Overview
Before a nonclinical study can be conducted in compliance with Good Laboratory Practice (GLP) regulations, all personnel involved must have appropriate training. The FDA’s GLP regulations under 21 CFR Part 58 establish specific expectations for the training and qualification of personnel. The regulations require that personnel assigned to nonclinical GLP activities have the proper education and training to protect scientific study data integrity and quality. This guide explains who needs GLP training before a nonclinical study and what the FDA expects.
https://www.gxptrainings.com/course-category/glp-training
The FDA’s GLP Training Requirements
The FDA’s GLP regulations under 21 CFR Part 58 set forth clear requirements for personnel training and qualification. Subpart B (Organization and Personnel) of 21 CFR 58 describes the key elements and expectations relating to personnel assigned to nonclinical GLP activities.
Personnel Qualifications – Personnel must have the proper education, training, and experience to perform their assigned functions. The training period and requirements vary depending on the role.
Management Responsibility – It is facility management’s responsibility to assign appropriately trained persons to a study and to ensure that the person assigned is trained and capable of completing the tasks relevant to their assignment.
Documentation – Training must be documented and records must be maintained. This is essential for regulatory inspections.
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.
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.
What the FDA Expects from Training Programs
The FDA expects that GLP training programs cover the essential components of GLP regulations and are tailored to the specific roles of personnel. The training should provide practical guidance on implementing and maintaining GLP compliance.
Comprehensive Content – Training should cover the full scope of GLP requirements, including organization and personnel, facilities, equipment, study conduct, and documentation.
Role-Specific Training – Training should be tailored to the specific responsibilities of each role. The training requirements are different for a study pathologist than for a technician working on primate studies.
Practical Application – Training should emphasize practical application of GLP principles in the laboratory setting. This includes deviation management, out-of-specification (OOS) results, analytical errors, and compliance failures.
Record Keeping – Training records must be maintained and be readily accessible for inspections.
Consequences of Inadequate GLP Training
Failure to provide adequate GLP training can have serious consequences for organizations and individuals. The FDA expects documented evidence of training during inspections.
Regulatory Actions – Inadequate training can lead to FDA warning letters, fines, or rejection of study data.
Data Integrity Issues – Untrained personnel may produce unreliable data that could compromise regulatory submissions.
Inspection Findings – Incomplete or inadequate training records are a common finding during FDA inspections.
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 before a nonclinical study? All personnel involved in nonclinical laboratory studies that support regulatory submissions, including test facility management, study directors, quality assurance personnel, and study staff.
- What does the FDA require for GLP training? The FDA requires that personnel have the proper education, training, and experience to perform their assigned functions, as described in 21 CFR Part 58 Subpart B.
- 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.
- What is the role of the Quality Assurance Unit in GLP? The QA unit is responsible for monitoring studies, conducting inspections, and ensuring compliance with GLP regulations.
- How should GLP training be documented? Training must be documented and records must be maintained for regulatory inspections.
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.
Scope: The curriculum addresses the complete range of GLP requirements, including 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.
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
- 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, including study directors, QA personnel, and laboratory staff.
- 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 are the OECD GLP principles? The OECD GLP principles are international standards for quality and validity of nonclinical safety data.
- How do OECD GLP principles relate to FDA regulations? The OECD GLP principles are consistent with and inform FDA’s 21 CFR Part 58.
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 in nonclinical laboratories.
- 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.
- 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.
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.
- 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.
- 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.
Enroll Now: https://www.gxptrainings.com/courses/glp-certified-internal-auditor/
Get Your Team Offer
For organizations looking to enroll multiple participants, we offer specialized team packages and volume discounts. Please reach out to our partnership team to discuss your specific needs and scores.
Contact Us: https://www.gxptrainings.com/contact-us/
Author
