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New!! Software Validation Workshop: Practical Tools & Techniques

This 3 day workshop supplies attendees with practical tools and techniques for software validation for embedded device software, off-the-shelf software that is part of a device, and Quality System (Non-Device) software. It includes real life software validation examples utilizing Engineering & Software Quality "best practices." The workshop includes practical information on a variety of topics such as writing useful & testable requirements for testing, streamlining quality processes for development and validation efforts, and effective verification test procedure organization.  Roughly half of the workshop applies to medical device software and half is dedicated to the validation of non-device software.

Workshop Goals - At the end of this workshop, participants will be able to:

• Design software validation plans that build confidence in the software and comply with regulatory requirements for Device, Commercial Off-The-Shelf, and Quality System Software
• Use risk management to focus validation activities to minimize risk
• Streamline elements of the Quality System for cost-efficient software development and validation
• Select appropriate lifecycle models and synchronize validation activities for all types of software
• Write unambiguous, testable requirements
• Integrate best development engineering practices to support validation efforts
• Organize test designs, test cases, and test procedures that effectively cover requirements being verified, and that provide opportunities for review and management of the process.

Format
This 3-day workshop provides intensive coverage of the elements of software validation from an engineering and quality perspective. This highly interactive workshop includes a variety of exercises that cover validation activities at various points throughout the software lifecycle. These exercises provide participants with the opportunity to apply new information to actual software validation scenarios.

Who Should Attend?
Instruction is geared to professionals directly involved in the development and/or validation of software in the medical device industry such as R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program managers, and Process Engineers.

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