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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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July 07, 2017 |
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CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 23-25, 2017
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
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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 David Long; Long and Associates International Consulting Ltd. |
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 now runs his own consultancy company.
David Long has always shown a keen interest in promoting professional QA activities. He was a founding member and President of the French QA Society and a founding 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 R&D and QA personnel.
He has lectured and trained widely and has 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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jmorbit@cfpa.com
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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.
Maximize Your Learning!
Attend this course and its Companion Course:
GLP and Quality Assurance: Developing a GLP Compliant QA Program
October 26-27, 2017 • New Jersey • Course ID #2564