Mastering Good Laboratory Practice for Regulatory Compliance and Career Advancement
You're working late again, triple-checking documentation, second-guessing procedures, and dreading the next audit. You know that one small deviation could trigger a compliance red flag, delay a product release, or worse-jeopardize your lab's regulatory standing. The stakes have never been higher. Regulatory inspectors are watching. Management is demanding flawless documentation. And you need to prove you’re not just following protocols-you’re mastering them. But most training is outdated, oversimplified, or disconnected from real-world lab challenges. The Mastering Good Laboratory Practice for Regulatory Compliance and Career Advancement course is your definitive solution. This is not theory. It’s a proven, system-driven path to implementing GLP with precision, passing audits with confidence, and transforming your role from technician to trusted compliance leader. One recent participant-Maria T., Senior Analytical Chemist at a biotech CRO-used this course to redesign her lab’s record-keeping system. Within two months, her team reduced non-conformances by 78% and passed an FDA pre-approval inspection with zero observations. She was promoted to Laboratory Compliance Lead shortly after. Imagine walking into your next audit knowing every protocol, every form, every decision trail is airtight. No last-minute scrambles. No fear of findings. Just undeniable proof of excellence. Imagine being the person leadership turns to when standards shift-because you’re already ahead of the curve. No more stagnation. No more being overlooked. This course gets you from stressed check-box performer to confident GLP authority-in under 30 days-with a documented, board-ready compliance framework you can implement immediately. Here’s how this course is structured to help you get there.Course Format & Delivery Details Self-Paced, On-Demand Learning with Immediate Online Access
This course is fully self-paced and delivered online for immediate access. Once enrolled, you can begin right away-no waiting for cohorts, no rigid schedules. Learn on your time, from any location, at any hour. Most learners complete the program within 20-25 hours, with many applying core compliance frameworks in their labs within the first week. Tangible results-like audit-ready documentation, staff training templates, and SOP improvements-are achievable in as little as 10 days. Lifetime Access & Continuous Updates
You receive lifetime access to all course materials. Regulatory standards evolve, and so does this course. All future updates are included at no extra cost-ensuring your knowledge remains current, relevant, and globally compliant for years to come. Access is available 24/7 across devices. Whether you’re reviewing a checklist on your phone during a break or updating lab templates on your tablet, the content is optimized for seamless mobile use. Expert Guidance & Direct Support
You are not learning in isolation. This course includes direct, responsive instructor support. Our GLP-certified compliance specialists-with decades of combined experience in regulated laboratories-are available to review your questions, clarify complex standards, and provide real-world implementation guidance. Need feedback on a draft SOP? A second opinion on an inspection response plan? Submit your query and receive detailed, actionable responses-designed to get you unstuck and moving forward fast. Certificate of Completion: A Globally Recognised Credential
Upon successful completion, you earn a Certificate of Completion issued by The Art of Service. This is not a participation badge. It's a verified credential recognised by employers, auditors, and industry leaders across pharmaceuticals, biotechnology, environmental testing, and medical devices. The certificate validates your mastery of current GLP standards, documentation rigor, and audit preparedness-signalling to employers that you operate at the highest level of regulatory professionalism. Transparent Pricing & Risk-Free Enrollment
Pricing is straightforward with no hidden fees. What you see is exactly what you pay-no surprises, no recurring charges, no upsells. We accept all major payment methods including Visa, Mastercard, and PayPal-securely processed with bank-level encryption. Confidence Without Consequence: 30-Day Satisfaction Guarantee
Enroll with absolute confidence. If this course doesn’t meet your expectations, you’re covered by our 30-day satisfaction guarantee. Request a full refund-no questions asked. Your investment is 100% protected. Zero-Risk Onboarding: What Happens After Enrollment
After enrollment, you’ll receive a confirmation email. Your access details and course materials will be delivered separately once they are ready for optimal learning delivery. This ensures you receive a polished, error-free experience-so your learning starts strong. “Will This Work for Me?”-We’ve Got You Covered
Whether you’re a junior lab technician, a QA officer, a study director, or a lab manager, this course is structured to meet you where you are. Every module is designed to be immediately applicable, regardless of your current lab environment or regulatory jurisdiction. This works even if you’ve never led an audit, if your lab has a history of non-conformances, if you’re transitioning from research to regulated testing, or if you’re preparing for your first GLP inspection under FDA or EMA standards. One quality control supervisor in Sweden used this course to standardise documentation across three labs-before a major EU Notified Body audit. His team passed with zero critical findings. He credits the course templates and implementation checklists as “the backbone of our success.” This is not generic theory. It’s a field-tested system used by high-performing labs worldwide. You get the exact tools, templates, and decision frameworks that top compliance professionals rely on daily. Your success isn’t left to chance. With lifetime access, expert support, guaranteed outcomes, and a globally respected certificate, you’re backed at every step.
