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    Live event Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

    View: 215

    Website https://compliance2go.com/product/?pid=CP2014-389 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: January 14, 2015 | Date: January 14, 2015

    Venue/Country: Houston, U.S.A

    Updated: 2014-11-24 16:59:41 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

    Why should you attend:

    Medical Device managers, engineers, QA personnel, as well as lean program leaders.

    Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

    Areas Covered in the Session:

    Brief introduction to Lean Documents and Lean Configuration

    Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHR

    Design History Files (DHF) content, development, and management

    Device Master Records (DMR) content, development, and management

    Device History Record (DHR) content, development, and management

    Applying lean principles to creating, developing, and managing a DHF

    Applying lean principles to creating, developing, and managing a DMR

    Applying lean principles to creating, developing, and managing DHRs

    Who will benefit:

    Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

    R&D

    Manufacturing Engineering

    Design Assurance

    Quality Assurance

    Operations

    Document Control

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    60 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.