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ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification describes how organizations can move from established baseline practice to a more efficient science- and risk-based framework. It illustrates the application of Quality Risk Management to traditional commissioning and qualification practices, linking traditional terminology and approaches to the newer science- and risk-based specification and verification terminology and approaches applied in ICH Q8, Q9, and Q10, ASTM E2500, and ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment.

The approach described in the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification allows companies to achieve the benefits of a science- and risk-based model by outlining bridging strategies for organizations with well-established qualification-based Quality Management Systems and providing a roadmap showing the spectrum of potential approaches for this transition.

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Member Price: $ 145.00 / € 115.00
Publication + Membership:** $ 424.00 / € 349.00
Non-Member Price: $ 450.00 / € 370.00

ISBN: 978-1-936379-18-7

Format: Bound

Edition: 1st

Pages: 140

Publishing Date: 10/11
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