Module 1: Foundations of Good Laboratory Practice - Introduction to GLP: Definition, scope, and global relevance
- Historical development of GLP standards and regulatory milestones
- Core principles of Good Laboratory Practice
- Differences between GLP, GMP, and ISO standards
- Understanding the role of OECD GLP principles
- Application of GLP in pharmaceutical, environmental, and chemical testing
- The impact of poor laboratory practice on regulatory approval
- Role of national regulatory bodies in GLP enforcement
- Key terminology and acronyms in GLP compliance
- Understanding the GLP compliance lifecycle
Module 2: Regulatory Frameworks and Global Compliance Requirements - Overview of FDA 21 CFR Part 58 and its requirements
- Understanding EMA GLP guidelines and inspection processes
- ISO/IEC 17025 and its relationship with GLP
- Health Canada’s GLP standards and compliance expectations
- MHRA and OECD GLP compliance in the UK
- GLP requirements in Japan, South Korea, and Asia-Pacific markets
- Differences between regional regulatory expectations
- Preparing for multinational study submissions
- Understanding mutual acceptance of GLP data (MAD)
- Regulatory updates and how to track them proactively
Module 3: Organizational Structure and Personnel Responsibilities - Defining the roles of Study Director, Principal Investigator, and Sponsor
- Training requirements for GLP-compliant staff
- Qualifications and responsibilities of the Quality Assurance Unit (QAU)
- Role of the Test Facility Management in GLP adherence
- Documentation of staff training and competency records
- Handling personnel changes during a study
- Defining responsibilities for data integrity and record-keeping
- Staff supervision and accountability structures
- Developing GLP-specific job descriptions
- Managing third-party contractors under GLP
Module 4: Quality Assurance Unit (QAU) Structure and Functions - Establishing an independent Quality Assurance Unit
- Core responsibilities of the QAU in study oversight
- Developing a Master Schedule of studies
- Creating and managing formal audits and inspections
- Writing and tracking audit findings and corrective actions
- Conducting routine and study-specific QA audits
- Role of QA in raw data verification
- Reporting QA findings to management and study teams
- Ensuring QAU independence and objectivity
- Documenting QA activities and inspection readiness
Module 5: Study Planning and Protocol Development - Elements of a GLP-compliant study protocol
- Defining test and control articles with traceability
- Determining study objectives and acceptance criteria
- Incorporating statistical design in protocol planning
- Pre-approval requirements for protocol finalisation
- Handling protocol amendments and version control
- Obtaining sponsor approval and documenting consent
- Ensuring scientific rigor and regulatory alignment
- Defining test system parameters and monitoring frequency
- Integrating safety and animal welfare considerations
Module 6: Test and Control Article Management - Receipt, identification, and storage of test articles
- Stability and shelf-life monitoring systems
- Preparation and dosing formulation documentation
- Chain of custody for control substances
- Labelling requirements for test articles in compliance
- Handling hazardous materials under GLP
- Inventory tracking systems and audit trails
- Disposal procedures with documented justification
- Sample retention periods and storage conditions
- Re-test schedules and stability protocol alignment
Module 7: Test System Management and Husbandry - Selecting appropriate test systems: rodents, in vitro, etc.
