rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Validation and qualification in analytical laboratories
  name:
    name part: Huber, Ludwig
    name part: 1948-
    role:
      role term: creator
  type of resource: text
  genre: bibliography
  origin info:
    place:
      place term: nyu
    date issued: 2007
    edition: 2nd ed.
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: print
    extent: v, 303 pages : illustrations ; 24 cm.
  table of contents: Introduction -- Regulations, standards, and guidelines -- Terminology and validation overview -- Risk-based validation and qualification -- Master and project planning for equipment and computer systems -- Design qualification -- Installation qualification -- Operational qualification -- Performance qualification and maintenance -- Special considerations for software and computer systems -- Validation of analytical methods -- Data review and validation and evaluation of uncertainty -- Handling out-of-specification situations -- (Certified) reference standards -- People -- Proficiency testing for external laboratory qualification -- Audits.
  note: Ludwig Huber.
  note: Includes bibliographical references (pages 281-297) and index.
  subject:
    topic: Analytical chemistry
    topic: Quality control
  subject:
    topic: Chemical laboratories
    topic: Standards
  subject:
    topic: Chemistry, Pharmaceutical
    topic: standards
  subject:
    topic: Chemistry Techniques, Analytical
    topic: standards
  subject:
    topic: Drug Industry
    topic: standards
  subject:
    topic: Laboratories
    topic: standards
  subject:
    topic: Quality Control
  classification: QD75.4.Q34 H83 2007
  classification: 543.068/5
  classification: QV 744 H877v 2007
  identifier: 9780849382673 (hardcover : alk. paper)
  identifier: 084938267X (hardcover : alk. paper)
  identifier: 2007020360
  identifier: http://www.loc.gov/catdir/toc/ecip0718/2007020360.html
  identifier: http://www.loc.gov/catdir/enhancements/fy0726/2007020360-d.html
  related item:
    location:
      url: http://www.loc.gov/catdir/toc/ecip0718/2007020360.html
  related item:
    location:
      url: http://www.loc.gov/catdir/enhancements/fy0726/2007020360-d.html
  record info:
    record content source: DNLM/DLC
    record creation date: 070515
    record change date: 20210508063126.0
    record identifier: in00002280194