Why Should You Attend:
It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the system, system owners and network administrators are unsure on how to document initial set-up and manage changes. This seminar will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.
What participants will learn:
Who Should Attend:
Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber's website: www.ludwig-huber.com
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