CfPA - The Center for Professional Advancement, Boca Raton, FL
February 24-26, 2010
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 responsibilities
• 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 and FDA Good Laboratory Practices and their application. 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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