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This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Read more »
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Medical Devices: Understanding Risk Management in medical devices
Tue 20 September 2011 at 12:00 PM EST
Discount : Get 15 % Discount as a early bird registrations. Use Promocode CGO15 Read more »
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Why Should You Attend:
Many medical devices are controlled by software that governs key aspects of the user interface, and performs key safety functions. Users often do not realize the extent to which software determines many of the key functional and performance characteristics of the system until something goes wrong. Unfortunately, in some cases, the software does “go wrong” and compromises performance reliability and patient safety. Because software is inevitably complex, abstract, and intangible, design errors can be difficult to detect. The occurrence of a software error should be a highly unusual event. Read more »