Overview
Good Laboratory Practice (GLP) training is essential for professionals working in nonclinical laboratory settings that support regulatory submissions. GLP is a quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. The importance of implementing Good Laboratory Practices is to ensure quality in test data, good management of quality, reliability, the integrity of studies, and traceability of data. This guide explores new GLP training programs with certificates that help professionals meet regulatory requirements and advance their careers.
https://www.gxptrainings.com/course-category/glp-training
What Is GLP Training?
GLP training provides professionals with the knowledge and skills needed to conduct nonclinical laboratory studies in compliance with regulatory requirements. The training covers the principles of GLP as defined by the FDA in 21 CFR Part 58 and the OECD GLP principles.
Quality System Focus – GLP is a quality system that ensures the reliability and integrity of nonclinical study data. Training helps professionals understand and implement this system.
Regulatory Compliance – GLP training ensures that laboratories meet the requirements of regulatory authorities, including the FDA, EPA, and international agencies.
Data Integrity – A core component of GLP is ensuring that data are accurate, complete, and traceable. Training covers the principles of data integrity in the laboratory.
What Does GLP Training Cover?
GLP training typically covers the full scope of GLP requirements, including organizational structure, personnel qualifications, facility requirements, equipment management, and study conduct. The OECD GLP course, for example, is divided into modules covering the importance of the quality system, an in-depth study of the GLP principles, and references to the Mutual Acceptance of Data agreement.
Organization and Personnel – Understanding the roles and responsibilities of test facility management, study directors, quality assurance personnel, and study staff is fundamental to GLP compliance.
Quality Assurance Programme – The Quality Assurance (QA) program is a cornerstone of GLP. Training covers the role of QA in monitoring studies, conducting inspections, and ensuring compliance.
Facilities and Equipment – GLP requires appropriate facilities and equipment for conducting studies. Training covers facility design, environmental conditions, and equipment qualification.
Study Conduct and Reporting – GLP training covers the conduct of nonclinical studies from protocol development through final reporting. This includes documentation, record-keeping, and archiving requirements.
Who Should Take GLP Training?
GLP training is designed for a wide range of professionals involved in nonclinical laboratory studies. The target audience includes laboratory managers, supervisors, quality assurance personnel, study directors, and technical staff.
Laboratory Professionals – Analysts, technicians, and supervisors who work in nonclinical testing laboratories require GLP training to understand their responsibilities and perform their duties in compliance with GLP regulations.
Quality Assurance Personnel – QA professionals need GLP training to effectively monitor studies and conduct inspections.
Study Directors – Individuals responsible for the overall conduct of nonclinical studies must have comprehensive GLP training.
Regulatory Affairs Professionals – Those involved in regulatory submissions need to understand GLP requirements to ensure that studies meet regulatory expectations.
Certification Benefits
GLP certification provides several benefits for professionals and organizations. Upon successful completion of GLP training, participants typically receive a certificate that demonstrates their understanding of GLP principles.
Career Advancement – GLP certification demonstrates competence and commitment to quality, enhancing career prospects in pharmaceutical and laboratory settings.
Regulatory Compliance – Certification provides documented evidence of training for regulatory inspections.
Professional Credibility – Certification establishes the individual as a knowledgeable professional in laboratory compliance.
Detailed Course Breakdown
Course 1: Good Laboratory Practices (FDA Focused)
This comprehensive training program provides comprehensive instruction on the U.S. Food and Drug Administration’s Good Laboratory Practice (GLP) regulations, codified as 21 Code of Federal Regulations (CFR) Part 58. The program transforms regulatory requirements into practical knowledge applicable to nonclinical laboratory operations.
Scope: The program begins with the historical context that led to the establishment of GLP regulations, a period marked by significant data integrity failures that undermined public trust and the scientific process. From this foundation, the program systematically builds knowledge across the entire lifecycle of a nonclinical laboratory study, covering organizational structure, facility design, equipment management, standard operating procedures, test article handling, protocol development, study conduct, data management, quality assurance, reporting, and enforcement consequences.
Description of Modules: The curriculum covers:
- Historical Context – the events leading to the establishment of GLP regulations
- Regulatory Requirements – in-depth coverage of 21 CFR Part 58
- Organization and Personnel – roles and responsibilities in a GLP-compliant laboratory
- Quality Assurance Programme – monitoring, inspections, and compliance verification
- Facilities and Environmental Conditions – requirements for GLP-compliant facilities
- Equipment Management – qualification, calibration, and maintenance requirements
- Test and Control Articles – handling, characterization, and storage
- Protocol and Conduct of Studies – planning, execution, and documentation
- Records and Reports – documentation, record-keeping, and archiving
- Data Integrity and regulatory compliance
- Enforcement Consequences – regulatory actions for non-compliance
Target Audience:
- Study Directors and Principal Investigators
- Quality Assurance Personnel
- Scientific and Technical Staff
- Testing Facility Management
- Sponsor Organizations
- Regulatory Affairs Professionals
- Auditors and Inspectors
Pricing: $149.00 with group discounts available.
