Any Device
- 24/7 global access from desktop, tablet, or mobile device
- Downloadable resources for offline reference during cleanroom operations
- Fully responsive layout-readable in bright production environments or on the go
Expert-Led Support & Guidance
You're not learning in isolation. The course includes direct access to a dedicated support channel staffed by certified cleanroom consultants with over 15 years of ISO 14644 implementation experience across semiconductor, aerospace, and regulated pharmaceutical sectors. Ask questions, clarify procedures, and validate your protocols with real experts-no forum guessing. Certificate of Completion Issued by The Art of Service
Upon successful completion, you will receive a globally recognised Certificate of Completion issued by The Art of Service-a name trusted by over 12,000 professionals in quality, validation, and compliance roles across 93 countries. This certificate validates your mastery of ISO 14644 principles and strengthens your professional credibility with regulators, auditors, and leadership teams. No Hidden Fees. No Surprise Costs. Ever.
The price you see is the price you pay. There are no recurring fees, certification charges, or add-ons. Everything you need to master ISO 14644 and earn your certificate is included upfront. Accepted Payment Methods
- Visa
- Mastercard
- PayPal
100% Risk-Free Enrollment: Satisfied or Refunded Guarantee
We offer a full money-back guarantee if you're not completely satisfied. If, after reviewing the first two modules, you find the content isn't meeting your expectations, simply contact support for a prompt, no-questions-asked refund. What to Expect After Enrollment
After payment confirmation, you will receive an email receipt. Your course access credentials and detailed entry instructions will be sent in a separate message once your enrolment is fully processed. This ensures secure provisioning and accurate tracking. “Will This Work for Me?” – Addressing Your Biggest Concern
Whether you're new to cleanroom operations or a seasoned engineer, this course works because it was built for real-world complexity. It doesn't assume academic mastery. It assumes you need clarity, precision, and compliance-and it delivers accordingly. This works even if:
You've never written an ISO 14644 classification report.
You're transitioning from another standard (like FS 209E).
You're not a native English speaker.
You’re under pressure to pass an audit in the next 90 days. One project manager in a German medical device company used this course to resolve an FDA 483 observation related to unvalidated monitoring locations-successfully closing the deviation in 11 days. He had no background in environmental monitoring. He followed the system. It worked. You’re not buying information. You’re buying a proven, compliant pathway to cleanroom excellence-backed by real outcomes, expert guidance, and complete risk reversal.
Module 1: Foundations of ISO 14644 – Scope, Structure, and Core Principles - Introduction to ISO 14644: Purpose and global regulatory alignment
- Comparison with predecessor standards (e.g., FS 209E)
- Structure of ISO 14644 Parts 1–9: How they interrelate
- Understanding normative vs. informative content in standards
- Core definitions: Cleanroom, separative device, airborne particulate cleanliness
- The role of risk management in cleanroom classification
- Relationship between ISO 14644 and other standards (ISO 9001, EU GMP, FDA guidelines)
- Industry-specific applications: Pharma, biotech, medical devices, semiconductors, aerospace
- Responsibilities of facility owners, operators, and certification bodies
- Global acceptance and recognition of ISO 14644 compliance
Module 2: ISO 14644-1 – Classification of Air Cleanliness by Particle Concentration - Understanding ISO classification classes (ISO Class 1 to ISO Class 9)
- Particle size thresholds and concentration limits per cubic meter
- How to interpret the ISO classification table
- Determining required cleanliness levels based on process needs
- Static vs. dynamic conditions: When to apply each
- Sampling volume calculations for statistical validity
- Minimum number of sampling locations based on cleanroom floor area
- Grid layout planning and point distribution principles
- Selecting appropriate particle counters for ISO compliance testing
- Calibration and certification requirements for test equipment
- Step-by-step procedure for conducting an ISO 14644-1 classification test
- Recording and documenting sample data
- Common pitfalls in classification and how to avoid them
- Handling borderline results and retesting protocols
- Reporting structure for ISO classification certificates
Module 3: ISO 14644-2 – Monitoring to Provide Evidence of Cleanroom Performance - Transitioning from initial classification to ongoing monitoring
- Establishing a monitoring frequency based on risk assessment
- Identifying critical control points in cleanroom zones
- Designing a compliant routine monitoring programme
- Scheduled versus event-driven monitoring triggers
- Defining alert and action levels based on ISO class and operational state
- Documentation of monitoring results and trend analysis
- Use of control charts and statistical process control (SPC)
- Response procedures for excursions and out-of-limit events
- Corrective and preventive action (CAPA) integration
- Review and audit readiness of monitoring records
- Updating monitoring plans during facility changes
- Balancing resource constraints with regulatory expectations
- Integration with quality management systems (QMS)
- Best practices for shift reporting and handover documentation
Module 4: ISO 14644-3 – Test Methods for Measuring Airborne Particles and Other Parameters - Overview of all 25 test methods in ISO 14644-3
- Determining which tests apply to your facility classification
- Concentration of airborne particles (Test Method B)
- Particle size distribution analysis using sequential sampling
- Air velocity and uniformity testing (Test Method E)
- Airflow direction and visualization (Test Method F)
- Recovery and containment testing for separative devices
- Filter leakage tests using aerosol photometry (Test Method I)
- Integrity testing of HEPA and ULPA filters
- Air change rate calculations and verification
- Self-contained cleanroom recirculation efficiency
- Pressurization and pressure differential checks
- Containment leakage testing for glove boxes and isolators
- Testing for installed filter system performance
- Precision in instrumentation setup and environmental conditioning
- Developing standard operating procedures (SOPs) for each test
- Field validation of test protocols under operational stress
- Data logging and real-time readout best practices
- Handling non-compliant test results and requalification
- Integration of multiple test methods into a single qualification event
Module 5: Contamination Control Strategy (CCS) Development - Building a contamination control strategy aligned with ISO 14644
- Linking the CCS to product quality and patient safety
- Incorporating personnel, material, and process flow into the strategy
- Identifying potential sources of particulate and microbial contamination
