online event creation of dhfs, dmrs, and dhrs utilizing the principles of lean documents and lean...

8/10/2019 Online event Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

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"Creation of DHFs, DMRs, and DHRs utilizing the principles of

Lean Documents and Lean Configuration"

Industry: Medical DeviceSpeaker: Jose MoraProduct Code: CP2014-389Wednesday January-14-2015 01:00 PM | 02:00 PM - EDT , 60 Minutes

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 regulatedindustries. Just as lean principles challenge traditional process concepts and "push"systems, many traditional document practices are artifacts of a flawed approach. Leandocuments presents a fresh departure from these practices, while building upon provenprinciples. Lean configuration comes from the same principles, utilizing the uniquepower 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 theinformation found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, andchained together in a cumbersome way? Do you find that your design and manufacturingresources are spending way too much time on documentation and not enough onengineering and design? This webinar presents a fresh new approach based upon solid

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http://www.compliance2go.com/product/?pid=CP2014-389


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principles and proven practices - as well as an alternative that avoids many of the pitfallsof 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

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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

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Availabe Purchase Formats:

LIVE

$189 One Dial In - One Attendee

$249 One Dial In - Unlimited attendance (To bearranged in a Conference room/Meetingroom. Note : Only One Dial In Allowed)

COMBO

$329 Combo 1 (One Dial In - Unlimited

attendance + On Demand RecordedSession)

$349 Combo 2 (One Dial In - Unlimitedattendance + Training CD)

RECORDED

$239 On Demand ( 90 Days of online Streaming

access available after the live session )

$279 Play Back - Unlimited Views ( Recordedfile available for download after the live

session )

$299 Get Training CD

MULTIPLE LOCATION

$499 Multiple location - Up to 5 Dial in allowed

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technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints,Lean Manufacturing, Five S (Visual Workplace), process validation to GlobalHarmonization Task Force standards, and similar approaches..

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