The 11 Must-have Documents of Software Verification and Validation This webinar focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. A suggested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. Why Should You Attend: Recently a major pharma company paid a $750 M fine for poor compliance, and software V&V was one of the key contributors. 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. 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 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus will be 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 / 21 CFR Pt. 11. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate. This session 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. Areas Covered in the Webinar: Recent industry failures Tougher FDA Expectations / Requirements Roles of Verification and Validation The 11-Element FDA "Model" A Typical Software V&V Protocol / Test Report A Brief Overview of 21 CFR Part 11, ER / ES Legacy, Hybrid, New, and "Cloud" Systems Expected Regulatory Deliverables Complementary Guidelines, e.g., GAMP
Who will benefit: This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software 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. This training applies to personnel or companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include: Senior management Regulatory Affairs Quality Assurance / QAE Production Engineering, R&D, and software development and testing teams All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and equipment that are software driven, companies with quality management / MRP / ERP systems moving toward "paperless" systems, or other regulated medical products activities.
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