OECD Principles of Good Laboratory Practice (GLP)
This course covers the OECD Principles of GLP as they apply to organisations that conduct non-clinical environmental, health and safety studies. These studies will be submitted to a regulatory authority to register chemicals such as pharmaceuticals, agricultural, veterinary products and industrial chemicals.
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Course overview
OECD Principles of Good Laboratory Practice (GLP) is a quality system that covers the organisational process and conditions under which non-clinical health and environmental safety studies are planned, recorded, monitored and reported.
“In my experience, NATA courses are good. Lots of information, interactive and generally engaging.”
Kate Porter
What you will learn
This course explains the OECD principles of GLP as they are applied to companies that need to collect and submit data for the registration of chemicals such as pharmaceuticals, agricultural and veterinary products and industrial chemicals.
This includes:
- GLP and the hierarchy of OECD documents
- Different types of organisations and key staff
- Quality assurance processes e.g., auditing
- Standard Operating Procedures (SOP)
- The GLP recognition process
In addition:
- Understanding document operations and activities in accordance with OECD GLP principles
- The roles and responsibility of staff
- Planning and conducting a study to meet requirements
- Compiling a GLP study report
- Compliance and Quality Management
- Requirements for multi-sites
- Plan and validate computer systems
Who should do the course?
This course is ideal for individuals who:
- have an interest in, or who are involved in, GLP studies
- are from organisations that conduct non-environmental health and safety studies
- hold or are entering GLP study roles such as:
- Study Director
- Principle Investigator
- Quality Assurance
- Archivist
This course also has value for sponsors who are submitting data to regulators in Australia and overseas.
