Overview
Good Laboratory Practice (GLP) training is not a one-time event; it requires ongoing education to keep personnel current with regulatory requirements and industry best practices. The FDA’s GLP regulations under 21 CFR Part 58 establish the requirement for training, but the frequency of retraining is not explicitly specified in the regulations. However, regulatory authorities expect that personnel maintain their competence through continuing education and periodic refresher training. This guide explains who needs GLP training and how often it must be refreshed.
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Who Needs GLP Training?
GLP training is required for all personnel involved in nonclinical laboratory studies that support regulatory submissions. The scope of training depends on the role and responsibilities of the individual. The FDA expects that personnel have the proper education, training, and experience to perform their assigned functions.
Test Facility Management – Management is responsible for ensuring that personnel are adequately trained. Under 21 CFR 58.31, testing facility management must ensure that personnel have appropriate training.
Study Directors – Study directors are responsible for the overall conduct of the study. They must have comprehensive GLP training to fulfill their responsibilities.
Quality Assurance Personnel – QA personnel must be trained in GLP requirements to effectively monitor studies and conduct inspections.
Study Staff – All personnel performing tasks in the study must be trained in GLP requirements. This includes laboratory technicians, analysts, and other support staff.
How Often Must GLP Training Be Refreshed?
While the FDA’s GLP regulations do not specify an exact frequency for retraining, regulatory authorities expect that personnel maintain their competence through periodic refresher training. The appropriate amount, frequency, and methods of training are case-specific and depend on several factors.
Regulatory Expectations – Regulatory authorities, including the FDA and OECD, expect that personnel maintain their competence through continuing education. In practice, many organizations default to an annual or biennial GLP refresher training cycle.
Risk-Based Frequency – The frequency of retraining should be based on the risk associated with the tasks performed. Personnel performing critical tasks may require more frequent retraining.
Regulatory Changes – When significant regulatory updates occur, such as revisions to the OECD GLP principles or 21 CFR Part 58, retraining is expected.
New Technologies – The introduction of new technologies, such as computerized systems in GLP environments, may require additional training.
Factors That Trigger Retraining
Several factors may trigger the need for GLP retraining. Organizations should consider these factors when establishing their training programs.
Significant Regulatory Changes – When regulatory requirements change, personnel must be retrained to understand the new requirements.
New Technologies – The introduction of new equipment or computerized systems may require training.
New Personnel – New employees require initial GLP training before being assigned to study tasks.
Performance Issues – If personnel demonstrate performance issues or make errors, retraining may be necessary.
Internal Audits – Internal audit findings may identify training gaps that require retraining.
Best Practices for GLP Training Frequency
The appropriate amount, frequency, and methods of training are case-specific and depend on the role and tasks of the individual. However, industry best practices can provide guidance.
Initial Training – Comprehensive initial training should be provided before personnel are assigned to study tasks. This training should cover all relevant GLP requirements.
Annual Refresher – Many organizations require annual GLP refresher training to maintain competence and stay current with regulatory updates.
Biennial Refresher – Some organizations follow a biennial (every two years) refresher cycle.
Event-Triggered Training – Training should also be provided when significant changes occur, such as regulatory updates or new technologies.
Documentation of Retraining
GLP retraining must be documented and records must be maintained. Documentation is essential for regulatory inspections and demonstrates that the organization has met its training obligations.
Training Records – Records should include the training title, date of completion, the name of the trainer or training provider, and the content covered.
Competency Assessment – Documentation should demonstrate that the training was effective and that personnel are competent to perform their duties.
Retraining Records – When retraining is provided, it must be documented and records must be maintained.
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.
Scope: The program begins with the historical context that led to the establishment of GLP regulations and systematically builds knowledge across the entire lifecycle of a nonclinical laboratory study.
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
- Quality Assurance Programme – monitoring, inspections, and compliance verification
- Facilities and Environmental Conditions – requirements for GLP-compliant facilities
- Equipment Management – qualification, calibration, and maintenance
- 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:
- Who needs GLP training? All personnel involved in nonclinical laboratory studies that support regulatory submissions, including test facility management, study directors, quality assurance personnel, and study staff.
- How often must GLP training be refreshed? While not explicitly specified in the regulations, regulatory authorities expect that personnel maintain their competence through periodic refresher training, typically annual or biennial.
- What triggers the need for GLP retraining? Significant regulatory changes, new technologies, new personnel, performance issues, and internal audit findings may trigger retraining.
- How should GLP training be documented? Training records should include the training title, date of completion, the name of the trainer, and the content covered.
- What is the role of the study director in GLP? The study director is responsible for the overall conduct of the study and must be properly trained in GLP requirements.
