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.
General
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