- Animal welfare and ethical oversight requirements
- Facility design for hygiene and environmental control
- Maintaining health monitoring records for animal colonies
- Feeding, bedding, and environmental enrichment standards
- Pre-study acclimatisation and quarantine procedures
- Health surveillance and veterinary care documentation
- Handling unexpected animal health events
- Preventing cross-contamination in multi-study labs
- Documenting procedures for euthanasia and disposal
Module 8: Facility Design and Maintenance - GLP requirements for laboratory physical design
- Separation of clean, contaminated, and waste areas
- Climate control and environmental monitoring logs
- HVAC system validation and maintenance records
- Water, gas, and electrical system documentation
- Security and access control in regulated labs
- Waste handling and decontamination zones
- Emergency preparedness and response planning
- Maintenance logs for laboratory equipment
- Facility inspections and infrastructure audits
Module 9: Equipment Calibration and Maintenance - Establishing a comprehensive equipment inventory
- Calibration schedules based on risk and use frequency
- Documenting calibration results with traceable standards
- Preventive maintenance planning and tracking
- Out-of-calibration investigation and impact assessment
- Equipment logbooks and electronic maintenance records
- Vendor qualification for repair and calibration services
- Requalification after maintenance or relocation
- Temperature mapping for refrigerators and incubators
- Digital calibration management systems
Module 10: Raw Data and Record Management - Definition of raw data in GLP environments
- Acceptable formats: paper, electronic, hybrid systems
- Real-time recording requirements and best practices
- Ensuring data attributable, legible, contemporaneous, original, and accurate (ALCOA+)
- Correcting entries: strike-through, reason, signature, date
- Handling incomplete or missing data entries
- Witnessing and co-signing critical data points
- Storage conditions for paper records
- Retention periods aligned with regulatory expectations
- Audit trail requirements for electronic data systems
Module 11: Standard Operating Procedures (SOPs) - Developing a master list of lab SOPs
- Writing clear, step-by-step, enforceable procedures
- Version control and change management for SOPs
- Approval process involving QA and management
- Ensuring SOPs reflect actual lab practices
- Training staff on new or revised SOPs
- Regular review and re-approval cycle
- Linking SOPs to GLP regulations and study protocols
- Electronic SOP management and access control
- Using SOPs for internal audits and training consistency
Module 12: Data Processing and Transformation - Validated software for data processing in GLP
- Ensuring algorithms and formulas are documented and verified
- Version control for analytical software
- Handling manual data entry into databases
- Change control for data processing systems
- Verification of automated calculations
- Archiving intermediate data and worksheets
- Ensuring traceability from raw data to final report
- Audit trails for data manipulation and export
- Electronic signature requirements for processed data
Module 13: Final Study Report and Documentation - Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Introduction to GLP: Definition, scope, and global relevance
- Historical development of GLP standards and regulatory milestones
- Core principles of Good Laboratory Practice
- Differences between GLP, GMP, and ISO standards
- Understanding the role of OECD GLP principles
- Application of GLP in pharmaceutical, environmental, and chemical testing
- The impact of poor laboratory practice on regulatory approval
- Role of national regulatory bodies in GLP enforcement
- Key terminology and acronyms in GLP compliance
- Understanding the GLP compliance lifecycle
Module 2: Regulatory Frameworks and Global Compliance Requirements - Overview of FDA 21 CFR Part 58 and its requirements
- Understanding EMA GLP guidelines and inspection processes
- ISO/IEC 17025 and its relationship with GLP
- Health Canada’s GLP standards and compliance expectations
- MHRA and OECD GLP compliance in the UK
- GLP requirements in Japan, South Korea, and Asia-Pacific markets
- Differences between regional regulatory expectations
- Preparing for multinational study submissions
- Understanding mutual acceptance of GLP data (MAD)
- Regulatory updates and how to track them proactively
Module 3: Organizational Structure and Personnel Responsibilities - Defining the roles of Study Director, Principal Investigator, and Sponsor
- Training requirements for GLP-compliant staff
- Qualifications and responsibilities of the Quality Assurance Unit (QAU)
- Role of the Test Facility Management in GLP adherence
- Documentation of staff training and competency records
- Handling personnel changes during a study
- Defining responsibilities for data integrity and record-keeping
- Staff supervision and accountability structures
- Developing GLP-specific job descriptions
- Managing third-party contractors under GLP
Module 4: Quality Assurance Unit (QAU) Structure and Functions - Establishing an independent Quality Assurance Unit
- Core responsibilities of the QAU in study oversight
- Developing a Master Schedule of studies
- Creating and managing formal audits and inspections
- Writing and tracking audit findings and corrective actions
- Conducting routine and study-specific QA audits
- Role of QA in raw data verification
- Reporting QA findings to management and study teams
- Ensuring QAU independence and objectivity
- Documenting QA activities and inspection readiness
Module 5: Study Planning and Protocol Development - Elements of a GLP-compliant study protocol
- Defining test and control articles with traceability
- Determining study objectives and acceptance criteria
- Incorporating statistical design in protocol planning
- Pre-approval requirements for protocol finalisation
- Handling protocol amendments and version control
- Obtaining sponsor approval and documenting consent
- Ensuring scientific rigor and regulatory alignment
- Defining test system parameters and monitoring frequency
- Integrating safety and animal welfare considerations
Module 6: Test and Control Article Management - Receipt, identification, and storage of test articles
- Stability and shelf-life monitoring systems
- Preparation and dosing formulation documentation
- Chain of custody for control substances
- Labelling requirements for test articles in compliance
- Handling hazardous materials under GLP
- Inventory tracking systems and audit trails
- Disposal procedures with documented justification
- Sample retention periods and storage conditions
- Re-test schedules and stability protocol alignment
Module 7: Test System Management and Husbandry - Selecting appropriate test systems: rodents, in vitro, etc.
