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.

Areas Covered in the Seminar:

• 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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