Software Verification and Validation Planning and Execution

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This presentation focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) software. A suggested FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches.

Software considered: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS / Pt. 11. Field examples, good and bad will be addressed. We will evaluate the chief areas of FDA concerns to see actual and anticipated changes in emphasis based on this new regulatory climate.

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