- Role of facility design in contamination prevention
- Material transfer protocols and airlock usage
- Appropriate gowning procedures by ISO class
- Behavioural controls and human factor risk mitigation
- Environmental monitoring programme integration
- Change control considerations for CCS updates
- Documentation structure for regulatory submissions
- Alignment with PIC/S, EU GMP Annex 1, and FDA expectations
- Using risk assessment tools (e.g., FMEA) in CCS design
- Periodic review and effectiveness evaluation of the CCS
- Training personnel on their role in contamination control
Module 6: Cleanroom Design and Engineering Principles - Balancing ISO class requirements with architectural design
- Air handling unit (AHU) specifications for cleanroom performance
- Unidirectional (laminar) vs. non-unidirectional airflow systems
- Supply and return air grille placement for optimal flow
- Internal surface finishes and material compatibility
- Lighting, utilities, and service integration without contamination risk
- Sealing penetrations and joints for air tightness
- Static and electrical control measures
- Robustness of design against operational variability
- Scalability and future expansion planning
- Energy efficiency within cleanroom containment
- Commissioning phases: Factory Acceptance Test (FAT), Site Acceptance Test (SAT)
- Design verification against ISO performance criteria
- Interfacing with validation and qualification teams early in design
- Avoiding common design flaws that lead to non-compliance
Module 7: Installation and Operational Qualification (IQ/OQ) - Developing an IQ protocol for cleanroom systems
- Documenting equipment specifications and calibration status
- Verification of installation against design drawings
- Utility connections and safety interlocks
- Component traceability and manufacturer documentation
- Creating an OQ test matrix aligned with ISO 14644-3
- Executing airflow velocity and uniformity tests
- Performing pressure differential mapping
- Verifying alarm systems for critical parameters
- Filter integrity testing during OQ phase
- Personnel training and procedural documentation review
- Deviation management during qualification
- Executing OQ under static and dynamic conditions
- Reporting structure for IQ/OQ documentation
- Ensuring audit readiness of qualification packages
Module 8: Performance Qualification (PQ) and Reclassification - Developing a PQ protocol based on ISO 14644-1
- Defining operational load during testing (simulated or actual)
- Selecting monitoring locations for PQ based on risk
- Running multiple test cycles for reliability
- Airborne particle counts under dynamic conditions
- Documentation of environmental parameters (temp, humidity, pressure)
- Ensuring staff follow normal operational procedures during PQ
- Handling day-to-day variability in testing results
- Setting acceptance criteria for successful PQ completion
- Issue investigation and retesting procedures
- Formal sign-off and archiving of PQ reports
- Scheduling routine reclassification intervals
- Notification requirements for changes affecting classification
- Reclassification after major maintenance or construction
- Interfacing PQ with internal audit and regulatory inspection cycles
Module 9: ISO 14644-4 to 14644-9 – Specialized Applications and Advanced Topics - Design, construction, and start-up (ISO 14644-4)
- Operations (ISO 14644-5): Procedures, training, and discipline
- Test cleanrooms (ISO 14644-6): Special considerations for validation tools
- Separative devices (ISO 14644-7): Clean air hoods, gloveboxes, mini-environments
- Molecular contamination (ISO 14644-8): Gaseous contaminants and impact on processes
- Classification by chemical concentration (ISO 14644-9)
- Localized measurement of airborne molecular contamination (AMC)
- Material and surface cleanliness (ISO 14644-10)
- Leak testing of ductwork and enclosures
- Commissioning of separative devices under ISO 14644-7
- Calibration of test instrumentation per ISO 14644-3 and ISO 21501-4
- Use of simulations and computational fluid dynamics (CFD) in design validation
- Cleaning and disinfection strategies compatible with ISO standards
- Waste and personnel egress protocols
- Energy recovery systems in high-efficiency cleanrooms
Module 10: Regulatory Audits and Inspection Readiness - Preparing for health authority inspections (FDA, EMA, MHRA)
- Common audit findings related to ISO 14644 non-compliance
- Organizing cleanroom documentation for rapid retrieval
- Training staff on audit comportment and responses
- Pre-audit internal mock inspections
- Using ISO 14644 certificates as evidence of control
- Defending classification and monitoring decisions
- Clarifying scope of ISO 14644 vs. GMP expectations
- Responding to regulatory queries and observations
- Corrective action planning for identified gaps
- Integration with quality oversight committees
- Demonstrating continual improvement in cleanroom performance
- Managing third-party auditors and consultant reviews
- Documentation retention policies and digital archiving
- Using audit outcomes to strengthen internal controls
Module 11: Practical Application Projects and Real-World Simulations - Project 1: Designing a cleanroom classification plan for a Grade C filling room
- Determining sampling points using ISO 14644-1 formula
- Calculating minimum particle counter sampling duration
- Creating a monitoring map with specified locations
- Writing a full classification test protocol
- Executing simulated data collection and analysis
- Generating a pass/fail determination and formal report
- Project 2: Developing a corrective action following an excursion
- Root cause analysis using 5 Whys and fishbone diagrams
- Implementing temporary controls and reassessment
- Updating risk assessments and communication logs
- Project 3: Creating a Change Control for HVAC modification
- Assessing impact on classification and monitoring
- Requiring requalification after physical alteration
- Updating SOPs and training materials
- Project 4: Drafting a full Contamination Control Strategy
- Incorporating personnel flow, material transfer, and gowning
- Linking to environmental monitoring and alert systems
- Gaining quality unit approval and version control
- Presenting CCS to a mock quality review board
- Project 5: Responding to a mock FDA inspection query
- Retrieving classification certificates and trend reports
- Defending monitoring frequency and alarm limits
- Submitting a written response with supporting data
- Demonstrating continual compliance over 12 months
Module 12: Implementation Roadmap and Certification Preparation - Building a 90-day cleanroom compliance improvement plan
- Conducting a gap analysis against current ISO 14644 adherence
- Prioritizing actions based on risk and regulatory exposure
- Assigning ownership and accountability for each action
- Tracking progress with built-in checklists and templates
- Integrating improvements into daily operations
- Avoiding “project fatigue” and sustaining momentum
- Preparing for certification body assessment
- Selecting an accredited third-party auditor
- Understanding audit scope and deliverables
