Introduction to Good Laboratory Practice (GLP)

5/5
116
intro to GLP

Duration :

10

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

The goal of non-clinical health and environmental safety studies is the generation of accurate data that can be put to use in making inferences as intended. It is expected that given the same materials and conditions, consistent results should be produced from such studies. GLP is a set of guidelines that protects the integrity and reliability of the results obtained from any of such laboratory studies. This is done by standardizing the preparation, methods, recording, processing, and archiving of data about these studies. This course introduces you to the concept of GLP starting at the history of the concept which points out why it was needed in the first place. You also get to see what role the OECD played in bringing it into existence and making it a global concept. Finally, you will learn how it applies to the stages of clinical trials whilst getting familiar with the fundamental points of GLP (Resources, Rules, Characterization, and Quality Assurance).

 

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

 

Curriculum

 

Introduction

 

Lesson 1: The History of GLP

 

  • GLP Regulations in 1979 and 1980
  • First OECD Principles of GLP
  • Globalization of GLP

 

Lesson 2: The Drug Development Process and The Role of GLP

 

  • Phase 1
  • Phase 2
  • Phase 3
  • Phase 4

 

Lesson 3: “Resources” as a Fundamental Point of GLP

 

  • Organization and Personnel
  • Facilities and Equipment

 

Lesson 4: “Rules” as a Fundamental Point of GLP

 

  • Protocols
  • Written Procedures
  • The Study Director

 

Lesson 5: “Characterization” as a Fundamental Point of GLP

 

  • The Test Item
  • Test System

 

Lesson 6: “Quality Assurance” as a Fundamental Point of GLP

 

  • Protocol (or Study Plan) Review
  • SOP Review
  • Planning
  • Adults and Inspections

 

Glossary

 

Conclusion

 

Quiz

 

Author:

eliot
Eliot Zate
Eliot Zate has worked in the pharmaceutical industry for more then 25 years ago. He is a recognised expert in the application of Good Laboratory Practice, and has carried out assessments of compliance with the Principles for many organisations worldwide.

Reviews:

5/5
116
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