Training Agenda
Good Laboratory Practice (GLP) Training Agenda
Day 1: GLP Fundamentals, Regulatory Framework & Laboratory Quality Systems
Build a strong foundation in GLP requirements, laboratory organization, facilities, SOPs, and test article controls.
Session 1: Introduction to Good Laboratory Practice (GLP)
- Evolution and history of GLP
- Purpose and objectives of GLP
- FDA 21 CFR Part 58 requirements
- OECD Principles of GLP
- EPA GLP requirements
- International harmonization of GLP
- GLP versus GMP, GCP, and ISO/IEC 17025
- Regulatory expectations for nonclinical laboratories
Session 2: Organization, Personnel & Management Responsibilities
- Test Facility Management responsibilities
- Study Director responsibilities
- Principal Investigator responsibilities
- Quality Assurance Unit (QAU)
- Personnel qualifications and competency
- Training programs
- Delegation of responsibilities
- Organizational structure under GLP
- Resource planning
Session 3: GLP Facilities, Equipment & Laboratory Operations
- Laboratory design and layout
- Environmental controls
- Equipment qualification
- Calibration programs
- Preventive maintenance
- Computerized laboratory systems
- Laboratory utilities
- Facility inspections
- Material segregation
Session 4: Standard Operating Procedures (SOPs)
- Developing effective SOPs
- SOP approval process
- Revision control
- SOP training
- Document management
- Controlled documentation
- Deviations from SOPs
- Periodic review requirements
Session 5: Test & Control Articles
- Characterization requirements
- Receipt and storage
- Labeling
- Distribution
- Sample accountability
- Stability considerations
- Chain of custody
- Retention requirements
Day 2: Conducting GLP Studies & Data Integrity
Learn how to plan, conduct, document, validate, and manage GLP studies and laboratory data.
Session 6: Study Planning & Protocol Development
- Study protocols
- Amendments
- Study initiation
- Scheduling
- Master schedule
- Protocol deviations
- Sponsor interactions
- Study documentation
- Multi-site studies
Session 7: Conduct of Nonclinical Laboratory Studies
- Sample handling
- Laboratory testing
- Analytical procedures
- Method validation
- Animal studies
- Test systems
- Environmental monitoring
- Documentation requirements
- Recording observations
Session 8: Data Integrity & Electronic Records
- ALCOA+ principles
- Raw data management
- Electronic records
- Electronic signatures
- Audit trails
- Data review
- Metadata
- Backup and recovery
- Cybersecurity considerations
Session 9: Computerized Systems in GLP Laboratories
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- Laboratory Information Management Systems (LIMS)
- Electronic Laboratory Notebooks (ELN)
- Instrument software validation
- Vendor assessment
- Cloud-based laboratory systems
- AI applications in laboratories
Session 10: Documentation & Record Management
- Raw data
- Laboratory notebooks
- Corrections and amendments
- Record retention
- Archiving requirements
- Electronic archives
- Retrieval procedures
- Confidentiality requirements
Day 3: Quality Assurance, Audits & Inspection Readiness
Prepare for GLP audits, inspections, CAPA, quality oversight, and sustainable compliance.
Session 11: Quality Assurance Unit (QAU)
- QAU responsibilities
- Facility inspections
- Process inspections
- Study audits
- Data audits
- Final report audits
- Audit reporting
- Follow-up activities
Session 12: Deviations, CAPA & Risk Management
- Managing deviations
- Root Cause Analysis (RCA)
- Corrective and Preventive Actions (CAPA)
- Risk assessment
- Change management
- Trending
- Continuous improvement
- Quality metrics
Session 13: FDA & OECD GLP Inspections
- Inspection process
- Preparing for inspections
- Inspector expectations
- Documentation review
- Interview preparation
- Facility walkthrough
- Responding to inspection findings
- FDA Form 483 observations
- Warning Letters
Session 14: GLP Compliance Challenges & Best Practices
- Outsourced laboratories
- CRO oversight
- Sponsor responsibilities
- Laboratory modernization
- Digital transformation
- Remote monitoring
- Global regulatory expectations
- Common compliance pitfalls
- Best practices for sustained compliance
Session 15: Building a Sustainable GLP Compliance Program
- GLP compliance roadmap
- Management review
- Quality culture
- Performance indicators
- Inspection readiness program
- Continuous improvement
- Future trends in GLP
- Emerging technologies
- Open discussion and Q&A
Hands-On Workshops Included
Good Laboratory Practice (GLP nonclinical) Online Training Course Description
This Good Laboratory Practice (GLP) nonclinical training course introduces learners to the general requirements for the competence of testing and calibration laboratories as outlined in ISO/IEC 17025:2017.