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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.
Scope: The curriculum addresses the complete range of GLP requirements, including organizational responsibilities, quality assurance, study conduct, data integrity, and archival management.
Description of Modules: The curriculum covers 12 comprehensive sections:
- Test Facility Organisation and Personnel – responsibilities of management, Study Director, Principal Investigator
- Quality Assurance Programme – independence, inspections, QA statement
- Facilities – general requirements, test system facilities, archive facilities
- Apparatus, Material and Reagents – design, calibration, maintenance, labelling
- Test Systems – physical/chemical and biological systems
- Test and Reference Items – receipt, handling, sampling, storage, characterisation
- Standard Operating Procedures – availability, approval, deviations
- Performance of the Study – study plan, amendments, deviations, conduct
- Reporting of Study Results – final report content, QA statement
- Storage and Retention of Records and Materials – archives, retention periods
- Multi-Site Study Management – Principal Investigator role, communication
- 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:
- Who needs OECD GLP training? Personnel involved in nonclinical studies that may be submitted to international regulatory authorities.
- How often should OECD GLP training be refreshed? Regulatory authorities expect periodic refresher training, typically annual or biennial.
- 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.
- What is the role of the Principal Investigator in multi-site studies? The Principal Investigator is responsible for delegated phases of multi-site studies.
- What triggers retraining for OECD GLP? Significant regulatory changes, new technologies, new personnel, and performance issues may trigger retraining.
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.
Scope: The program integrates GLP requirements for nonclinical laboratory studies with internal auditing practices based on ISO 19011. The program is designed for internal auditing only.
Description of Modules: The curriculum covers operational areas including:
- Facilities – animal care areas, test article handling areas, laboratory operation areas
- Equipment – design, maintenance, calibration, and inspection requirements
- Testing facility operations – standard operating procedures, reagents, animal care
- Test and control articles – characterization, handling, and mixtures
- Protocol and conduct of studies – protocol approval, changes, and study conduct
- Records and reports – final reporting, storage and retrieval, retention
- Quality assurance unit – responsibilities, inspections, reporting, independence
- Personnel and management – training, job descriptions, study director responsibilities
- Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, non-conformity classification, report writing, CAPA tracking
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; at least six months of experience; basic computer skills.
Pricing: $599.00 with group discounts available.
FAQ:
- Who needs GLP auditor certification? Quality assurance personnel, internal auditors, and professionals responsible for monitoring GLP compliance.
- What are the prerequisites for the GLP Internal Auditor Certification? Completion of basic GLP awareness training and at least six months of experience.
- How often should GLP auditor certification be renewed? It is recommended to maintain certification through continuing education and periodic refresher training.
- What is ISO 19011 and why is it important for auditors? ISO 19011 provides guidelines for auditing management systems.
- Can I conduct regulatory inspections with this certification? No, the program is designed for internal auditing only.
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).
Scope: The program integrates GLP requirements for single-site and multi-site studies with internal auditing practices based on ISO 19011. The program is designed for internal auditing only.
Description of Modules: The curriculum covers:
- Test Facility Organisation and Personnel – responsibilities of management, Study Director, Principal Investigator
- Quality Assurance Programme – independence, inspections, QA statement
- Facilities – general requirements, test system facilities, archive facilities
- Apparatus, Material and Reagents – design, calibration, maintenance, labelling
- Test Systems – physical/chemical systems, biological systems
- Test and Reference Items – receipt, handling, sampling, storage, characterisation
- Standard Operating Procedures – availability, approval, deviations
- Performance of the Study – study plan, amendments, deviations, conduct
- Reporting of Study Results – final report content, QA statement
- Storage and Retention of Records and Materials – archives, retention periods
- Multi-Site Study Management – Principal Investigator role, communication
- Auditing practices – audit programme management, audit planning, checklist design, evidence collection, sampling, non-conformity classification, report writing, CAPA tracking
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; at least six months of experience; basic computer skills.
Pricing: $599.00 with group discounts available.
FAQ:
- Who needs OECD GLP auditor certification? QA personnel and internal auditors working in facilities that conduct studies according to OECD GLP principles.
- How often should OECD GLP auditor certification be refreshed? It is recommended to maintain certification through continuing education and periodic refresher training.
- What are the prerequisites for the OECD GLP Internal Auditor Certification? Completion of basic GLP awareness training and at least six months of experience.
- What is the role of the Principal Investigator in multi-site studies? The Principal Investigator is responsible for delegated phases of multi-site studies.
- Can I conduct regulatory inspections with this certification? No, the program is designed for internal auditing only.
Enroll Now: https://www.gxptrainings.com/courses/glp-certified-internal-auditor/
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