- Addressing non-conformities professionally and efficiently
- Final review of all documentation packages
- Submission of application for ISO 14644 certification
- Post-certification surveillance planning
- Using the Certificate of Completion issued by The Art of Service to demonstrate professional development
- Updating LinkedIn, CV, and internal profiles with certification
- Accessing advanced learning pathways in cleanroom management
- Joining a community of ISO 14644 practitioners and experts
- Receiving updates on changes to standards and industry best practices
- Leveraging your new expertise for promotions, project leadership, or consulting
- Introduction to ISO 14644: Purpose and global regulatory alignment
- Comparison with predecessor standards (e.g., FS 209E)
- Structure of ISO 14644 Parts 1–9: How they interrelate
- Understanding normative vs. informative content in standards
- Core definitions: Cleanroom, separative device, airborne particulate cleanliness
- The role of risk management in cleanroom classification
- Relationship between ISO 14644 and other standards (ISO 9001, EU GMP, FDA guidelines)
- Industry-specific applications: Pharma, biotech, medical devices, semiconductors, aerospace
- Responsibilities of facility owners, operators, and certification bodies
- Global acceptance and recognition of ISO 14644 compliance
Module 2: ISO 14644-1 – Classification of Air Cleanliness by Particle Concentration - Understanding ISO classification classes (ISO Class 1 to ISO Class 9)
- Particle size thresholds and concentration limits per cubic meter
- How to interpret the ISO classification table
- Determining required cleanliness levels based on process needs
- Static vs. dynamic conditions: When to apply each
- Sampling volume calculations for statistical validity
- Minimum number of sampling locations based on cleanroom floor area
- Grid layout planning and point distribution principles
- Selecting appropriate particle counters for ISO compliance testing
- Calibration and certification requirements for test equipment
- Step-by-step procedure for conducting an ISO 14644-1 classification test
- Recording and documenting sample data
- Common pitfalls in classification and how to avoid them
- Handling borderline results and retesting protocols
- Reporting structure for ISO classification certificates
Module 3: ISO 14644-2 – Monitoring to Provide Evidence of Cleanroom Performance - Transitioning from initial classification to ongoing monitoring
- Establishing a monitoring frequency based on risk assessment
- Identifying critical control points in cleanroom zones
- Designing a compliant routine monitoring programme
- Scheduled versus event-driven monitoring triggers
- Defining alert and action levels based on ISO class and operational state
- Documentation of monitoring results and trend analysis
- Use of control charts and statistical process control (SPC)
- Response procedures for excursions and out-of-limit events
- Corrective and preventive action (CAPA) integration
- Review and audit readiness of monitoring records
- Updating monitoring plans during facility changes
- Balancing resource constraints with regulatory expectations
- Integration with quality management systems (QMS)
- Best practices for shift reporting and handover documentation
Module 4: ISO 14644-3 – Test Methods for Measuring Airborne Particles and Other Parameters - Overview of all 25 test methods in ISO 14644-3
- Determining which tests apply to your facility classification
- Concentration of airborne particles (Test Method B)
- Particle size distribution analysis using sequential sampling
- Air velocity and uniformity testing (Test Method E)
- Airflow direction and visualization (Test Method F)
- Recovery and containment testing for separative devices
- Filter leakage tests using aerosol photometry (Test Method I)
- Integrity testing of HEPA and ULPA filters
- Air change rate calculations and verification
- Self-contained cleanroom recirculation efficiency
- Pressurization and pressure differential checks
- Containment leakage testing for glove boxes and isolators
- Testing for installed filter system performance
- Precision in instrumentation setup and environmental conditioning
- Developing standard operating procedures (SOPs) for each test
- Field validation of test protocols under operational stress
- Data logging and real-time readout best practices
- Handling non-compliant test results and requalification
- Integration of multiple test methods into a single qualification event
Module 5: Contamination Control Strategy (CCS) Development - Building a contamination control strategy aligned with ISO 14644
- Linking the CCS to product quality and patient safety
- Incorporating personnel, material, and process flow into the strategy
- Identifying potential sources of particulate and microbial contamination
- Role of facility design in contamination prevention
- Material transfer protocols and airlock usage
- Appropriate gowning procedures by ISO class
- Behavioural controls and human factor risk mitigation
- Environmental monitoring programme integration
- Change control considerations for CCS updates
- Documentation structure for regulatory submissions
- Alignment with PIC/S, EU GMP Annex 1, and FDA expectations
- Using risk assessment tools (e.g., FMEA) in CCS design
- Periodic review and effectiveness evaluation of the CCS
- Training personnel on their role in contamination control
Module 6: Cleanroom Design and Engineering Principles - Balancing ISO class requirements with architectural design
- Air handling unit (AHU) specifications for cleanroom performance
- Unidirectional (laminar) vs. non-unidirectional airflow systems
- Supply and return air grille placement for optimal flow
- Internal surface finishes and material compatibility
- Lighting, utilities, and service integration without contamination risk
- Sealing penetrations and joints for air tightness
- Static and electrical control measures
- Robustness of design against operational variability
- Scalability and future expansion planning
- Energy efficiency within cleanroom containment
- Commissioning phases: Factory Acceptance Test (FAT), Site Acceptance Test (SAT)
- Design verification against ISO performance criteria
- Interfacing with validation and qualification teams early in design
- Avoiding common design flaws that lead to non-compliance
Module 7: Installation and Operational Qualification (IQ/OQ) - Developing an IQ protocol for cleanroom systems
- Documenting equipment specifications and calibration status
- Verification of installation against design drawings
- Utility connections and safety interlocks
- Component traceability and manufacturer documentation
- Creating an OQ test matrix aligned with ISO 14644-3
- Executing airflow velocity and uniformity tests
- Performing pressure differential mapping
- Verifying alarm systems for critical parameters
- Filter integrity testing during OQ phase
- Personnel training and procedural documentation review
- Deviation management during qualification
- Executing OQ under static and dynamic conditions
- Reporting structure for IQ/OQ documentation
- Ensuring audit readiness of qualification packages
