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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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October 18, 2012 |
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Center for Professional Innovation & Education, Inc., Los Angeles, CA
Mar 20 & 21, 2013
This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to V&V and Risk Analysis and the FDA's supplemental guidelines. An ISO perspective is offered to compliment the FDA view.
Among the topics to be discussed are: Context of V&V and Risk Analysis within the overall quality system and regulation, V&V and Risk analysis procedures, V&V methodologies, V&V strategies, types of risk analysis, risk mitigation, and methods to determine probability and severity for Risk analysis.
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Organized by:
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Center for Professional Innovation & Education, Inc. |
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Invited Speakers:
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Contact info@cfpie.com for a list of course instructors
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Deadline for Abstracts:
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n/a
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Registration:
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http://www.cfpie.com/showitem.aspx?productid=118&source=hummolgen
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E-mail:
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info@cfpie.com
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