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    "Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) ? Principles on Lean Documents and Lean Configuration"

    View: 7

    Website https://compliance2go.com/product/?pid=CP2014-335 | Want to Edit it Edit Freely

    Category Medical Device

    Deadline: July 23, 2014 | Date: July 23, 2014

    Venue/Country: online, U.S.A

    Updated: 2014-07-05 14:07:58 (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 ccontrolled "paper" documents.

    Why Should you Attend

    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.