GLP

Good Laboratory Practice Training

This course is prepared for companies and individuals that need to get familiar with the principles of GLP. It covers the criteria for the performance of non-clinical health and environmental safety studies upon which hazard assessments are based.

€59 Enroll

Why enroll in this course?

Course Syllabus

  • Principle
  • What is Good Laboratory Practice
  • Purpose
  • Scope
  • Examples of Studies Carried Under GLP
  • GLP Directives
  • OECD
  • History of Good Laboratory Practice
  • Principle
  • Personnel Responsibilities
  • Test Facility Management
  • Master Schedule
  • Study Director
  • Example of Quality Assurance Statement
  • Principal Investigator
  • Quality Assurance Unit
  • Inspections/Audits Performed by QA
  • Quality Assurance Statement
  • Principle
  • Separation
  • Facilities
  • Equipment
  • Equipment Calibration
  • Equipment Maintenance
  • Computerized Systems
  • Computerized Systems and Responsibilities
  • Disaster Recovery
  • General
  • Test Item Definition
  • Test Item Storage and Receipt
  • Test Item Use
  • Test System Definition
  • Test System - General Principles
  • Institutional Animal Care and Use Committee
  • Definition
  • General
  • To be Considered
  • Definition
  • Study Plan Content
    • Identification
    • Title and Statement of Purpose
    • Identification of Test items
    • Information Concerning the Sponsor and the Test Facility
    • Dates
    • Justification for Selection of the Test System and Description of Test System
    • Experimental Design of the Study
  • Protocol amendments – definition and examples
  • Types of Protocol Amendments
  • Protocol Deviation – definition and examples
  • Data Recording
  • Raw Data
  • How to Make a Correction
  • ALCOA Principle
  • Requirements for Electronic Raw Records
  • Final Report
  • Content of the Final Report
  • Storage and Retention of Records and Materials
  • To be Considered

Ready to get started?

€59 Enroll