Published: October 2011
|Formats||Member Price||Nonmember Price|
|Bound Version||$145 / €135||$460 / €400|
|Individual Download||$145 / €135||$460 / €400|
|Which format is right for me?|
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.
This free document explains the relationship between the following ISPE Guides.
Accepting Nominations for 2017-2019 International Board of Directors
Monday, 27 Mar 2017 14.03
Data Integrity: Do You GAMP?
Friday, 24 Mar 2017 13.03
Nominate Your Facility for 2018 Facility of the Year Awards
Thursday, 23 Mar 2017 18.03