FAQ:
- What is GLP training? GLP training provides professionals with the knowledge and skills needed to conduct nonclinical laboratory studies in compliance with regulatory requirements, including 21 CFR Part 58 and OECD GLP principles.
- What is the difference between GLP and GMP? GLP applies to nonclinical laboratory studies that support regulatory submissions, while GMP applies to the manufacturing of pharmaceutical products.
- What is the role of the Quality Assurance Unit in GLP? The Quality Assurance Unit is responsible for monitoring studies, conducting inspections, and ensuring compliance with GLP regulations.
- What are the benefits of GLP certification? GLP certification demonstrates competence and commitment to quality, enhancing career prospects and providing documented evidence of training for regulatory inspections.
- What are the consequences of GLP non-compliance? Non-compliance can lead to regulatory actions, including rejection of study data, warning letters, fines, and legal action.
Enroll Now: https://www.gxptrainings.com/courses/good-laboratory-practice-glp-training-program/
Course 2: Good Laboratory Practices (OECD Focused)
This comprehensive training program offers an in-depth examination of the OECD Principles of Good Laboratory Practice (GLP) , as revised in 1997. Tailored for professionals in the pharmaceutical, chemical, and biotechnology sectors, the curriculum addresses the complete range of GLP requirements.
Scope: The program covers organizational responsibilities, quality assurance, study conduct, data integrity, and archival management. It equips participants with practical knowledge of how GLP facilitates the production of reliable, reproducible, and internationally recognized non-clinical safety data, thereby supporting regulatory compliance, safeguarding human health, and enabling the Mutual Acceptance of Data (MAD) in global markets.
Description of Modules: The curriculum covers 12 comprehensive sections:
- Test Facility Organisation and Personnel – responsibilities of management, Study Director, Principal Investigator, and study personnel
- Quality Assurance Programme – independence, inspections, and QA statement in final report
- Facilities – general requirements, test system facilities, archive facilities, waste disposal
- Apparatus, Material and Reagents – design, calibration, maintenance, labelling, expiry date management
- Test Systems – physical/chemical and biological systems
- Test and Reference Items – receipt, handling, sampling, storage, characterisation
- Standard Operating Procedures – availability, approval, deviations, historical file
- Performance of the Study – study plan, amendments, deviations, conduct, raw data recording
- Reporting of Study Results – final report content, QA statement, Study Director signature
- Storage and Retention of Records and Materials – archives, retention periods, indexing
- Multi-Site Study Management – Principal Investigator role, communication, master schedule
- Mutual Acceptance of Data (MAD) and international regulatory recognition
Target Audience:
- Laboratory Technicians and Study Personnel
- Study Directors and Principal Investigators
- Quality Assurance (QA) Professionals
- Test Facility and Test Site Management
- Regulatory Affairs Specialists
- Sponsors
- New Employees requiring GLP orientation
Pricing: $149.00 with group discounts available.
FAQ:
- What is the Mutual Acceptance of Data (MAD) agreement? The MAD agreement allows test data generated in one OECD member country to be accepted by other member countries, reducing the need for duplicate testing.
- What are the OECD Principles of GLP? The OECD GLP principles are international standards for quality and validity of nonclinical safety data, as revised in 1997.
- What is the role of the Principal Investigator in multi-site studies? The Principal Investigator is responsible for delegated phases of multi-site studies and must understand their compliance obligations.
- What is the OECD Series on Principles of GLP? The OECD Series provides guidance on GLP principles and compliance monitoring, with Number 1 covering the core principles.
- How do OECD GLP principles relate to FDA regulations? The OECD GLP principles are consistent with and inform FDA’s 21 CFR Part 58, enabling international recognition of study data.
Enroll Now: https://www.gxptrainings.com/courses/oecd-good-laboratory-practice-glp/
Course 3: GLP Internal Auditor Certification (FDA Focused)
This self-study training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in 21 CFR Part 58. The program integrates GLP requirements for nonclinical laboratory studies with internal auditing practices based on ISO 19011.
Scope: The participant learns both what GLP requires and how to plan, execute, report, and close internal audits of those requirements. The program is designed for internal auditing only and does not qualify individuals for FDA or other regulatory inspections.
