Good Laboratory Practice
For whom: Employees and staff firstly orientating themselves on GLP and quality management systems and laboratory accreditation
Good Laboratory Practice, GLP, applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment. It refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physico-chemical properties through acute to chronic toxicity tests.
GLP codes of conduct have been developed by the OECD, the FDA and the European Union. In this training course we will visit the various requirements, and the degree of equivalence and/or difference with, e.g. the requirements from the ISO/IEC 17025:2005 and :2017 will be discussed. Specific attention will be given to the requirements on
- The study plan
- Responsibilities of the principal investigator
- The quality assurance programme
- The test systems
- Reporting
- Documentation and archiving
Group size: Max. 25
Duration: 3 days