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CfPA - The Center for Professional Advancement, New Brunswick, NJ
October 27-28, 2011
Who Should Attend
This advanced course is designed for Quality Assurance personnel, or managers wishing to know more about how best to implement and audit GLP in their facilities. As the course explores issues innovative to the GLP arena, it provides an opportunity for experienced personnel to update their competencies. Participants may come from:
• Industry
• Academia
• Government
• Contract Testing Facilities
Description
This course will explore the activities of a Quality Assurance department when auditing studies for GLP compliance. All aspects of QA work will be discussed including; the preparation of planning documents, review of protocols and SOPs, inspection of facilities and processes, performance of inspections of in-life phases and the audit of final reports. The Director will consider how an effective rationale can be developed to provide a solid basis for the implementation of a QA audit & inspection program. Consideration will be given to the auditing of suppliers and subcontractors and the role of QA vis-à-vis computer systems. The reference materials will be the FDA and OECD Good Laboratory Practice Regulations and the series of monographs of the OECD relating to the interpretation of the GLP text. Time will also be given to the setting up of quantitative techniques for the measurement of Quality, enabling participants to follow the compliance level within laboratories. Lectures will be supplemented with many interactive case studies, problem solving experiences and workshops. Emphasis will be on the options available for meeting regulatory requirements.
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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 & Associates International Consultancy 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 also runs his own consultancy company.
Mr. 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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sberg@cfpa.com
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