Module 8: Performance Qualification (PQ) and Reclassification - Developing a PQ protocol based on ISO 14644-1
- Defining operational load during testing (simulated or actual)
- Selecting monitoring locations for PQ based on risk
- Running multiple test cycles for reliability
- Airborne particle counts under dynamic conditions
- Documentation of environmental parameters (temp, humidity, pressure)
- Ensuring staff follow normal operational procedures during PQ
- Handling day-to-day variability in testing results
- Setting acceptance criteria for successful PQ completion
- Issue investigation and retesting procedures
- Formal sign-off and archiving of PQ reports
- Scheduling routine reclassification intervals
- Notification requirements for changes affecting classification
- Reclassification after major maintenance or construction
- Interfacing PQ with internal audit and regulatory inspection cycles
Module 9: ISO 14644-4 to 14644-9 – Specialized Applications and Advanced Topics - Design, construction, and start-up (ISO 14644-4)
- Operations (ISO 14644-5): Procedures, training, and discipline
- Test cleanrooms (ISO 14644-6): Special considerations for validation tools
- Separative devices (ISO 14644-7): Clean air hoods, gloveboxes, mini-environments
- Molecular contamination (ISO 14644-8): Gaseous contaminants and impact on processes
- Classification by chemical concentration (ISO 14644-9)
- Localized measurement of airborne molecular contamination (AMC)
- Material and surface cleanliness (ISO 14644-10)
- Leak testing of ductwork and enclosures
- Commissioning of separative devices under ISO 14644-7
- Calibration of test instrumentation per ISO 14644-3 and ISO 21501-4
- Use of simulations and computational fluid dynamics (CFD) in design validation
- Cleaning and disinfection strategies compatible with ISO standards
- Waste and personnel egress protocols
- Energy recovery systems in high-efficiency cleanrooms
Module 10: Regulatory Audits and Inspection Readiness - Preparing for health authority inspections (FDA, EMA, MHRA)
- Common audit findings related to ISO 14644 non-compliance
- Organizing cleanroom documentation for rapid retrieval
- Training staff on audit comportment and responses
- Pre-audit internal mock inspections
- Using ISO 14644 certificates as evidence of control
- Defending classification and monitoring decisions
- Clarifying scope of ISO 14644 vs. GMP expectations
- Responding to regulatory queries and observations
- Corrective action planning for identified gaps
- Integration with quality oversight committees
- Demonstrating continual improvement in cleanroom performance
- Managing third-party auditors and consultant reviews
- Documentation retention policies and digital archiving
- Using audit outcomes to strengthen internal controls
Module 11: Practical Application Projects and Real-World Simulations - Project 1: Designing a cleanroom classification plan for a Grade C filling room
- Determining sampling points using ISO 14644-1 formula
- Calculating minimum particle counter sampling duration
- Creating a monitoring map with specified locations
- Writing a full classification test protocol
- Executing simulated data collection and analysis
- Generating a pass/fail determination and formal report
- Project 2: Developing a corrective action following an excursion
- Root cause analysis using 5 Whys and fishbone diagrams
- Implementing temporary controls and reassessment
- Updating risk assessments and communication logs
- Project 3: Creating a Change Control for HVAC modification
- Assessing impact on classification and monitoring
- Requiring requalification after physical alteration
- Updating SOPs and training materials
- Project 4: Drafting a full Contamination Control Strategy
- Incorporating personnel flow, material transfer, and gowning
- Linking to environmental monitoring and alert systems
- Gaining quality unit approval and version control
- Presenting CCS to a mock quality review board
- Project 5: Responding to a mock FDA inspection query
- Retrieving classification certificates and trend reports
- Defending monitoring frequency and alarm limits
- Submitting a written response with supporting data
- Demonstrating continual compliance over 12 months
Module 12: Implementation Roadmap and Certification Preparation - Building a 90-day cleanroom compliance improvement plan
- Conducting a gap analysis against current ISO 14644 adherence
- Prioritizing actions based on risk and regulatory exposure
- Assigning ownership and accountability for each action
- Tracking progress with built-in checklists and templates
- Integrating improvements into daily operations
- Avoiding “project fatigue” and sustaining momentum
- Preparing for certification body assessment
- Selecting an accredited third-party auditor
- Understanding audit scope and deliverables
- Addressing non-conformities professionally and efficiently
- Final review of all documentation packages
- Submission of application for ISO 14644 certification
- Post-certification surveillance planning
- Using the Certificate of Completion issued by The Art of Service to demonstrate professional development
- Updating LinkedIn, CV, and internal profiles with certification
- Accessing advanced learning pathways in cleanroom management
- Joining a community of ISO 14644 practitioners and experts
- Receiving updates on changes to standards and industry best practices
- Leveraging your new expertise for promotions, project leadership, or consulting
- Transitioning from initial classification to ongoing monitoring
- Establishing a monitoring frequency based on risk assessment
- Identifying critical control points in cleanroom zones
- Designing a compliant routine monitoring programme
- Scheduled versus event-driven monitoring triggers
- Defining alert and action levels based on ISO class and operational state
- Documentation of monitoring results and trend analysis
- Use of control charts and statistical process control (SPC)
- Response procedures for excursions and out-of-limit events
- Corrective and preventive action (CAPA) integration
- Review and audit readiness of monitoring records
- Updating monitoring plans during facility changes
- Balancing resource constraints with regulatory expectations
- Integration with quality management systems (QMS)
- Best practices for shift reporting and handover documentation
Module 4: ISO 14644-3 – Test Methods for Measuring Airborne Particles and Other Parameters - Overview of all 25 test methods in ISO 14644-3
- Determining which tests apply to your facility classification
- Concentration of airborne particles (Test Method B)
- Particle size distribution analysis using sequential sampling
- Air velocity and uniformity testing (Test Method E)
- Airflow direction and visualization (Test Method F)
- Recovery and containment testing for separative devices
- Filter leakage tests using aerosol photometry (Test Method I)
- Integrity testing of HEPA and ULPA filters
- Air change rate calculations and verification
- Self-contained cleanroom recirculation efficiency
- Pressurization and pressure differential checks
- Containment leakage testing for glove boxes and isolators
- Testing for installed filter system performance