Description of Modules: The curriculum covers operational areas including:
- Facilities – animal care areas, animal supply areas, test and control article handling areas, laboratory operation areas, specimen and data storage facilities
- Equipment – design, maintenance, calibration, and inspection requirements
- Testing facility operations – standard operating procedures, reagents and solutions, animal care
- Test and control articles – characterization, handling, and mixtures with carriers
- Protocol and conduct of studies – protocol approval, changes, and study conduct
- Records and reports – final reporting, storage and retrieval, retention requirements
- Quality assurance unit – responsibilities, inspections, reporting, independence from study conduct
- Personnel and management – training, job descriptions, study director responsibilities, management obligations
- Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non-conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure
Target Audience:
- Quality Assurance Unit Personnel
- Internal Auditors (both existing and prospective)
- Study Directors
- Testing Facility Management
- Archivists
- Laboratory Supervisors
- Sponsor Representatives
Prerequisites: Completion of basic GLP awareness training of at least four hours or equivalent on-the-job experience; at least six months of experience in a nonclinical laboratory testing facility; basic computer skills using Excel and Word.
Pricing: $599.00 with group discounts available.
FAQ:
- What is the difference between the FDA-focused and OECD-focused GLP auditor certifications? The FDA-focused certification covers 21 CFR Part 58, while the OECD-focused certification covers the OECD Principles of GLP, which are internationally recognized.
- What are the prerequisites for the GLP Internal Auditor Certification? Completion of basic GLP awareness training and at least six months of experience in a nonclinical laboratory testing facility.
- What is ISO 19011 and why is it important for auditors? ISO 19011 provides guidelines for auditing management systems, covering audit principles, programme management, conduct, and competence evaluation.
- What are the seven quality management principles in GLP? The principles include integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach.
- Can I conduct regulatory inspections with this certification? No, the program is designed for internal auditing only and does not qualify individuals for FDA or other regulatory inspections.
Enroll Now: https://www.gxptrainings.com/courses/glp-internal-certified-auditor/
Course 4: GLP Internal Auditor Certification (OECD Focused)
This training program defines the complete knowledge and performance requirements for personnel within a nonclinical laboratory testing facility to become certified internal auditors for Good Laboratory Practice (GLP) as prescribed in the OECD Principles of Good Laboratory Practice (as revised in 1997). The program integrates GLP requirements for single-site and multi-site studies with internal auditing practices based on ISO 19011.
Scope: The participant learns both what the OECD GLP requires and how to plan, execute, report on, and close internal audits of those requirements. The program is designed for internal auditing only and does not qualify individuals for inspections by the national GLP compliance monitoring authority.
Description of Modules: The curriculum covers:
- Test Facility Organisation and Personnel – test facility management responsibilities, Study Director responsibilities, Principal Investigator responsibilities, study personnel responsibilities
- Quality Assurance Programme – independence from study conduct, study-based inspections, facility-based inspections, process-based inspections, QA statement in final report
- Facilities – general requirements, test system facilities, facilities for handling test and reference items, archive facilities, waste disposal
- Apparatus, Material and Reagents – design, calibration, maintenance, labelling, expiry date management
- Test Systems – physical/chemical systems, biological systems (animals, plants)
- Test and Reference Items – receipt, handling, sampling, storage, characterisation
- Standard Operating Procedures – availability, approval, deviations, historical file
- Performance of the Study – study plan, amendments, deviations, conduct, raw data recording
- Reporting of Study Results – final report content, QA statement, Study Director signature
- Storage and Retention of Records and Materials – archives, retention periods, indexing
- Multi-Site Study Management – Principal Investigator role, communication, master schedule
- Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, working papers, non-conformity classification, report writing, management notification, CAPA tracking, effectiveness verification, and audit closure
Target Audience:
- Quality Assurance Personnel
- Internal Auditors (both existing and prospective)
- Study Directors
- Principal Investigators
- Test Facility Management
- Archivists
- Laboratory Supervisors
- Sponsor Representatives
- Test Site Management
Prerequisites: Completion of basic GLP awareness training of at least four hours or equivalent on-the-job experience; at least six months of experience in a nonclinical laboratory testing facility; basic computer skills using Excel and Word.
Pricing: $599.00 with group discounts available.
FAQ:
- What is the difference between the OECD-focused and FDA-focused GLP auditor certifications? The OECD-focused certification covers the international OECD Principles of GLP, while the FDA-focused certification covers 21 CFR Part 58.
- What are the prerequisites for the GLP Internal Auditor Certification? Completion of basic GLP awareness training and at least six months of experience in a nonclinical laboratory testing facility.
- What is the role of the Principal Investigator in multi-site studies? The Principal Investigator is responsible for delegated phases of multi-site studies and must understand their compliance obligations.
- What is the Mutual Acceptance of Data (MAD) agreement? The MAD agreement allows test data generated in one OECD member country to be accepted by other member countries.
- Can I conduct regulatory inspections with this certification? No, the program is designed for internal auditing only and does not qualify individuals for inspections by the national GLP compliance monitoring authority.
Enroll Now: https://www.gxptrainings.com/courses/glp-certified-internal-auditor/
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