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Good laboratory practice for nonclinical studies
The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.
Good laboratory practice : The why and the how
The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field studies or ecotoxicology studies. At the same time the term “Good Laboratory Practice” has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work.
Fundamental approaches to software engineering ; Vol. 3442 ; 8th International Conference, FASE 2005, Held as Part of the Joint European conferences on theory and practice of software, ETAPS 2005, Edinburgh, UK, April 4-8, 2005, Proceedings
ETAPS 2005 was the eighth instance of the European Joint Conferences on Theory and Practice of Software. ETAPS is an annual federated conference that was established in 1998 by combining a number of existing and new conf- ences. This year it comprised ?ve conferences (CC, ESOP, FASE, FOSSACS, TACAS), 17 satellite workshops (AVIS, BYTECODE, CEES, CLASE, CMSB, COCV, FAC, FESCA, FINCO, GCW-DSE, GLPL, LDTA, QAPL, SC, SLAP, TGC, UITP), seven invited lectures (not including those that were speci?c to the satellite events), and several tutorials. We received over 550 submissions to the ?ve conferences this year, giving acceptance rates below 30% for each one. The events that comprise ETAPS address various aspects of the system - velopment process, including speci?cation, design, implementation, analysis and improvement. The languages, methodologies and tools which support these - tivities are all well within its scope. Di?erent blends of theory and practice are represented, with an inclination towards theory with a practical motivation on the one hand and soundly based practice on the other. Many of the issues involved in software design apply to systems in general, including hardware s- tems,andtheemphasisonsoftwareisnotintendedtobeexclusive.
Foundations of software science and computational structures ; Vol.3441 : 8th International Conference, FOSSACS 2005, Held as part of the joint European conferences on theory and practice of software, ETAPS 2005
ETAPS 2005 was the eighth instance of the European Joint Conferences on Theory and Practice of Software. ETAPS is an annual federated conference that was est- lished in 1998 by combining a number of existing and new conferences. This year it comprised ?ve conferences (CC, ESOP, FASE, FOSSACS, TACAS), 17 satellite wo- shops (AVIS, BYTECODE, CEES, CLASE, CMSB, COCV, FAC, FESCA, FINCO, GCW-DSE, GLPL, LDTA, QAPL, SC, SLAP, TGC, UITP), seven invited lectures (not including those that were speci?c to the satellite events), and several tutorials. We - ceived over 550 submissions to the ?ve conferences this year, giving acceptance rates below 30% for each one. Congratulations to all the authors who made it to the ?nal program! I hope that most of the other authors still found a way of participating in this exciting event and I hope you will continue submitting. The events that comprise ETAPS address various aspects of the system devel- ment process, including speci?cation, design, implementation, analysis and impro- ment. The languages, methodologies and tools which support these activities are all well within its scope.