- Animal welfare and ethical oversight requirements
- Facility design for hygiene and environmental control
- Maintaining health monitoring records for animal colonies
- Feeding, bedding, and environmental enrichment standards
- Pre-study acclimatisation and quarantine procedures
- Health surveillance and veterinary care documentation
- Handling unexpected animal health events
- Preventing cross-contamination in multi-study labs
- Documenting procedures for euthanasia and disposal
Module 8: Facility Design and Maintenance - GLP requirements for laboratory physical design
- Separation of clean, contaminated, and waste areas
- Climate control and environmental monitoring logs
- HVAC system validation and maintenance records
- Water, gas, and electrical system documentation
- Security and access control in regulated labs
- Waste handling and decontamination zones
- Emergency preparedness and response planning
- Maintenance logs for laboratory equipment
- Facility inspections and infrastructure audits
Module 9: Equipment Calibration and Maintenance - Establishing a comprehensive equipment inventory
- Calibration schedules based on risk and use frequency
- Documenting calibration results with traceable standards
- Preventive maintenance planning and tracking
- Out-of-calibration investigation and impact assessment
- Equipment logbooks and electronic maintenance records
- Vendor qualification for repair and calibration services
- Requalification after maintenance or relocation
- Temperature mapping for refrigerators and incubators
- Digital calibration management systems
Module 10: Raw Data and Record Management - Definition of raw data in GLP environments
- Acceptable formats: paper, electronic, hybrid systems
- Real-time recording requirements and best practices
- Ensuring data attributable, legible, contemporaneous, original, and accurate (ALCOA+)
- Correcting entries: strike-through, reason, signature, date
- Handling incomplete or missing data entries
- Witnessing and co-signing critical data points
- Storage conditions for paper records
- Retention periods aligned with regulatory expectations
- Audit trail requirements for electronic data systems
Module 11: Standard Operating Procedures (SOPs) - Developing a master list of lab SOPs
- Writing clear, step-by-step, enforceable procedures
- Version control and change management for SOPs
- Approval process involving QA and management
- Ensuring SOPs reflect actual lab practices
- Training staff on new or revised SOPs
- Regular review and re-approval cycle
- Linking SOPs to GLP regulations and study protocols
- Electronic SOP management and access control
- Using SOPs for internal audits and training consistency
Module 12: Data Processing and Transformation - Validated software for data processing in GLP
- Ensuring algorithms and formulas are documented and verified
- Version control for analytical software
- Handling manual data entry into databases
- Change control for data processing systems
- Verification of automated calculations
- Archiving intermediate data and worksheets
- Ensuring traceability from raw data to final report
- Audit trails for data manipulation and export
- Electronic signature requirements for processed data
Module 13: Final Study Report and Documentation - Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Defining the roles of Study Director, Principal Investigator, and Sponsor
- Training requirements for GLP-compliant staff
- Qualifications and responsibilities of the Quality Assurance Unit (QAU)
- Role of the Test Facility Management in GLP adherence
- Documentation of staff training and competency records
- Handling personnel changes during a study
- Defining responsibilities for data integrity and record-keeping
- Staff supervision and accountability structures
- Developing GLP-specific job descriptions
- Managing third-party contractors under GLP
Module 4: Quality Assurance Unit (QAU) Structure and Functions - Establishing an independent Quality Assurance Unit
- Core responsibilities of the QAU in study oversight
- Developing a Master Schedule of studies
- Creating and managing formal audits and inspections
- Writing and tracking audit findings and corrective actions
- Conducting routine and study-specific QA audits
- Role of QA in raw data verification
- Reporting QA findings to management and study teams
- Ensuring QAU independence and objectivity
- Documenting QA activities and inspection readiness
Module 5: Study Planning and Protocol Development - Elements of a GLP-compliant study protocol
- Defining test and control articles with traceability
- Determining study objectives and acceptance criteria
- Incorporating statistical design in protocol planning
- Pre-approval requirements for protocol finalisation
- Handling protocol amendments and version control
- Obtaining sponsor approval and documenting consent
- Ensuring scientific rigor and regulatory alignment
- Defining test system parameters and monitoring frequency
- Integrating safety and animal welfare considerations
Module 6: Test and Control Article Management - Receipt, identification, and storage of test articles
- Stability and shelf-life monitoring systems
- Preparation and dosing formulation documentation
- Chain of custody for control substances
- Labelling requirements for test articles in compliance
- Handling hazardous materials under GLP
- Inventory tracking systems and audit trails
- Disposal procedures with documented justification
- Sample retention periods and storage conditions
- Re-test schedules and stability protocol alignment
Module 7: Test System Management and Husbandry - Selecting appropriate test systems: rodents, in vitro, etc.