- Precision in instrumentation setup and environmental conditioning
- Developing standard operating procedures (SOPs) for each test
- Field validation of test protocols under operational stress
- Data logging and real-time readout best practices
- Handling non-compliant test results and requalification
- Integration of multiple test methods into a single qualification event
Module 5: Contamination Control Strategy (CCS) Development - Building a contamination control strategy aligned with ISO 14644
- Linking the CCS to product quality and patient safety
- Incorporating personnel, material, and process flow into the strategy
- Identifying potential sources of particulate and microbial contamination
- Role of facility design in contamination prevention
- Material transfer protocols and airlock usage
- Appropriate gowning procedures by ISO class
- Behavioural controls and human factor risk mitigation
- Environmental monitoring programme integration
- Change control considerations for CCS updates
- Documentation structure for regulatory submissions
- Alignment with PIC/S, EU GMP Annex 1, and FDA expectations
- Using risk assessment tools (e.g., FMEA) in CCS design
- Periodic review and effectiveness evaluation of the CCS
- Training personnel on their role in contamination control
Module 6: Cleanroom Design and Engineering Principles - Balancing ISO class requirements with architectural design
- Air handling unit (AHU) specifications for cleanroom performance
- Unidirectional (laminar) vs. non-unidirectional airflow systems
- Supply and return air grille placement for optimal flow
- Internal surface finishes and material compatibility
- Lighting, utilities, and service integration without contamination risk
- Sealing penetrations and joints for air tightness
- Static and electrical control measures
- Robustness of design against operational variability
- Scalability and future expansion planning
- Energy efficiency within cleanroom containment
- Commissioning phases: Factory Acceptance Test (FAT), Site Acceptance Test (SAT)
- Design verification against ISO performance criteria
- Interfacing with validation and qualification teams early in design
- Avoiding common design flaws that lead to non-compliance
Module 7: Installation and Operational Qualification (IQ/OQ) - Developing an IQ protocol for cleanroom systems
- Documenting equipment specifications and calibration status
- Verification of installation against design drawings
- Utility connections and safety interlocks
- Component traceability and manufacturer documentation
- Creating an OQ test matrix aligned with ISO 14644-3
- Executing airflow velocity and uniformity tests
- Performing pressure differential mapping
- Verifying alarm systems for critical parameters
- Filter integrity testing during OQ phase
- Personnel training and procedural documentation review
- Deviation management during qualification
- Executing OQ under static and dynamic conditions
- Reporting structure for IQ/OQ documentation
- Ensuring audit readiness of qualification packages
Module 8: Performance Qualification (PQ) and Reclassification - Developing a PQ protocol based on ISO 14644-1
- Defining operational load during testing (simulated or actual)
- Selecting monitoring locations for PQ based on risk
- Running multiple test cycles for reliability
- Airborne particle counts under dynamic conditions
- Documentation of environmental parameters (temp, humidity, pressure)
- Ensuring staff follow normal operational procedures during PQ
- Handling day-to-day variability in testing results
- Setting acceptance criteria for successful PQ completion
- Issue investigation and retesting procedures
- Formal sign-off and archiving of PQ reports
- Scheduling routine reclassification intervals
- Notification requirements for changes affecting classification
- Reclassification after major maintenance or construction
- Interfacing PQ with internal audit and regulatory inspection cycles
Module 9: ISO 14644-4 to 14644-9 – Specialized Applications and Advanced Topics - Design, construction, and start-up (ISO 14644-4)
- Operations (ISO 14644-5): Procedures, training, and discipline
- Test cleanrooms (ISO 14644-6): Special considerations for validation tools
- Separative devices (ISO 14644-7): Clean air hoods, gloveboxes, mini-environments
- Molecular contamination (ISO 14644-8): Gaseous contaminants and impact on processes
- Classification by chemical concentration (ISO 14644-9)
- Localized measurement of airborne molecular contamination (AMC)
- Material and surface cleanliness (ISO 14644-10)
- Leak testing of ductwork and enclosures
- Commissioning of separative devices under ISO 14644-7
- Calibration of test instrumentation per ISO 14644-3 and ISO 21501-4
- Use of simulations and computational fluid dynamics (CFD) in design validation
- Cleaning and disinfection strategies compatible with ISO standards
- Waste and personnel egress protocols
- Energy recovery systems in high-efficiency cleanrooms
Module 10: Regulatory Audits and Inspection Readiness - Preparing for health authority inspections (FDA, EMA, MHRA)
- Common audit findings related to ISO 14644 non-compliance
- Organizing cleanroom documentation for rapid retrieval
- Training staff on audit comportment and responses
- Pre-audit internal mock inspections
- Using ISO 14644 certificates as evidence of control
- Defending classification and monitoring decisions
- Clarifying scope of ISO 14644 vs. GMP expectations
- Responding to regulatory queries and observations
- Corrective action planning for identified gaps
- Integration with quality oversight committees
- Demonstrating continual improvement in cleanroom performance
- Managing third-party auditors and consultant reviews
- Documentation retention policies and digital archiving
- Using audit outcomes to strengthen internal controls
Module 11: Practical Application Projects and Real-World Simulations - Project 1: Designing a cleanroom classification plan for a Grade C filling room
- Determining sampling points using ISO 14644-1 formula
- Calculating minimum particle counter sampling duration
- Creating a monitoring map with specified locations
- Writing a full classification test protocol
- Executing simulated data collection and analysis
- Generating a pass/fail determination and formal report
- Project 2: Developing a corrective action following an excursion
- Root cause analysis using 5 Whys and fishbone diagrams
- Implementing temporary controls and reassessment
- Updating risk assessments and communication logs
- Project 3: Creating a Change Control for HVAC modification
- Assessing impact on classification and monitoring
- Requiring requalification after physical alteration
- Updating SOPs and training materials
- Project 4: Drafting a full Contamination Control Strategy
- Incorporating personnel flow, material transfer, and gowning
- Linking to environmental monitoring and alert systems
- Gaining quality unit approval and version control
- Presenting CCS to a mock quality review board
- Project 5: Responding to a mock FDA inspection query
- Retrieving classification certificates and trend reports
- Defending monitoring frequency and alarm limits
