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This indispensable guide offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries - addressing all significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. Elucidating up-to-the-minute industry changes and international concerns, Validation Compliance Annual 1995 examines Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), and Good Automated laboratory Practices (GALPs)... provides unabridged texts of U.S. and European Union regulatory requirements as well as summaries of the validation requirements of other nations... furnishes complete guidelines and tools for system validation... supplies an in-depth look at problems related to inadequate system validation, including actual regulatory citations for noncompliance... explains the rationale behind regulatory compliance policies and inspectional practices... assesses the future of regulatory and industry trends... and more. Containing key bibliographic citations and a thorough glossary of validation terms, Validation Compliance Annual 1995 is an incomparable day-to-day workbook for analytical, pharmaceutical, food, and environmental chemists; instrumentation specialists; industrial, bio-process, chemical, and pharmaceutical engineers; quality and reliability managers and directors; laboratory managers and technicians; computer scientists; and upper-level undergraduate and graduate students in these disciplines.
During the last ten years a considerable volume of inform ation has been accumulated regarding the inelastic behaviour of materials. The increasing number of communications published in specialised journals and also the frequency of meetings in these fields, indicates a considerable research effort aimed at such topics as plasticity, creep, fatigue, visco-plasticity and the like. This fact encouraged a group of Brazilian researchers, stimulated enthusiastically by Professor P. Germain, to submit a proposal for a Symposium on the "Inelastic Behaviour of Plates and Shells" to the General Assembly of IUTAM. Brazil had recently joined IUTAM and the Brazilian Association of Mechanical Sciences was eager to host an IUTAM meeting. In the selection of the subject, it was taken into account, besides a promising number of original contributions, the interest to be raised amongst the Brazilian researchers and engineers, in order to maximise the participation of the host country. The recent steps taken in this country towards the develop ment of the aero-space industry, the construction of nuclear power plants a.nd the off-shore exploration of petroleum have required an intensification of research activities in several fields, structural behaviour of plates and shells being one of the most important. Therefore, the suggested theme would attract the interest or a significant group of Brazilian researchers and engineers and match the necessity for exchanging experience among leading scientists working in those fields."
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