Software Verification & Validation

Date : 22nd January 2019 to 22nd January 2019

Place : United States, Fremont

Website :https://www.traininng.com/webinar/software-verification-&-validation-200558live?allconferencealerts-seo

Contact Person:Event Manager

Description:

Overview Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. You'll come away with an actionable understanding of: Developing and creating buy-in for a project validation plan Understanding what the FDA accepts as an appropriate documentation model Beyond just in-product software V&V - understanding FDA's expectation for your testing software, ERP software and more When and how to use DQ, IQ, OQ, PQ or their equivalents How GAMP 4/5 requirements fit into your V&V planning and execution Detailing the FDA's 11 key V&V documentation elements: Level of concern Hazard/Risk analysis Software description SRS (Software Requirements Specification) Architecture Design specification Traceability (Matrix; Paragraph Numbering) Development V&V (Verification/Testing & Validation: IQ, OQ, Part 11 test cases, if required, PQs) Revision history and release number Unresolved anomalies ('Bugs')

Software Verification & Validation will be held in Fremont,United States on date 2019-01-22

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Deadline for abstracts/proposals : 22nd January 2019

Keynote Speakers : Lena Cordie has over 20 years of quality and project management experience including: 10 years in project management at Target Financial Services 11 years as Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

Conference Highlights :FDA Quality System Requirements for software FDA guidelines on software verification and validation Smart software verification methods How to design smart validation tests How to conduct black box testing and white box testing to perform thorough validation

Venue :Fremont, CA, USA

Check the event website for more details.