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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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October 16, 2012 |
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Center for Professional Innovation & Education, Inc., King of Prussia, PA
Mar 7 & 8, 2013
This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Topics to be discussed include:
The regulatory expectations for computer validation
Relevant FDA warning letters
The tasks and deliverables expected for computer validation
Why validation processes vary so much
Strategies for practical, yet defensible computer validation
Sops required for system operation and maintenance
21 CFR part 11 and it’s implications for common regulations
An active discussion of part 11 examples and audience questions
The implications of GAMP 5 on computer validation and how to transition from GAMP 4
Auditing GXP computer systems and suppliers
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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=081&source=hummolgen
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E-mail:
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info@cfpie.com
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WWW: Kai Garlipp,
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