Risk-based Software Validation for Quality System software and Medical Device Data Systems(MDDS) by Betty Lane
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Website https://compliance2go.com/product/?pid=CP2014-417 |
Edit Freely
Category Medical Device
Deadline: February 18, 2015 | Date: February 19, 2015
Venue/Country: Online, U.S.A
Updated: 2015-01-26 16:09:32 (GMT+9)
Call For Papers - CFP
DESCRIPTIONBy applying risk analysis to software validation tasks, the amount of validation effort can be based on the risk, thus reducing validation effort for low and moderate risk software. This webinar on software validation will provide you the information you need to establish as system for validating quality-related software under FDA’s Quality System Regulation/cGMP. This includes validating any software used for manufacturing and testing of medical devices and used in your quality system. In addition it will cover the approaches to validating Medical Device Data Systems software. This approach to software validation is also applicable to software used under GLP, GCP, and cGMP.Why you should attendUnder Medical Device cGMP, 21 CFR820.70 (i), software used in manufacturing or testing of medical devices or in the quality system must be validated for its intended use. 21 CFR 11, Electronic Records, Electronic Signatures, also has software validation requirements. Product software is required to be validated as part of design controls (21 CFR 820.30). The FDA has recently down-classed MDDS to Class I, but requires that these system still follow design controls, and thus software validation. This presentation will focus on how software, including MDDS, can be validated for its intended use, including how to establish procedures in your quality system to cover software validation activities.Description of the topicThis presentation will provide information on software validation necessary for quality management, as well as for quality and other engineers who design and preform software validation activities. This presentation will provide an understanding of software validation for software used under GLP, GCP, and cGMP and validation of software in MDDS products. Information will be provided to make sure your software validation system meets FDA regulations and guidelines.Developing or updating your software validation system to one based on riskComplying with FDA requirements for manufacturing, testing and quality softwareComplying with FDA requirements for validation of software in MDDS productsMethods of creating software requirements documentsPrinciples for creating a software risk analysisElements required in a software validation studyAreas Covered In the SeminarThe types of software that must be validated according to the FDA How to create or update a software validation system to meet software validation requirements in the least burdensome mannerDefining Software requirementsDefining and documenting software risk The elements of a quality system software validation programThe elements in a software validation study Who will benefitThis webinar will provide valuable assistance to all personnel in: Quality Managers and DirectorsRegulatory Affairs professionalsQuality EngineersDevelopment EngineersDesign Engineers for MDDS productsValidation engineersQuality auditorsManufacturing or Operations ManagersMedical Device IT ManagersFree documentsFDA Software Validation Slides 2010FDA Guide-Software Validation-2002FDA Guide-OTS-Software-1999FDA Guide-Cybersectrity-Networked-OTS-2005FDA MDDS Classification Rule-2011FDA-21 CFR 880.6310 MDDS-2011Webinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)60 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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