- Animal welfare and ethical oversight requirements
- Facility design for hygiene and environmental control
- Maintaining health monitoring records for animal colonies
- Feeding, bedding, and environmental enrichment standards
- Pre-study acclimatisation and quarantine procedures
- Health surveillance and veterinary care documentation
- Handling unexpected animal health events
- Preventing cross-contamination in multi-study labs
- Documenting procedures for euthanasia and disposal
Module 8: Facility Design and Maintenance - GLP requirements for laboratory physical design
- Separation of clean, contaminated, and waste areas
- Climate control and environmental monitoring logs
- HVAC system validation and maintenance records
- Water, gas, and electrical system documentation
- Security and access control in regulated labs
- Waste handling and decontamination zones
- Emergency preparedness and response planning
- Maintenance logs for laboratory equipment
- Facility inspections and infrastructure audits
Module 9: Equipment Calibration and Maintenance - Establishing a comprehensive equipment inventory
- Calibration schedules based on risk and use frequency
- Documenting calibration results with traceable standards
- Preventive maintenance planning and tracking
- Out-of-calibration investigation and impact assessment
- Equipment logbooks and electronic maintenance records
- Vendor qualification for repair and calibration services
- Requalification after maintenance or relocation
- Temperature mapping for refrigerators and incubators
- Digital calibration management systems
Module 10: Raw Data and Record Management - Definition of raw data in GLP environments
- Acceptable formats: paper, electronic, hybrid systems
- Real-time recording requirements and best practices
- Ensuring data attributable, legible, contemporaneous, original, and accurate (ALCOA+)
- Correcting entries: strike-through, reason, signature, date
- Handling incomplete or missing data entries
- Witnessing and co-signing critical data points
- Storage conditions for paper records
- Retention periods aligned with regulatory expectations
- Audit trail requirements for electronic data systems
Module 11: Standard Operating Procedures (SOPs) - Developing a master list of lab SOPs
- Writing clear, step-by-step, enforceable procedures
- Version control and change management for SOPs
- Approval process involving QA and management
- Ensuring SOPs reflect actual lab practices
- Training staff on new or revised SOPs
- Regular review and re-approval cycle
- Linking SOPs to GLP regulations and study protocols
- Electronic SOP management and access control
- Using SOPs for internal audits and training consistency
Module 12: Data Processing and Transformation - Validated software for data processing in GLP
- Ensuring algorithms and formulas are documented and verified
- Version control for analytical software
- Handling manual data entry into databases
- Change control for data processing systems
- Verification of automated calculations
- Archiving intermediate data and worksheets
- Ensuring traceability from raw data to final report
- Audit trails for data manipulation and export
- Electronic signature requirements for processed data
Module 13: Final Study Report and Documentation - Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Elements of a GLP-compliant study protocol
- Defining test and control articles with traceability
- Determining study objectives and acceptance criteria
- Incorporating statistical design in protocol planning
- Pre-approval requirements for protocol finalisation
- Handling protocol amendments and version control
- Obtaining sponsor approval and documenting consent
- Ensuring scientific rigor and regulatory alignment
- Defining test system parameters and monitoring frequency
- Integrating safety and animal welfare considerations
Module 6: Test and Control Article Management - Receipt, identification, and storage of test articles
- Stability and shelf-life monitoring systems
- Preparation and dosing formulation documentation
- Chain of custody for control substances
- Labelling requirements for test articles in compliance
- Handling hazardous materials under GLP
- Inventory tracking systems and audit trails
- Disposal procedures with documented justification
- Sample retention periods and storage conditions
- Re-test schedules and stability protocol alignment
Module 7: Test System Management and Husbandry - Selecting appropriate test systems: rodents, in vitro, etc.
