Module 01:

• Overview
• Introduction
• Pages
  • Page 01
  • Page 02
  • Page 03
  • Page 04
  • Page 05
  • Page 06
• Assessment
• Questions
  • Question 01
  • Question 02
  • Question 03
  • Question 04
  • Question 05
  • Question 06
• Key Points / Summary
• Further Reading / Resources

Course Introduction

Further Reading and Resources

OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring

• No. 1 – OECD Principles on Good Laboratory Practice

Consensus Documents

• No. 6 – The Application of the GLP Principles to Field Studies
• No. 7 – The Application of the GLP Principles to Short Term Studies
• No. 8 – The Role and Responsibilities of the Study Director in GLP Studies
• No 13. – The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies

Advisory Documents of the Working Group on Good Laboratory Practice

• No.11 – The Roles and Responsibilities of the Sponsor in GLP Studies

Other

• UK Medicines and Healthcare products Regulatory Agency (MHRA)
• The Unites States Food and Drug Administration (FDA)