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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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February 24, 2020 |
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CfPA- The Center for Professional Advancement, Paris, France
8-10 June, 2020
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
Maximize Your Learning!
Attend this course and its Companion Courses:
GLP and Quality Assurance: Developing a GLP Compliant QA Program
11-12 June 2020 • Paris • Course ID #2564
GLP Study Director
15-16 June 2020 • Paris • Course ID #2136 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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knee@cfpa.com
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Liability, Copyright and Imprint. |
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“Tell me and I forget, teach me and I may remember, involve me and I learn”
This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem solving and thus learn about Good Laboratory Practice (GLP) Regulations.
Overall, the main intent is to review all the requirements of Good Laboratory Practices (GLP) regulations for facilities engaged in regulated Safety Testing. The learning initiative is achieved through a mixture of short lectures, illustrative answers to FAQs and by collective problem solving workshops. The aim is to ensure that each participant is personally faced with real life situations for which GLP compliant solutions have to be found.
The notions of procedures, processes and systems will be addressed via workshops on process mapping, and the implementation of procedures within the context of the GLP laboratory. The participants will also be challenged with the issues of data integrity and the problems of study reconstruction. Participants will be asked to give their own reactions to real-life situations and to solve the issues arising in a way compliant with the regulations.
Involving the participants in GLP decision making processes means that they will learn and understand rather than just receiving information as they would from a standard course. The course will concentrate on existing OECD and FDA Good Laboratory Practices and their application to the workplace including recent developments such as multi-site and short term studies. Lectures will address how to prepare and react to authoritative inspections.
Although there will be ample time for participants to ask questions, the course directors will also hold an optional, free, two-hour “GLP-Clinic” after the end of the course for those who have detailed or specific problems that they would like to discuss with them, either privately (if your institute considers the issue to be confidential) or openly with all participants if the topic does not require confidential treatment.