- Animal welfare and ethical oversight requirements
- Facility design for hygiene and environmental control
- Maintaining health monitoring records for animal colonies
- Feeding, bedding, and environmental enrichment standards
- Pre-study acclimatisation and quarantine procedures
- Health surveillance and veterinary care documentation
- Handling unexpected animal health events
- Preventing cross-contamination in multi-study labs
- Documenting procedures for euthanasia and disposal
Module 8: Facility Design and Maintenance - GLP requirements for laboratory physical design
- Separation of clean, contaminated, and waste areas
- Climate control and environmental monitoring logs
- HVAC system validation and maintenance records
- Water, gas, and electrical system documentation
- Security and access control in regulated labs
- Waste handling and decontamination zones
- Emergency preparedness and response planning
- Maintenance logs for laboratory equipment
- Facility inspections and infrastructure audits
Module 9: Equipment Calibration and Maintenance - Establishing a comprehensive equipment inventory
- Calibration schedules based on risk and use frequency
- Documenting calibration results with traceable standards
- Preventive maintenance planning and tracking
- Out-of-calibration investigation and impact assessment
- Equipment logbooks and electronic maintenance records
- Vendor qualification for repair and calibration services
- Requalification after maintenance or relocation
- Temperature mapping for refrigerators and incubators
- Digital calibration management systems
Module 10: Raw Data and Record Management - Definition of raw data in GLP environments
- Acceptable formats: paper, electronic, hybrid systems
- Real-time recording requirements and best practices
- Ensuring data attributable, legible, contemporaneous, original, and accurate (ALCOA+)
- Correcting entries: strike-through, reason, signature, date
- Handling incomplete or missing data entries
- Witnessing and co-signing critical data points
- Storage conditions for paper records
- Retention periods aligned with regulatory expectations
- Audit trail requirements for electronic data systems
Module 11: Standard Operating Procedures (SOPs) - Developing a master list of lab SOPs
- Writing clear, step-by-step, enforceable procedures
- Version control and change management for SOPs
- Approval process involving QA and management
- Ensuring SOPs reflect actual lab practices
- Training staff on new or revised SOPs
- Regular review and re-approval cycle
- Linking SOPs to GLP regulations and study protocols
- Electronic SOP management and access control
- Using SOPs for internal audits and training consistency
Module 12: Data Processing and Transformation - Validated software for data processing in GLP
- Ensuring algorithms and formulas are documented and verified
- Version control for analytical software
- Handling manual data entry into databases
- Change control for data processing systems
- Verification of automated calculations
- Archiving intermediate data and worksheets
- Ensuring traceability from raw data to final report
- Audit trails for data manipulation and export
- Electronic signature requirements for processed data
Module 13: Final Study Report and Documentation - Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Selecting appropriate test systems: rodents, in vitro, etc.
- Animal welfare and ethical oversight requirements
- Facility design for hygiene and environmental control
- Maintaining health monitoring records for animal colonies
- Feeding, bedding, and environmental enrichment standards
- Pre-study acclimatisation and quarantine procedures
- Health surveillance and veterinary care documentation
- Handling unexpected animal health events
- Preventing cross-contamination in multi-study labs
- Documenting procedures for euthanasia and disposal
Module 8: Facility Design and Maintenance - GLP requirements for laboratory physical design
- Separation of clean, contaminated, and waste areas
- Climate control and environmental monitoring logs
- HVAC system validation and maintenance records
- Water, gas, and electrical system documentation
- Security and access control in regulated labs
- Waste handling and decontamination zones
- Emergency preparedness and response planning
- Maintenance logs for laboratory equipment
- Facility inspections and infrastructure audits
Module 9: Equipment Calibration and Maintenance - Establishing a comprehensive equipment inventory
- Calibration schedules based on risk and use frequency
- Documenting calibration results with traceable standards
- Preventive maintenance planning and tracking
- Out-of-calibration investigation and impact assessment
- Equipment logbooks and electronic maintenance records
- Vendor qualification for repair and calibration services
- Requalification after maintenance or relocation
- Temperature mapping for refrigerators and incubators
- Digital calibration management systems
Module 10: Raw Data and Record Management - Definition of raw data in GLP environments
- Acceptable formats: paper, electronic, hybrid systems
- Real-time recording requirements and best practices
- Ensuring data attributable, legible, contemporaneous, original, and accurate (ALCOA+)
- Correcting entries: strike-through, reason, signature, date
- Handling incomplete or missing data entries
- Witnessing and co-signing critical data points
- Storage conditions for paper records
- Retention periods aligned with regulatory expectations
- Audit trail requirements for electronic data systems
Module 11: Standard Operating Procedures (SOPs) - Developing a master list of lab SOPs
- Writing clear, step-by-step, enforceable procedures
- Version control and change management for SOPs
- Approval process involving QA and management
