Event

Validation of Computer Systems

March 8, 2012, March 9, 2012 iCal

Location: King of Prussia, PA

Course Description:

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

For more information please visit: http://www.cfpie.com/showitem.aspx?productid=081&source=lsam

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