Length: 2 Days
Print Friendly, PDF & Email

Fundamentals of Good Laboratory Practices (GLP) Training by Tonex

DFMEA Training | Design FMEA Training

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

 

Request More Information

Please enter contact information followed by your questions, comments and/or request(s):
  • Please complete the following form and a Tonex Training Specialist will contact you as soon as is possible.

    * Indicates required fields

  • This field is for validation purposes and should be left unchanged.

Request More Information

  • Please complete the following form and a Tonex Training Specialist will contact you as soon as is possible.

    * Indicates required fields

  • This field is for validation purposes and should be left unchanged.