Topics you’ll learn about in this course include:
- The importance of impartiality and confidentiality
- Laboratory organisation and management structure
- Resources – personnel, facilities, environment and equipment
- Metrological traceability
- Test methods and method validation
- Sampling plan and sampling method
- Evaluation of measurement uncertainty
- Technical records
- Test results and reporting
- Complaints and nonconformance handling
- Management system – documentation, corrective actions, internal audits and management reviews
This Good Laboratory Practice (GLP) training course is designed to suit individuals looking to understand the principles of GLP, and GLP compliance requirements, in non-clinical laboratories.
Learn to comply with GLP rules with online training
- The GLP training course, available completely online, delves into how the concept of good laboratory practice came into effect as a regulatory standard.
- It provides helpful information on documents published to ensure GLP compliance is well understood and followed worldwide, including internal GLP Audit checklists for GMP compliance monitoring.
- It includes GLP case studies to help explain the importance of compliance with GLP principles.
- It is an excellent resource for a blending training experience for laboratory personnel, as an initiation course and as a GLP refresher course.
GLP Case Studies and Checklists
These case studies, along with the information and Good Laboratory Practice (GLP) checklists provided in this GLP certification course online, can help laboratory organisations (including University Laboratories) identify potential GLP gaps within their laboratory facilities, research teams, and/or their laboratory research/testing processes (e.g. their standard operating procedures/SOPs).
OECD’s Principles of GLP
- GLP training courses are imperative for individuals and research institutions/organisations with laboratory operations.
- This Good Laboratory Practice (GLP) training course will introduce learners to the OECD Principles of GLP.
- These principles were compiled by the OECD (Organisation for Economic Co-operation and Development) to ensure the generation of high quality and reliable test data by laboratories conducting non-clinical studies.
- These principles are used to regulate laboratories in Australia and many other countries.
Why is understanding compliance requirements for Good Laboratory Practice (GLP) crucial for laboratory teams and other relevant personnel?
Complying with OECD GLP principles is are an imperative step for future drug development applications to regulatory authorities, such as the FDA, TGA, EMA, MHRA, NMA, AMA and other regulatory authorities who review new drug applications/marketing authority applications.
This course is an excellent laboratory personnel training resource. Completing this course will help learners and companies prepare for laboratory accreditation (e.g., as GLP training as a component of accreditation requirements for testing and calibration laboratories in Australia).
Who Will Benefit
This course is intended for all industries developing products that require FDA approval for research or marketing including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. It will be beneficial to anyone planning, conducting, monitoring, managing, supervising, or otherwise supporting non-clinical studies. This program is especially valuable for onboarding any employee involved directly or indirectly in nonclinical study planning and execution, to ensure alignment on GLP culture and fundamentals within your organization prior to engaging in work that impacts GLP compliance.
- Laboratory personnel involved in non-clinical studies
- Quality assurance and quality control professionals
- Regulatory affairs specialists
- Study director
- Facility management
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Archivists
Know Your Faculty
Course Speaker
Faculty
Kelly Thomas
Kelly Thomas is a seasoned Quality Assurance and Regulatory Compliance expert with over 30 years of experience in the pharmaceutical, biotechnology, API, and medical device industries. Her expertise includes FDA cGMP compliance, Quality Management Systems (QMS), process validation, technology transfer, supplier quality management, regulatory inspections, and global quality systems.
Kelly has successfully led FDA, EMA, Health Canada, ANVISA, and other international regulatory inspections, supporting API, biologics, sterile injectable, oral solid dosage (OSD), medical device, and combination product manufacturing. She is recognized for strengthening quality systems, driving inspection readiness, implementing Lean Six Sigma initiatives, and helping organizations achieve regulatory compliance while ensuring product quality and patient safety.