- Submitting a written response with supporting data
- Demonstrating continual compliance over 12 months
Module 12: Implementation Roadmap and Certification Preparation - Building a 90-day cleanroom compliance improvement plan
- Conducting a gap analysis against current ISO 14644 adherence
- Prioritizing actions based on risk and regulatory exposure
- Assigning ownership and accountability for each action
- Tracking progress with built-in checklists and templates
- Integrating improvements into daily operations
- Avoiding “project fatigue” and sustaining momentum
- Preparing for certification body assessment
- Selecting an accredited third-party auditor
- Understanding audit scope and deliverables
- Addressing non-conformities professionally and efficiently
- Final review of all documentation packages
- Submission of application for ISO 14644 certification
- Post-certification surveillance planning
- Using the Certificate of Completion issued by The Art of Service to demonstrate professional development
- Updating LinkedIn, CV, and internal profiles with certification
- Accessing advanced learning pathways in cleanroom management
- Joining a community of ISO 14644 practitioners and experts
- Receiving updates on changes to standards and industry best practices
- Leveraging your new expertise for promotions, project leadership, or consulting
- Building a contamination control strategy aligned with ISO 14644
- Linking the CCS to product quality and patient safety
- Incorporating personnel, material, and process flow into the strategy
- Identifying potential sources of particulate and microbial contamination
- Role of facility design in contamination prevention
- Material transfer protocols and airlock usage
- Appropriate gowning procedures by ISO class
- Behavioural controls and human factor risk mitigation
- Environmental monitoring programme integration
- Change control considerations for CCS updates
- Documentation structure for regulatory submissions
- Alignment with PIC/S, EU GMP Annex 1, and FDA expectations
- Using risk assessment tools (e.g., FMEA) in CCS design
- Periodic review and effectiveness evaluation of the CCS
- Training personnel on their role in contamination control
Module 6: Cleanroom Design and Engineering Principles - Balancing ISO class requirements with architectural design
- Air handling unit (AHU) specifications for cleanroom performance
- Unidirectional (laminar) vs. non-unidirectional airflow systems
- Supply and return air grille placement for optimal flow
- Internal surface finishes and material compatibility
- Lighting, utilities, and service integration without contamination risk
- Sealing penetrations and joints for air tightness
- Static and electrical control measures
- Robustness of design against operational variability
- Scalability and future expansion planning
- Energy efficiency within cleanroom containment
- Commissioning phases: Factory Acceptance Test (FAT), Site Acceptance Test (SAT)
- Design verification against ISO performance criteria
- Interfacing with validation and qualification teams early in design
- Avoiding common design flaws that lead to non-compliance
Module 7: Installation and Operational Qualification (IQ/OQ) - Developing an IQ protocol for cleanroom systems
- Documenting equipment specifications and calibration status
- Verification of installation against design drawings
- Utility connections and safety interlocks
- Component traceability and manufacturer documentation
- Creating an OQ test matrix aligned with ISO 14644-3
- Executing airflow velocity and uniformity tests
- Performing pressure differential mapping
- Verifying alarm systems for critical parameters
- Filter integrity testing during OQ phase
- Personnel training and procedural documentation review
- Deviation management during qualification
- Executing OQ under static and dynamic conditions
- Reporting structure for IQ/OQ documentation
- Ensuring audit readiness of qualification packages
Module 8: Performance Qualification (PQ) and Reclassification - Developing a PQ protocol based on ISO 14644-1
- Defining operational load during testing (simulated or actual)
- Selecting monitoring locations for PQ based on risk
- Running multiple test cycles for reliability
- Airborne particle counts under dynamic conditions
- Documentation of environmental parameters (temp, humidity, pressure)
- Ensuring staff follow normal operational procedures during PQ
- Handling day-to-day variability in testing results
- Setting acceptance criteria for successful PQ completion
- Issue investigation and retesting procedures
- Formal sign-off and archiving of PQ reports
- Scheduling routine reclassification intervals
- Notification requirements for changes affecting classification
- Reclassification after major maintenance or construction
- Interfacing PQ with internal audit and regulatory inspection cycles
Module 9: ISO 14644-4 to 14644-9 – Specialized Applications and Advanced Topics - Design, construction, and start-up (ISO 14644-4)
- Operations (ISO 14644-5): Procedures, training, and discipline
- Test cleanrooms (ISO 14644-6): Special considerations for validation tools
- Separative devices (ISO 14644-7): Clean air hoods, gloveboxes, mini-environments
- Molecular contamination (ISO 14644-8): Gaseous contaminants and impact on processes
- Classification by chemical concentration (ISO 14644-9)
- Localized measurement of airborne molecular contamination (AMC)
- Material and surface cleanliness (ISO 14644-10)
- Leak testing of ductwork and enclosures
- Commissioning of separative devices under ISO 14644-7
- Calibration of test instrumentation per ISO 14644-3 and ISO 21501-4
- Use of simulations and computational fluid dynamics (CFD) in design validation
- Cleaning and disinfection strategies compatible with ISO standards
- Waste and personnel egress protocols
- Energy recovery systems in high-efficiency cleanrooms
Module 10: Regulatory Audits and Inspection Readiness - Preparing for health authority inspections (FDA, EMA, MHRA)
- Common audit findings related to ISO 14644 non-compliance
- Organizing cleanroom documentation for rapid retrieval
- Training staff on audit comportment and responses
- Pre-audit internal mock inspections
- Using ISO 14644 certificates as evidence of control
- Defending classification and monitoring decisions
- Clarifying scope of ISO 14644 vs. GMP expectations
- Responding to regulatory queries and observations
- Corrective action planning for identified gaps
- Integration with quality oversight committees
- Demonstrating continual improvement in cleanroom performance
- Managing third-party auditors and consultant reviews
- Documentation retention policies and digital archiving
- Using audit outcomes to strengthen internal controls
Module 11: Practical Application Projects and Real-World Simulations - Project 1: Designing a cleanroom classification plan for a Grade C filling room
- Determining sampling points using ISO 14644-1 formula
- Calculating minimum particle counter sampling duration
- Creating a monitoring map with specified locations
- Writing a full classification test protocol
- Executing simulated data collection and analysis
