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Qualifizierung und Validierung im Labor. Ein Handbuch für Equipment und Prozesse: Mit Fallbeispielen, Templates und einem Pharmatechnik-Wörterbuch.
Paperback
Publisher: Independently Published
Published: Oct 12 2025
Pages: 214
Weight: 0.84
Height: 0.45 Width: 7.00 Depth: 10.00
Language: German
Dieses Werk ist Ihr unverzichtbarer Begleiter für die erfolgreiche Umsetzung von Validierungsprozessen im Labor.
Von den grundlegenden Prinzipien bis zur dauerhaften Qualitätssicherung - dieses Handbuch führt Sie systematisch durch jeden Schritt des Validierungslebenszyklus. Sie erfahren, wie Sie die Einhaltung regulatorischer Anforderungen nicht als Hürde, sondern als wesentlichen Bestandteil Ihrer Arbeit begreifen.
In diesem Buch erfahren Sie, wie Sie:
den strategischen Validierungs-Masterplan (VMP) als Fundament Ihrer Arbeit erstellen.
Ihre Labore und Ausrüstung nach internationalen Standards qualifizieren (IQ, OQ, PQ).
analytische Methoden präzise validieren und deren Zuverlässigkeit nachweisen.
den validierten Zustand durch ein effektives Änderungsmanagement langfristig aufrechterhalten.
von praxisnahen Fallbeispielen und sofort einsetzbaren Templates profitieren, um die Theorie direkt in die Praxis umzusetzen.
Ob Sie ein erfahrener Qualitätsmanager, ein aufstrebender Labortechniker oder ein Student sind, der die Materie von Grund auf verstehen möchte - dieses Buch liefert Ihnen das nötige Praxiswissen. Es wurde geschrieben, um Ihnen die Werkzeuge an die Hand zu geben, die Validierung nicht als Last, sondern als Chance zur Sicherung von Qualität und Integrität Ihrer Arbeit zu begreifen.
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