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Course Name GLP: Good Laboratory Practices
Audience Employees of clinical laboratories, Management, compliance and Administration departments. Scientists, Manufacturers etc and any other personnel involved with clinical practices.
Course Requirements Physicians, allied healthcare providers, and others with the interest in management of patients with Osteoarthritis.

Plug-in Requirements
ØMacromedia Flash plug-in for Windows for IE/NN.
Pre-requisites None
Course Duration Approximately One hour. Time may vary based on modem speed, prerequisite knowledge and other factors
Course Objectives This course will introduce you to the concepts and requirements necessary for compliance with Good Laboratory Practices (GLPs). This course will help prepare you to establish and document a system for GLP controls required to test medical products where data is intended for inclusion into a regulatory filling in the United States, the European Union, Japan and many parts of the world.
The course is divided into four sections
  • The first section, PURPOSE AND ELEMENTS OF GLP, provides a basic history and framework for understanding safety testing under the regulations intended to ensure data integrity during nonclinical safety testing
  • The second section, GLP RESPONSIBILITIES, covers expectations of regulators for the responsibilities of management of staff in a nonclinical testing laboratory.
  • The third section, AREAS OF GLP, describes the basic responsibilities of a nonclinical safety testing organized along the lines of the U.S. and EU GLPs
  • The fourth section, DOCUMENTATION, discusses documentation which must be assembled and maintained in a GLP testing or sponsor facility during a GLP study as well as how facilities must maintain data and samples after a test is complete.
Course Outline
  1. Introduction
    2.
    1. Course Information
    2. Interface Tour
    3. Course Overview
      4.
  2. Purpose and elements of GLP
    3.
    1. Objectives
    2. Pre-test
    3. Origin of GLP regulations
    4. Protocols and Reports
    5. Quality Assurance Programs
    6. Inspection of GLP Labs
    7. Progress Check
      8.
  3. GLP Responsibilities
    4.
    1. Objectives
    2. Pre-test
    3. Responsibilities of Management/Personnel
    4. Responsibilities of the Study Director
    5. Responsibilities of Quality Assurance
    6. Progress Check
      7.
  4. Areas of GLP
    5.
    1. Objectives
    2. Pre-test
    3. Facilities and Instrumentation
    4. Reagents and Solutions
    5. Animal Care
    6. Test and Control Materials
    7. Progress Check
      8.
  5. Documentation
    6.
    1. Objectives
    2. Pre-test
    3. Standard Operating Procedures
    4. Document Change Control
    5. Data recording Rules
    6. Records/Archive Management
    7. Progress Check
      8.
  6. Conclusions
    7.
    1. Summary
      2.
  7. Glossary/Resources
    8.
    1. Glossary
    2. Resources
      3.
     
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