The Center for Professional Advancement, Amsterdam
26-28 November 2007
Who Should Attend:
This course is intended for all management within industry, government, academia and/or contract biological testing facilities especially:Scientists
Regulatory/Compliance Personnel
Quality Assurance Staff
Those newly assigned GLP resonsibilities
More experienced personnel needing to update their knowledge
Description:
The main intent of this course is to review the requirements imposed by Good Laboratory Practices (GLP) regulations for facilities engaged in, toxicology and product safety testing, primarily in animals and biological test systems. The responsibilities and functions of management, the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various procedures for meeting the requirements of the regulations will be presented. The lectures will be supplemented by a question and answer session conducted by the Faculty and by workshops involving problem-solving exercises. The course will concentrate on OECD Good Laboratory Practices guidelines and their application in member countries, particularly Europe. This will include recent developments regarding multi-site studies and their practical interpretation. Additionally there will be sessions relating to computer validation, particularly as required by FDA in their 21 CFR Part 11 documents. Emphasis will be placed on this practical implementation of GLP and discussion including consideration of problems that the participants bring to the course.
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