A straightforward method for meeting FDA Requirements for Design Inputs and Outputs
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Website http://www.traininng.com/webinar/the-diom---a-straightforward-method-for-meeting-fda-requirements-fo |
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Category Educational trainings, HR professionals, Human Resource, Online trainings, Employee Relations
Deadline: November 16, 2019 | Date: November 18, 2019
Venue/Country: Online, U.S.A
Updated: 2019-09-20 14:28:05 (GMT+9)
Call For Papers - CFP
OverviewA robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.The speaker has worked on numerous design development projects in Class II and Class III medical devices as well as establishing Quality Management Systems which include easy-to-understand methods to meet design development and design control requirements. This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process.Why should you AttendBetter understanding of FDA regulations with regards to design input and outputAn organized approach in meeting design input and output requirementsA simplified way to ensure design inputs and outputs are continually maintained and trackedAreas Covered in the SessionIntroduction to the DIOM templateHow to identify your design inputsHow to categorize your design inputs and their sourcesWays in which design inputs can be verifiedCommon documents and activities used as design output evidenceAdditional requirements of design inputs and outputsWho Will BenefitQuality AssuranceRegulatory AffairsDesign EngineersManufacturing EngineersStartup CompaniesSpeaker ProfileDenise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA's "least burdensome approach" and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.
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