- Generating a pass/fail determination and formal report
- Project 2: Developing a corrective action following an excursion
- Root cause analysis using 5 Whys and fishbone diagrams
- Implementing temporary controls and reassessment
- Updating risk assessments and communication logs
- Project 3: Creating a Change Control for HVAC modification
- Assessing impact on classification and monitoring
- Requiring requalification after physical alteration
- Updating SOPs and training materials
- Project 4: Drafting a full Contamination Control Strategy
- Incorporating personnel flow, material transfer, and gowning
- Linking to environmental monitoring and alert systems
- Gaining quality unit approval and version control
- Presenting CCS to a mock quality review board
- Project 5: Responding to a mock FDA inspection query
- Retrieving classification certificates and trend reports
- Defending monitoring frequency and alarm limits
- Submitting a written response with supporting data
- Demonstrating continual compliance over 12 months
Module 12: Implementation Roadmap and Certification Preparation - Building a 90-day cleanroom compliance improvement plan
- Conducting a gap analysis against current ISO 14644 adherence
- Prioritizing actions based on risk and regulatory exposure
- Assigning ownership and accountability for each action
- Tracking progress with built-in checklists and templates
- Integrating improvements into daily operations
- Avoiding “project fatigue” and sustaining momentum
- Preparing for certification body assessment
- Selecting an accredited third-party auditor
- Understanding audit scope and deliverables
- Addressing non-conformities professionally and efficiently
- Final review of all documentation packages
- Submission of application for ISO 14644 certification
- Post-certification surveillance planning
- Using the Certificate of Completion issued by The Art of Service to demonstrate professional development
- Updating LinkedIn, CV, and internal profiles with certification
- Accessing advanced learning pathways in cleanroom management
- Joining a community of ISO 14644 practitioners and experts
- Receiving updates on changes to standards and industry best practices
- Leveraging your new expertise for promotions, project leadership, or consulting
- Developing an IQ protocol for cleanroom systems
- Documenting equipment specifications and calibration status
- Verification of installation against design drawings
- Utility connections and safety interlocks
- Component traceability and manufacturer documentation
- Creating an OQ test matrix aligned with ISO 14644-3
- Executing airflow velocity and uniformity tests
- Performing pressure differential mapping
- Verifying alarm systems for critical parameters
- Filter integrity testing during OQ phase
- Personnel training and procedural documentation review
- Deviation management during qualification
- Executing OQ under static and dynamic conditions
- Reporting structure for IQ/OQ documentation
- Ensuring audit readiness of qualification packages
Module 8: Performance Qualification (PQ) and Reclassification - Developing a PQ protocol based on ISO 14644-1
- Defining operational load during testing (simulated or actual)
- Selecting monitoring locations for PQ based on risk
- Running multiple test cycles for reliability
- Airborne particle counts under dynamic conditions
- Documentation of environmental parameters (temp, humidity, pressure)
- Ensuring staff follow normal operational procedures during PQ
- Handling day-to-day variability in testing results
- Setting acceptance criteria for successful PQ completion
- Issue investigation and retesting procedures
- Formal sign-off and archiving of PQ reports
- Scheduling routine reclassification intervals
- Notification requirements for changes affecting classification
- Reclassification after major maintenance or construction
- Interfacing PQ with internal audit and regulatory inspection cycles
Module 9: ISO 14644-4 to 14644-9 – Specialized Applications and Advanced Topics - Design, construction, and start-up (ISO 14644-4)
- Operations (ISO 14644-5): Procedures, training, and discipline
- Test cleanrooms (ISO 14644-6): Special considerations for validation tools
- Separative devices (ISO 14644-7): Clean air hoods, gloveboxes, mini-environments
- Molecular contamination (ISO 14644-8): Gaseous contaminants and impact on processes
- Classification by chemical concentration (ISO 14644-9)
- Localized measurement of airborne molecular contamination (AMC)
- Material and surface cleanliness (ISO 14644-10)
- Leak testing of ductwork and enclosures
- Commissioning of separative devices under ISO 14644-7
- Calibration of test instrumentation per ISO 14644-3 and ISO 21501-4
- Use of simulations and computational fluid dynamics (CFD) in design validation
- Cleaning and disinfection strategies compatible with ISO standards
- Waste and personnel egress protocols
- Energy recovery systems in high-efficiency cleanrooms
Module 10: Regulatory Audits and Inspection Readiness - Preparing for health authority inspections (FDA, EMA, MHRA)
- Common audit findings related to ISO 14644 non-compliance
- Organizing cleanroom documentation for rapid retrieval
- Training staff on audit comportment and responses
- Pre-audit internal mock inspections
- Using ISO 14644 certificates as evidence of control
- Defending classification and monitoring decisions
- Clarifying scope of ISO 14644 vs. GMP expectations
- Responding to regulatory queries and observations
- Corrective action planning for identified gaps
- Integration with quality oversight committees
- Demonstrating continual improvement in cleanroom performance
- Managing third-party auditors and consultant reviews
- Documentation retention policies and digital archiving
- Using audit outcomes to strengthen internal controls
Module 11: Practical Application Projects and Real-World Simulations - Project 1: Designing a cleanroom classification plan for a Grade C filling room
- Determining sampling points using ISO 14644-1 formula
- Calculating minimum particle counter sampling duration
- Creating a monitoring map with specified locations
- Writing a full classification test protocol
- Executing simulated data collection and analysis
- Generating a pass/fail determination and formal report
- Project 2: Developing a corrective action following an excursion
- Root cause analysis using 5 Whys and fishbone diagrams
- Implementing temporary controls and reassessment
- Updating risk assessments and communication logs
- Project 3: Creating a Change Control for HVAC modification
- Assessing impact on classification and monitoring
- Requiring requalification after physical alteration
- Updating SOPs and training materials
- Project 4: Drafting a full Contamination Control Strategy
- Incorporating personnel flow, material transfer, and gowning
- Linking to environmental monitoring and alert systems
- Gaining quality unit approval and version control
- Presenting CCS to a mock quality review board
- Project 5: Responding to a mock FDA inspection query
- Retrieving classification certificates and trend reports
- Defending monitoring frequency and alarm limits
- Submitting a written response with supporting data
