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Implementing a World Class Deviation Management

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In this e-book you'll find answers on how deviations are defined, what must be observed in handling deviations, who is responsible for managing deviations and what interfaces to other systems there are.

e-book

28 pages

ISBN: 978-3-95807-030-1

1st edition 2015

Delivery immediately after receipt of payment

€87.00 net

€93.09 * prices incl. VAT

Description

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Technical Requirements

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Excerpt from the GMP Compliance Adviser

In spite of qualified equipment, trained employees and validated processes, the daily routine in pharmaceuticals is rife with situations in which prescribed workflows are not observed or processes fail to deliver the expected results. For this reason it is important not only to define the workflows for production in "normal cases", but also to specify how such deviations are to be handled. This will ensure that acceptable product quality can be obtained even in the event of unforeseen circumstances.

You will learn all you need to know about

Requirements for deviation management
Workflow of deviation management
Responsibilities
Failure investigation report
Evaluations
Review of the system effectiveness
Interfaces to the CAPA system
Examples
Quotes from regulatory works

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Technical Requirements

This file is in PDF format!
Filesize: 1,03 MB

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The e-book is password protected to prevent copying and modification of content.

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