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The Center for Professional Advancement, Burlingame, CA
June 23-25, 2008
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 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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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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David Long; Consultant
David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years where he gained considerable experience in all three Good Practice disciplines, GLP, GCP and GMP. When he left Rhône- Poulenc he was Senior Director R&D worldwide for Quality and for Process Improvement. Mr. Long has since worked for CHIMEX, a manufacturing subsidiary of the L'Oreal group and also runs his own consultancy company.
Mr. Long has always shown a keen interest in promoting professional QA activities. He was a founder member and President of the French QA Society and a founder member and President of the European QA Federation. He was also the founder and Chief Editor of the Quality Assurance Journal, an international scientific journal specifically addressing subjects of interest to the R&D QA personnel.
He has lectured and trained widely and been an active participant in developing training in Good Practices and QA working with a number of international groups including the OECD and the WHO. His latest contribution through the WHO has been in the co-authoring of a set of guidelines for research performed upstream of the regulatory scene, called "Quality Practices in Basic Biomedical Research".
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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