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Risk Management
€ 99.00
net
€ 117.81
  19% VAT included
PDF-Download
US$
149.00
established methods of risk analysis
incl. ICH Q9
122 Pages
ISBN: 978-3-943267-11-2
   x
Excerpt from the GMP MANUAL

It is an effort to look systematically at the critical steps of a process by using established methods of risk analysis, e.g. FMEA or HACCP. With the publication of the ICH Q9 in November 2005 risk management became an intensive discussed topic worldwide. The implementation of risk management in a company promises to select between significant and less important steps and thereby reduce the efforts to an acceptable minimum.

Apart from describing content you will find many tables, examples, forms, which can be used in the daily practice.

Table of contents:

- Risk Management Process
- Risk Management and Quality Management System
- Methods of Risk Management
- Fault Tree Analysis (FTA)
- Failure Mode Effects Analysis (FMEA)
- Application example of a combined FTA an FMEA
- Hazard Analysis of Critical Control Points (HACCP)
- ICH Q9 Quality Risk Management

Full Table of Contents Risk Management.pdf

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Mario Hertlein, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

with Andreas Kaßube, Dr. Thomas Linz and Frank Till
Recommendations
Risk Assessment and Risk Management in the Pharmaceutical Industry
Risk-Based Compliance Handbook
A Process Approach to Pharmaceutical Quality Systems

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