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Failure Management in a GMP Regulated Environment
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Effective Root Cause Analysis

Excerpt from the GMP Compliance Adviser

Edition: 1st edition 08/2018
35 Pages
ISBN: 978-3-95807-100-1
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

Failure investigations are more than must-do quality tasks. They can lead to scrap reduction, rework reduction, cost cuts and process improvements. It’s important to treat the root cause, not the symptoms!

The question is therefore, how to avoid the failures that have occurred in the future. One of the key success procedures is the investigation process in a pharmaceutical company. And a failure management system is also an essential part of continual improvement.

Failure Management in a GMP Regulated Environment outlines how to set up a failure management system and explains how to use root cause analysis methods and tools correctly. The report includes:
  • Root cause analysis as a quality management system enabler
  • Root cause analysis in the product life cycle and pharmaceutical QM system
  • Reactive and proactive root cause analysis
  • Effort, rigour and formality
  • Root cause analysis as a process of continual improvement
  • Corrective actions
  • Methods and tools of root cause analysis

Order now your copy of Failure Management in a GMP Regulated Environment and avoid failures that have occured in the future!

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This file is in PDF format!
Filesize: 2,61 MB

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  • Quality management
  • Quality control
  • Production
  • Engineering
Mayer, Martin

As Vice President of Quality Assurance, Martin Mayer has been responsible for managing the quality organisations of the Global Operations Generic Drugs & Standard Solutions production sites since 2013. His areas of expertise include quality management standards, GMP compliance, inspection management and risk management.

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