Good Laboratory Practices Certification Compliance Course

Introduction

GLP course covers Uncertainty Measurement, Data & Method Validation, and SPC, aligned with ISO/IEC 17025.  ​It equips participants with the knowledge to implement effective quality management systems and meet global regulatory expectations in analytical laboratories. ​Our course explores the full spectrum of GLP elements, including laboratory organization, personnel qualifications, and equipment maintenance. A core component focuses on measurement uncertainty, teaching attendees how to identify sources, quantify them accurately, and calculate combined and expanded uncertainty in analytical procedures. You can also gain hands-on insight into statistical process control (SPC) for laboratory performance monitoring and continuous quality improvement. Through a mix of theory and practical applications, this course ensures you will be proficient in method validation techniques and fully prepared to align your laboratory practices with ISO 17025 requirements. This leads to enhanced regulatory compliance and improved decision-making based on validated and traceable data, crucial for reliable laboratory operations.

Objectives

By the end of this GLP: Uncertainty Measurement, Data Validation, Method Validation & Statistical Process Control (SPC) in Analytical Laboratory according to ISO 17025 course, participants will be able to:​

• Understand the framework of quality assurance in laboratories and the significance of implementing the ISO/IEC 17025 standard.
• Define Good Laboratory Practice (GLP) and explain its relevance to modern laboratories and technology transfer.
• Evaluate the financial and operational impact of non-compliance with GLP.
• Identify and interpret GLP standards and international regulations (OECD, USA, Canada, Europe, Japan) that govern laboratory operations.
• Differentiate between various regulatory systems, particularly the USA and OECD GLP frameworks, and determine their applicability to their own laboratories.
• Recognize and address critical compliance issues across GLP components, including organization, personnel, facilities, equipment, testing procedures, controls, documentation, and reporting.
• Understand the concepts of measurement uncertainty, including sources, estimation processes, and how to conduct uncertainty analysis.
• Apply techniques for calculating combined and expanded uncertainty, and follow best practices for reporting measurement uncertainty.
• Implement statistical process control (SPC) to monitor and enhance laboratory process stability and capability.
• Conduct method validation in accordance with ISO/IEC 17025 requirements and apply appropriate data validation techniques.

Training Methodology

We employ a comprehensive and applied learning strategy, integrating theory with real-world implementation:

• 30% Conceptual Learning: Expert-led sessions on catalytic theory and engineering principles
• 20% Interactive Workshops: Group exercises, presentations, and technical discussion forums
• 30% Case-Based Learning: Industry-specific examples and troubleshooting scenarios
• 20% Technology Integration: Digital tools, simulations, and catalyst modeling applications

Who Should Attend?

Our Good Laboratory Practice training course is highly beneficial for a wide range of laboratory professionals, including:

• Laboratory Managers, Superintendents, and Supervisors
• Scientists, Physicians, and Laboratory Analysts
• Chemists and Senior Chemists
• Laboratory Technicians and Senior Technicians
• Quality Assurance and Quality Control Professionals
• R&D Personnel and Statutory Government Employees
• Officers, Coordinators, and Certification Auditors
• Personnel from Third-Party Inspection and Certification Bodies

Course Outline

Module 1: GLP Fundamentals and Quality Assurance

• Pre-test assessment of existing knowledge
• Principles of Quality Assurance and Quality Control
• Importance of ISO/IEC 17025 in Laboratory Operations
• Role of GLP in Modern Laboratories and Technology Transfer

Module 2: GLP Standards, Compliance, and Non-Compliance Risks

• Economic and Operational Impact of GLP Non-Compliance
• Overview of International GLP Standards and Guidelines
• Key Requirements for GLP Compliance

Module 3: GLP Organizational and Operational Requirements

• Common Compliance Issues in GLP
• Organizational Structure and Human Resources in GLP
• Facilities, Equipment, and Operational Protocols
• Testing Methods, Controls, and Protocol Development
• Records Management and Reporting Standards
• GLP Scope, Applications, and Uncertainty Components
• Conducting Analytical Measurements and Performance Studies

Module 4: Measurement Uncertainty in Analytical Laboratories

• Introduction to Measurement Uncertainty Estimation
• Identifying and Categorizing Uncertainty Sources
• Techniques for Quantifying Uncertainty in Measurements

Module 5: Uncertainty Calculation, Reporting, and SPC

• Calculating Combined and Expanded Measurement Uncertainty
• Procedures for Documenting and Reporting Uncertainty Results
• Introduction to Statistical Process Control (SPC)
• Application of SPC Tools for Laboratory Performance Monitoring

Module 6: Capstone and Assessment

• Review of Core Topics and Key Learnings
• Final Group Discussion and Q&A
• Post-Test Evaluation
• Certificate Presentation