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.<br><br>
The lectures will be supplemented by a question and answer
session conducted by the Faculty and by workshops involving
problem-solving exercises.<br><br>
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.<br><br>
Emphasis will be placed on this practical implementation of GLP
and discussion including consideration of problems that the
participants bring to the course.