Medical Devices 2011 - Software Verification and Validation Planning and Execution

Why Should You Attend:
Software and related hardware design, development, verification and validation is difficult to manage, document and control. Where as Software design and development is under increased scrutiny by the new "tougher" U.S. FDA. This is with good reason. Product, production / test equipment, and even the QMS are increasingly software / firmware driven.

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.

Areas Covered in the Seminar:

Discussion on Recent industry failures.
Tougher FDA Expectations / Requirements.
Roles of Verification and Validation.
An FDA "Model".
A Typical Software V&V Protocol / Test Report.
A Brief Overview of 21 CFR Part 11.
Legacy, Hybrid, New and ER / ES Systems.
Expected Regulatory Deliverables.
Complementary Guidelines, e.g., GAMP.

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