MTU Cork Library Catalogue

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Good laboratory and clinical practices : techniques for the quality assurance professional / edited by P.A. Carson and N.J. Dent..

Contributor(s): Carson, P. A.. (Phillip Alfred), 1944- | Dent, N. J. (Nigel J.).
Material type: materialTypeLabelBookPublisher: Oxford : Heinemann Newnes, 1990Description: xxiv, 390 p. : ill. ; 24 cm. + hbk.ISBN: 0434902810.Subject(s): Medical laboratories -- Quality control | Biological laboratories -- Quality controlDDC classification: 506.85
Contents:
Part One: Background -- An introduction to good laboratory practice (GLP) / R D Broad and N J Dent -- GLP legislation / K W G Shillam -- Overall responsibilities for GLP / P D Lepore -- Part Two: The quality assurance program -- The master schedule / J E Goeke -- The study plan / P R Cooper -- Standard operating procedures / N Gawadi -- Procedural inspections / R Kaplan -- Process inspections / D S Goldman -- Facilities inspections / A Waddell -- Data audits / J Birnie -- Report audits / D L Colinese -- The QA statement / S Trenchard-Morgan -- Archives / R G Lawrence -- Staff records / S J Harston -- Part three -- Quality assurance unit / J Maple -- QA and contract houses / D J Ford -- Computer auditing / J B Doherty -- Statistics for QA auditors of GLP and GCP studies / I J Townshend -- GLP in the analytical laboratory / M F Turner -- QA and GLP in pathology / G Falconi -- GLP in drug metabolism and pharmacokinetics / N J Dent -- GLP and QA in ecotoxicology/ H R Roderick -- Training and awareness of GLP and GCP / H Neal -- GLP compliance monitoring procedures / M de Barros -- Laboratory accreditation:the role of NAMAS and its collaboration with the UK GLP monitoring unit / B Broderick and J Beaumont -- QA in good clinical research practice / G F Moss -- QA in good manufacturing practice / G F Moss.
Holdings
Item type Current library Call number Copy number Status Date due Barcode Item holds
General Lending MTU Bishopstown Library Lending 506.85 (Browse shelf(Opens below)) 1 Available 00012152
Total holds: 0

Enhanced descriptions from Syndetics:

For the quality assurance professional who is responsible for monitoring compliance with legal requirements and accepted standards and guidelines, this volume covers the specialized procedures and techniques comprised by the disciplines of good laboratory practice, good clinical research practice, and good manufacturing practice. Annotation copyrighted by Book News, Inc., Portland, OR

Bibliography: (pages 373-382) and index.

Part One: Background -- An introduction to good laboratory practice (GLP) / R D Broad and N J Dent -- GLP legislation / K W G Shillam -- Overall responsibilities for GLP / P D Lepore -- Part Two: The quality assurance program -- The master schedule / J E Goeke -- The study plan / P R Cooper -- Standard operating procedures / N Gawadi -- Procedural inspections / R Kaplan -- Process inspections / D S Goldman -- Facilities inspections / A Waddell -- Data audits / J Birnie -- Report audits / D L Colinese -- The QA statement / S Trenchard-Morgan -- Archives / R G Lawrence -- Staff records / S J Harston -- Part three -- Quality assurance unit / J Maple -- QA and contract houses / D J Ford -- Computer auditing / J B Doherty -- Statistics for QA auditors of GLP and GCP studies / I J Townshend -- GLP in the analytical laboratory / M F Turner -- QA and GLP in pathology / G Falconi -- GLP in drug metabolism and pharmacokinetics / N J Dent -- GLP and QA in ecotoxicology/ H R Roderick -- Training and awareness of GLP and GCP / H Neal -- GLP compliance monitoring procedures / M de Barros -- Laboratory accreditation:the role of NAMAS and its collaboration with the UK GLP monitoring unit / B Broderick and J Beaumont -- QA in good clinical research practice / G F Moss -- QA in good manufacturing practice / G F Moss.

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