Software Validation and its 11 Key Documents

This webinar 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 the growing field of 'cloud'-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.

Why Should You Attend:

Software design and development is under increased scrutiny by a 'tougher' U.S. FDA. Software V&V issues are becoming a growing area of concern by regulatory agencies. Product, production/test equipment, and even the QMS are heavily software/firmware driven in today's manufacturing. A comprehensive, corporate wide plan is a necessity. Growing 'cloud' issues add urgency to upgrade control. Software's complex logic pathways mandate resource-intensive V&V activities, in a resource-constrained environment, demanding a product risk-based approach. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V is necessary to minimize software failures in the field or in-house? Use the FDA's own 'model' to document all types of SW V&V. And use this model to add predictability to bring software V&V in under budget and within project timelines..

Areas Covered in the Webinar:

• Major areas of industry failure
• Tougher FDA Expectations/Requirements; Cybersecurity
• Roles of Verification and Validation
• An FDA 'Model'
• A Typical Software V&V Protocol/Test Report; 'Black' and 'White' box
• A Brief Overview of 21 CFR Part 11, and its implementation
• Legacy, Hybrid, New and ER/ES Systems
• Expected Regulatory Deliverables
• Complementary Guidelines

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Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software/firmware V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing 'cloud' environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects. This information applies to personnel/companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceutical and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering
• All personnel involved in a U.S. FDA-regulated environment. Especially those involved in the complaing handling, non-conforming material, out-of-specification, failure investigations, root cause analysis, labeling, distribution, storage, tracking, use or regulated medical products.