- Ensuring SOPs reflect actual lab practices
- Training staff on new or revised SOPs
- Regular review and re-approval cycle
- Linking SOPs to GLP regulations and study protocols
- Electronic SOP management and access control
- Using SOPs for internal audits and training consistency
Module 12: Data Processing and Transformation - Validated software for data processing in GLP
- Ensuring algorithms and formulas are documented and verified
- Version control for analytical software
- Handling manual data entry into databases
- Change control for data processing systems
- Verification of automated calculations
- Archiving intermediate data and worksheets
- Ensuring traceability from raw data to final report
- Audit trails for data manipulation and export
- Electronic signature requirements for processed data
Module 13: Final Study Report and Documentation - Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Establishing a comprehensive equipment inventory
- Calibration schedules based on risk and use frequency
- Documenting calibration results with traceable standards
- Preventive maintenance planning and tracking
- Out-of-calibration investigation and impact assessment
- Equipment logbooks and electronic maintenance records
- Vendor qualification for repair and calibration services
- Requalification after maintenance or relocation
- Temperature mapping for refrigerators and incubators
- Digital calibration management systems
Module 10: Raw Data and Record Management - Definition of raw data in GLP environments
- Acceptable formats: paper, electronic, hybrid systems
- Real-time recording requirements and best practices
- Ensuring data attributable, legible, contemporaneous, original, and accurate (ALCOA+)
- Correcting entries: strike-through, reason, signature, date
- Handling incomplete or missing data entries
- Witnessing and co-signing critical data points
- Storage conditions for paper records
- Retention periods aligned with regulatory expectations
- Audit trail requirements for electronic data systems
Module 11: Standard Operating Procedures (SOPs) - Developing a master list of lab SOPs
- Writing clear, step-by-step, enforceable procedures
- Version control and change management for SOPs
- Approval process involving QA and management
- Ensuring SOPs reflect actual lab practices
- Training staff on new or revised SOPs
- Regular review and re-approval cycle
- Linking SOPs to GLP regulations and study protocols
- Electronic SOP management and access control
- Using SOPs for internal audits and training consistency
Module 12: Data Processing and Transformation - Validated software for data processing in GLP
- Ensuring algorithms and formulas are documented and verified
- Version control for analytical software
- Handling manual data entry into databases
- Change control for data processing systems
- Verification of automated calculations
- Archiving intermediate data and worksheets
- Ensuring traceability from raw data to final report
- Audit trails for data manipulation and export
- Electronic signature requirements for processed data
Module 13: Final Study Report and Documentation - Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Developing a master list of lab SOPs
- Writing clear, step-by-step, enforceable procedures
- Version control and change management for SOPs
- Approval process involving QA and management
- Ensuring SOPs reflect actual lab practices
- Training staff on new or revised SOPs
- Regular review and re-approval cycle
- Linking SOPs to GLP regulations and study protocols
- Electronic SOP management and access control
- Using SOPs for internal audits and training consistency
Module 12: Data Processing and Transformation - Validated software for data processing in GLP
- Ensuring algorithms and formulas are documented and verified
- Version control for analytical software
- Handling manual data entry into databases
- Change control for data processing systems
- Verification of automated calculations
- Archiving intermediate data and worksheets
- Ensuring traceability from raw data to final report
- Audit trails for data manipulation and export
- Electronic signature requirements for processed data
Module 13: Final Study Report and Documentation - Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Structure of a GLP-compliant final report
- Required sections: summary, materials, methods, results
- Incorporating raw data, appendices, and deviations
- Study Director’s statement of compliance
- QA certification of the final report
- Signature and dating requirements
- Version control and final approval process
- Submitting the report to regulatory authorities
- Handling report amendments post-submission
- Maintaining inspection trail from protocol to report
Module 14: Archiving and Record Retention - Defining records that must be archived under GLP
- Retention periods for different study types and regulations
- Selecting secure, access-controlled archive locations
- Indexing and cataloguing archived studies
- Fire protection, environmental control, and backup systems
- Digital archiving: media integrity and format longevity
- Retrieval procedures for inspections or audits
- Documenting transfers between archive facilities
- Third-party archive vendor qualification and audits
- Disposal authorisations after retention period expires
Module 15: Deviation and Non-Conformance Management - Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Defining deviations, non-conformances, and critical incidents
- Immediate actions and containment procedures
- Root cause analysis using fishbone and 5-why methods
- Drafting formal deviation reports with evidence
- Evaluating impact on study integrity and data validity
- Approval workflow involving QA and management
- Implementing corrective and preventive actions (CAPA)
