Course offering number:0809-501
Course ID:
545
Good Laboratory Practices (GLP)
29 September-1 October 2008
Amsterdam, The Netherlands
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 including
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 the practical implementation of
GLP and discussion including problems that the participants
bring to the course.