The International Regulatory Affairs Network
Process Validation for Medical Devices
26.05.2010 - 28.05.2010
Ort: Berlin, Germany
The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why you should validate.
The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why you should validate. Participants will learn how to comply with FDA regulations for validation protocols and determine the format and function of such protocols. Addressed is how to maintain adequate validation documentation systems and perform equipment qualifications, process and software validations, and evaluate the need for re-validations.
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http://www.cfpie.com/showitem.aspx?productid=089&source=swissbio
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