Software Verification and Validation Planning to Meet CGMP Requirements

This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.

Why Should You Attend:

Software and related hardware design, development, verification and validation is difficult to manage, document and control.

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)  and growing "cloud"-based software.  A suggested FDA model will be evaluated, implemented, with V&V documentation and test case examples.

Areas Covered in the Seminar:

• 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.

Who Will Benefit:

This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality Assurance
• Production / QAE
• Engineering, R&D, and software development and testing teams