Good Laboratory Practices (GLP)
March 16 - 18, 2009
Boca Raton, FL
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This course is available as a client site course. Please click here for more information.
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.