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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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November 23, 2011 |
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Center for Professional Innovation & Education (CfPIE), Los Angeles, CA
Mar. 14 & 15, 2012
This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to Validation & Verification (V&V), 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 |
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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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