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Handbuch Validierung in der Analytik by Kromidas, Stavros

Handbuch Validierung in der Analytik

by Stavros Kromidas
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Book cover type: Hardcover
  • ISBN13: 9783527329380
  • Binding: Hardcover
  • Subject: N/A
  • Publisher: Wiley-Vch
  • Publisher Imprint: Wiley-Vch
  • Publication Date:
  • Pages: 762
  • Original Price: GBP 130.0
  • Language: German
  • Edition: 2. Auflage
  • Item Weight: 1402 grams
  • BISAC Subject(s): Chemistry / Analytic

Als vor mehr als einem Jahrzehnt die erste Auflage dieses Buches erschien, war Validierung für viele Laborleiter eine Herausforderung. Nun haben die Weiterentwicklungen von Methoden und die Ansprüche an die Verlässlichkeit und Übertragbarkeit von Messergebnissen die Validierung als festen Bestandteil etabliert. Damit stehen Laborleitung und Qualitätsmanagement vor den Fragen wie:

* Was muss unbedingt validiert werden und welche Aussagekraft haben Validierungsdaten?
* Was wird von wem vorgegeben und wo sind wir frei?
* Wie können wir schnell und kostengünstig, aber richtig validieren?

Die Antworten lassen sich mit der zweiten Auflage dieses Handbuchs noch besser finden. Bewährtes wurde beibehalten, wie der didaktisch wertvolle Aufbau, die zahlreichen Beispiele und Tabellen und das erheblich erweiterte Glossar.

Stark überarbeitet und erweitert wurden die Kapitel:
* Validierung in der Spektroskopie - MS, LC-MS, UV, IR und NMR
* Mikrobiologie
* Titration
* Normverfahren
* Pharmazeutische Analytik
* Computervalidierung
* Messunsicherheit

Neu aufgenommen wurden:
* Besonderheiten der Validierung in der biochemischen Analytik
* Validierung von Computeranwendungen
* Ermittlung und Angabe der Messunsicherheit
* Vergleich von Software-Tools zur Methodenvalidierung
* Die Validierungs-Tool-Box - ein Plädoyer für eine universelle und flexible Validierungsstrategie
* Prozessanalytische Technologie (PAT) und Data Mining
* Trends in der Validierung
* Standardarbeitsanweisung: Validierung und Ergebnisunsicherheit von Prüfverfahren.

Stavros Kromidas gr?ndete nach langj?hriger T?tigkeit m Verkauf von Waters Chromatography die Novia GmbH und f?hrte die Firma als Gesch?ftsf?hrer bis 2001. Seitdem ist er als selbst?ndiger Berater t?tig. Der promovierte Chemiker arbeitet seit 1978 auf dem Gebiet der HPLC und hat seit 1984 zahlreiche Trainingskurse und Workshops geleitet. Er ist Autor einer regelm igen HPLC-Kolumne in der Zeitschrift "Labo" sowie einer Reihe au?erordentlich erfolgreicher B?cher.

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