Fundamentals of Good Laboratory Practices (GLP) Training by Tonex
This course covers the principles and practices of Good Laboratory Practices (GLP) to ensure the quality and integrity of non-clinical laboratory studies. It focuses on the regulatory requirements, standard operating procedures (SOPs), and quality systems essential for GLP compliance.
Learning Objectives:
- Understand the principles of Good Laboratory Practices (GLP).
- Analyze the regulatory framework for GLP.
- Evaluate the roles and responsibilities in a GLP-compliant laboratory.
- Assess the importance of SOPs in GLP compliance.
- Explore quality assurance and control measures in GLP.
- Develop strategies for implementing and maintaining GLP standards.
Audience:
- Laboratory managers
- Quality assurance professionals
- Regulatory affairs specialists
- Research scientists
- Laboratory technicians
Program Modules:
Module 1: Introduction to Good Laboratory Practices (GLP)
- Overview of GLP principles
- Historical development of GLP
- Key regulatory requirements (FDA, OECD)
- Role of GLP in non-clinical studies
- Case studies of GLP applications
- Future trends in GLP
Module 2: Regulatory Framework for GLP
- Overview of GLP regulations
- Key regulatory bodies (FDA, OECD, EPA)
- Compliance requirements and guidelines
- Regulatory inspections and audits
- Case studies of regulatory compliance
- Future trends in GLP regulation
Module 3: Roles and Responsibilities in a GLP Laboratory
- Responsibilities of study directors
- Role of quality assurance units
- Duties of principal investigators
- Responsibilities of technical staff
- Case studies of GLP roles
- Collaboration and communication in GLP studies
Module 4: Standard Operating Procedures (SOPs)
- Importance of SOPs in GLP
- Developing and maintaining SOPs
- SOPs for key laboratory processes
- Training and adherence to SOPs
- Case studies of SOP implementation
- Best practices for SOP management
Module 5: Quality Assurance and Control in GLP
- Overview of quality assurance (QA) in GLP
- QA audits and inspections
- Quality control (QC) measures
- Data integrity and validation
- Case studies of QA/QC practices
- Strategies for continuous improvement
Module 6: Implementing and Maintaining GLP Standards
- Developing GLP compliance programs
- Training and education for laboratory staff
- Monitoring and auditing laboratory practices
- Risk management and corrective actions
- Case studies of GLP implementation
- Strategies for maintaining GLP compliance