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Failure Management in a GMP Regulated Environment

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How can occured failures be avoided in the future? Start to treat the root cause, not the symptoms! Learn how to set up a failure management system and how to use root cause analysis methods and toolscorrectly!

e-book

35 Seiten

ISBN: 978-3-95807-100-1

1st edition 2018

Lieferung sofort nach Zahlungseingang

87,00 € netto

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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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  • Quality management
  • Quality control
  • Production
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