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ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment (FSE)



The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers.

A new ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment has been published that provides direction to industry on the implementation of a science- and risk-based approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems, equipment, and associated automation are fit for intended use and comply with regulatory requirements.

This publication is also available for immediate download.



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Member Price: $ 200.00 / € 155.00
New Member Price:** $ 469.00 / € 374.00
Non-Member Price: $ 495.00 / € 395.00
Item #IGFSEUS

ISBN: 978-1-936379-08-8

Edition: 1st

Pages: 120

Publishing Date: 06/11
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