Course Introduction
This course is an extension to the course 'An Introduction to Good Laboratory Practice' and is made up of five learning modules. This course relates to the Good Laboratory Practice quality system as published by the OECD.
Course Key Points
The course includes:
- An understanding of the wider application of the Good Laboratory Practice quality system including contract work and specific study types - short-term and multi-site study
- Consideration of some additional needs of a multi-site study in respect of organisation and planning, and the management of documentation and records.
- The roles, responsibilities and interactions of the key personnel in multi-site studies
- An appreciation of the interactions of multiple quality assurance groups
- The internationally recognised set of principles relating to the use of computer systems in the OECD GLP Consensus Document No.10
Course Author
Judith Elliott, Research Quality Consultant. Judith was a science teacher before moving to the pharmaceutical industry over 25 years ago. She 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.
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