- Tracking CAPA effectiveness over time
- Reporting significant deviations to regulators when required
- Using deviations for continuous improvement
Module 16: Computerised Systems and Electronic Records - Regulatory expectations for electronic systems under 21 CFR Part 11
- User access levels and role-based permissions
- Creating and maintaining system validation protocols
- Electronic signatures: requirements and implementation
- Data backup, recovery, and disaster planning
- Audit trail review frequency and methodology
- Change control for software updates and upgrades
- Vendor qualification for software providers
- Managing hybrid systems with paper and electronic records
- Cybersecurity considerations in regulated environments
Module 17: Audit Preparation and Mock Inspections - Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Planning a full regulatory readiness assessment
- Conducting internal mock inspections
- Preparing staff for inspector interviews
- Organising physical and digital inspection files
- Common inspection triggers and how to anticipate them
- Handling inspector requests professionally
- Developing an inspection response team
- Role-playing challenging audit scenarios
- Reviewing past inspection reports for recurring issues
- Final pre-audit checklist and walk-through
Module 18: Handling Regulatory Inspections - Opening meeting expectations and procedures
- Accompanying inspectors: dos and don'ts
- Handling document requests calmly and efficiently
- Responding to verbal observations and clarifications
- Managing areas of concern without admitting fault
- Closing meeting best practices
- Documenting inspector comments and follow-up actions
- Internal debriefing after inspection conclusion
- Preserving inspection integrity under pressure
- Maintaining professionalism throughout
Module 19: Post-Inspection Response and Corrective Actions - Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Analysing inspection reports and observations
- Distinguishing between critical, major, and minor findings
- Developing formal responses with evidence and timelines
- Submitting written responses to regulatory authorities
- Implementing CAPA with measurable outcomes
- Re-audit preparation and evidence submission
- Maintaining ongoing communication with inspectors
- Using inspection findings for systemic improvement
- Training teams on repeat issues
- Tracking closure of each observation
Module 20: GLP in Non-Clinical Toxicology Studies - Study types: acute, sub-chronic, chronic toxicity
- Design-specific GLP requirements
- Handling test systems and dosing regimens
- Pathology and histopathology documentation
- Biological sample collection and processing
- Data collection frequency and parameters
- Peer review of pathology findings
- Reporting adverse events and mortality
- Integrating biomonitoring with GLP
- Auditing toxicology study data integrity
Module 21: GLP in Environmental and Ecotoxicology Studies - Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Study types: aquatic, terrestrial, sediment toxicity
- Defining test organisms and environmental relevance
- Monitoring environmental parameters continuously
- Calibrating sensors and data loggers
- Ensuring water quality and temperature stability
- Handling effluents and waste safely
- Documenting batch numbers and media preparation
- Incorporating weather data in field studies
- Reporting ecological impact with scientific rigour
- Aligning with OECD Test Guidelines
Module 22: GLP for Analytical Chemistry and Testing - Method validation under GLP: specificity, accuracy, precision
- Establishing calibration curves and control samples
- Handling blanks, positives, negatives in analysis
- Instrument qualification: DQ, IQ, OQ, PQ
- System suitability testing frequency
- Chain of custody for samples
- Sample coding and blinding procedures
- Reporting limits of detection and quantification
- Handling out-of-specification (OOS) results
- Auditing analytical raw data and chromatograms
Module 23: Cross-Functional Collaboration and Communication - Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Aligning GLP expectations across departments
- Communicating deviations to non-GLP teams
- Working with procurement on compliant supplies
- Coordinating with IT on system validations
- Engaging EH&S on hazardous material handling
- Reporting timelines to project management
- Creating interdepartmental SOPs
- Holding compliance alignment meetings
- Using shared dashboards for transparency
- Resolving conflicts between speed and compliance
Module 24: Career Advancement Through GLP Mastery - Positioning your GLP expertise in performance reviews
- Crafting your resume with compliance leadership language
- Using your certificate to apply for senior roles
- Transitioning from technician to QA or Study Director
- Networking within regulatory and compliance associations
- Speaking at industry events on GLP implementation
- Documenting ROI of compliance improvements
- Becoming a go-to resource in your organisation
- Preparing for interviews in regulated environments
- Building a professional brand as a GLP authority
Module 25: Certification, Final Assessment, and Next Steps - Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service
- Comprehensive assessment: real-world compliance scenarios
- Evaluating mastery of SOP writing, deviation response, audit prep
- Submitting a full mock inspection readiness package
- Receiving personalised feedback from GLP experts
- Reviewing model answers and best practice solutions
- Finalising your professional development plan
- Downloading your Certificate of Completion
- Sharing your achievement via LinkedIn and portfolios
- Accessing post-course resources and updates
- Joining the global alumni network of The Art of Service