Ron schardong fresenius medical care

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Shitamoto, Gurumoorthi. Qualifying the vendor then applying risk to the feature level allows for much less documented verification activities. As risk increases, scale as appropriate. Feature is enabled through the setting of parameters without changing the code of the software High Death, life-threatening harm, or irreversible damage to a patient. Example: Batch release system has direct patient impact will focus. Risk modeling begins with idea that automation is a benefit and considered lower risk and not immediately assumed high risk From a regulatory perspective, tools used to conduct non-product CSV activities do not need to be validated in support of validation process. Leverage testing by the vendor to further scale validation effort.

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  • Ron Schardong. Sr. Director - Technology Quality - CSV at Johnson & Johnson. Cincinnati, Ohio Area. Hospital & Health Care.

    Johnson & Johnson.

    Fresenius. View the profiles of professionals named Schardong on LinkedIn. There are 20 Ron Schardong Past, Quality Engineer at Fresenius Medical Care.

    Ron Schardong's email address r******@ | Show email & phone >>> Work, Quality Engineer @ Fresenius Medical Care. Education, MBA in.
    To make this website work, we log user data and share it with processors. Intention of assurance activity is not to establish evidence for an auditor. Required data for Initiation is recorded prior to completion of NC Initiation task. Encourage the structured electronic capture of evidence vs paper documentation, screen shots or scanned paper.

    Guidance development centered on this software category.

    images ron schardong fresenius medical care
    Ron schardong fresenius medical care
    Reduced Technical Debt: Technical Debt is decreasing due to inclusion of automation and Continuous Integration in development. If NC is initiated for product outside of firm s control, the system prompts user to identify if a product recall is needed.

    Your assignment: Provide comments to the Docket! Basic assurance is ok. Will have the capability to assign trainings to users per training curriculum assigned by management 3.

    Center for Devices and Radiological Health (CDRH). U.S. Food and John Murray.

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    Fresenius Medical Care Bill D'Innocenzo Ron Schardong. Medtronic. Get Ron Schardong's email address, r****[email protected] Quality Engineer @ Fresenius Medical Care Not the Ron Schardong you are looking for? Fresenius Medical Care. Marc Koetter. Company. Name. Johnson and Johnson. Dana Guarnaccia. Johnson and Johnson. Ron Schardong. Lantheus Imaging.
    Basic assurance is ok. Use ad-hoc testing. Search for. Improved Product Quality: Quality is improving due to test-first development and ease of instantly performing regression testing.

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    Reduced Audit Burden: Customer audits and risk-based validation cycles are decreasing due to availability of electronic test records. Risk-based Computer Systems Validation.

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    Formalized the extent to which a favorable audit can be leveraged.

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    Use Unscripted testing. These features have Low patient risk, Medium quality systems risk. Requirement validated through positive scripted testing. Performed retrospective analysis of projects to provide empirical data Shitamoto, Gurumoorthi.

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    We discovered fundamental barriers that FDA could work with industry to address, outside of the Case for Quality. Scripted Testing Custom Feature requires programming or change to software code.

    Fresenius Medical Care Marc Koetter. Company. Name. Johnson and Johnson.

    images ron schardong fresenius medical care

    Dana Guarnaccia. Johnson and Johnson. Ron Schardong. Medtronic.

    Johnson Dana Guarnaccia Johnson and Johnson Ron Schardong Medtronic. Fresenius Medical Care Curt Curtis Siemens PLM Thorsten Ruehl Fresenius. Worked At. Johnson & Johnson IncJohnson & Johnson Development Corporation. + 1 moreFresenius Medical Care North America- less.
    Will have the capability to assign trainings to users per training curriculum assigned by management 3. Size: px. This reduces a firm s capability to learn, react to issues, and improve product quality.

    Encourage the structured electronic capture of evidence vs paper documentation, screen shots or scanned paper. A separate 21 CFR 11 validation is not necessary. Shitamoto, Gurumoorthi.

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    Enforce that raw materials are not expired.

    Size: px. For feature 6, this has a Low patient safety risk, High quality system risk. Risk Based Assurance: Makes sure the system does no harm and address functions, features, and intended uses that impact patient safety and product quality.

    This reduces a firm s capability to learn, react to issues, and improve product quality. Review and possibly modify i improve clarity on automated processes Promoting recommendations through recorded Webinar:

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