Good Laboratory Practice
A professionally developed, interactive and engaging online training course.
Delivering unique, exciting and interactive e-learning technology courses.
ABOUT THE COURSE
Good Laboratory Practice (GLP) regulations were developed in the late 1970’s in response to malpractice in research and development activities by pharmaceutical companies and the Clinical Research Organisations (CROs). GLP regulates the practices of scientists working on the safety testing of prospective drugs. Compliance with GLP ensures the quality and integrity of data and that a true representation of that data is presented to the regulatory authorities.
This interactive and engaging course examines the reasons why GLP is needed. It examines the regulations themselves, considers the personnel, equipment and facilities needed to conduct a non-clinical laboratory study that is GLP compliant, and uses scenarios to look at how these regulations apply in our own workplaces.
Finally, an online learning platform that’s fun, engaging and can be taken on any device, anywhere, anytime.
WlLL THE COURSE TAKE?
his course takes approx. 2-3 hrs to complete. This time will vary depending on the user’s previous knowledge, and as the course contains lots of links to more information, it will also depend how many the user chooses to access.
At the end of the course the user can download and print their own certificate as a record of their course completion.
Introduction to GLP
- Why is GLP needed?
- What is the history of GLP?
- What is GLP?
Chapter 1 - General Provisions
Chapter 2 - Organisation & Personnel
- Who are personnel in a non-clinical laboratory study?
- Inspection of a testing facility
- Roles and responsibilities
- Quality Assurance Unit
Chapter 3 - Facilities
- Facility requirements
- Animal Facilities
- Animal supply facilities
Chapter 4 - Equipment
- Fitness for purpose
- GLP expectations for maintenance and calibration of equipment
Chapter 5 - Testing Facilities Operations
- Quality Assurance
- Animal care
Chapter 6 - Test & Control Articles
- Storage and handling
- Mixtures of articles with carriers
Chapter 7 - Protocol for and Conduct of a Nonclinical Laboratory Study
- What a protocol is and what it should contain
- Study conduct
Chapter 8 - Records and Reports
- Recording and reporting requirements
- Record retention rules
Chapter 9 - Disqualification of Testing Facilities
- Purpose of disqualification
- Grounds for disqualification
- Processes and procedures
Ewelina Testoni, PhD
Fiona Duthie, PhD
Stefan Smet, Writingale
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