- Demonstrating continual compliance over 12 months
Module 12: Implementation Roadmap and Certification Preparation - Building a 90-day cleanroom compliance improvement plan
- Conducting a gap analysis against current ISO 14644 adherence
- Prioritizing actions based on risk and regulatory exposure
- Assigning ownership and accountability for each action
- Tracking progress with built-in checklists and templates
- Integrating improvements into daily operations
- Avoiding “project fatigue” and sustaining momentum
- Preparing for certification body assessment
- Selecting an accredited third-party auditor
- Understanding audit scope and deliverables
- Addressing non-conformities professionally and efficiently
- Final review of all documentation packages
- Submission of application for ISO 14644 certification
- Post-certification surveillance planning
- Using the Certificate of Completion issued by The Art of Service to demonstrate professional development
- Updating LinkedIn, CV, and internal profiles with certification
- Accessing advanced learning pathways in cleanroom management
- Joining a community of ISO 14644 practitioners and experts
- Receiving updates on changes to standards and industry best practices
- Leveraging your new expertise for promotions, project leadership, or consulting
- Design, construction, and start-up (ISO 14644-4)
- Operations (ISO 14644-5): Procedures, training, and discipline
- Test cleanrooms (ISO 14644-6): Special considerations for validation tools
- Separative devices (ISO 14644-7): Clean air hoods, gloveboxes, mini-environments
- Molecular contamination (ISO 14644-8): Gaseous contaminants and impact on processes
- Classification by chemical concentration (ISO 14644-9)
- Localized measurement of airborne molecular contamination (AMC)
- Material and surface cleanliness (ISO 14644-10)
- Leak testing of ductwork and enclosures
- Commissioning of separative devices under ISO 14644-7
- Calibration of test instrumentation per ISO 14644-3 and ISO 21501-4
- Use of simulations and computational fluid dynamics (CFD) in design validation
- Cleaning and disinfection strategies compatible with ISO standards
- Waste and personnel egress protocols
- Energy recovery systems in high-efficiency cleanrooms
Module 10: Regulatory Audits and Inspection Readiness - Preparing for health authority inspections (FDA, EMA, MHRA)
- Common audit findings related to ISO 14644 non-compliance
- Organizing cleanroom documentation for rapid retrieval
- Training staff on audit comportment and responses
- Pre-audit internal mock inspections
- Using ISO 14644 certificates as evidence of control
- Defending classification and monitoring decisions
- Clarifying scope of ISO 14644 vs. GMP expectations
- Responding to regulatory queries and observations
- Corrective action planning for identified gaps
- Integration with quality oversight committees
- Demonstrating continual improvement in cleanroom performance
- Managing third-party auditors and consultant reviews
- Documentation retention policies and digital archiving
- Using audit outcomes to strengthen internal controls
Module 11: Practical Application Projects and Real-World Simulations - Project 1: Designing a cleanroom classification plan for a Grade C filling room
- Determining sampling points using ISO 14644-1 formula
- Calculating minimum particle counter sampling duration
- Creating a monitoring map with specified locations
- Writing a full classification test protocol
- Executing simulated data collection and analysis
- Generating a pass/fail determination and formal report
- Project 2: Developing a corrective action following an excursion
- Root cause analysis using 5 Whys and fishbone diagrams
- Implementing temporary controls and reassessment
- Updating risk assessments and communication logs
- Project 3: Creating a Change Control for HVAC modification
- Assessing impact on classification and monitoring
- Requiring requalification after physical alteration
- Updating SOPs and training materials
- Project 4: Drafting a full Contamination Control Strategy
- Incorporating personnel flow, material transfer, and gowning
- Linking to environmental monitoring and alert systems
- Gaining quality unit approval and version control
- Presenting CCS to a mock quality review board
- Project 5: Responding to a mock FDA inspection query
- Retrieving classification certificates and trend reports
- Defending monitoring frequency and alarm limits
- Submitting a written response with supporting data
- Demonstrating continual compliance over 12 months
Module 12: Implementation Roadmap and Certification Preparation - Building a 90-day cleanroom compliance improvement plan
- Conducting a gap analysis against current ISO 14644 adherence
- Prioritizing actions based on risk and regulatory exposure
- Assigning ownership and accountability for each action
- Tracking progress with built-in checklists and templates
- Integrating improvements into daily operations
- Avoiding “project fatigue” and sustaining momentum
- Preparing for certification body assessment
- Selecting an accredited third-party auditor
- Understanding audit scope and deliverables
- Addressing non-conformities professionally and efficiently
- Final review of all documentation packages
- Submission of application for ISO 14644 certification
- Post-certification surveillance planning
- Using the Certificate of Completion issued by The Art of Service to demonstrate professional development
- Updating LinkedIn, CV, and internal profiles with certification
- Accessing advanced learning pathways in cleanroom management
- Joining a community of ISO 14644 practitioners and experts
- Receiving updates on changes to standards and industry best practices
- Leveraging your new expertise for promotions, project leadership, or consulting
- Project 1: Designing a cleanroom classification plan for a Grade C filling room
- Determining sampling points using ISO 14644-1 formula
- Calculating minimum particle counter sampling duration
- Creating a monitoring map with specified locations
- Writing a full classification test protocol
- Executing simulated data collection and analysis
- Generating a pass/fail determination and formal report
- Project 2: Developing a corrective action following an excursion
- Root cause analysis using 5 Whys and fishbone diagrams
- Implementing temporary controls and reassessment
- Updating risk assessments and communication logs
- Project 3: Creating a Change Control for HVAC modification
- Assessing impact on classification and monitoring
- Requiring requalification after physical alteration
- Updating SOPs and training materials
- Project 4: Drafting a full Contamination Control Strategy
- Incorporating personnel flow, material transfer, and gowning
- Linking to environmental monitoring and alert systems
- Gaining quality unit approval and version control
- Presenting CCS to a mock quality review board
- Project 5: Responding to a mock FDA inspection query
- Retrieving classification certificates and trend reports
- Defending monitoring frequency and alarm limits
- Submitting a written response with supporting data
- Demonstrating continual compliance over 12 months