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

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Website https://www.demystifiedsolutions.com/trainingDetails/Creation-of-DHFs-DMRs-and-DHRs-utilizing-the-pr | Edit Freely

Category

Deadline: March 28, 2017 | Date: March 28, 2017

Venue/Country: Online

Updated: 2017-03-09 14:54:47 (GMT+9)

Call For Papers - CFP

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 this Webinar

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

Learning Objectives

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.

Who Will Benefit

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

- R&D

- Manufacturing Engineering

- Design Assurance

- Quality Assurance

- Operations

- Document Control

For More Info, Please Click below URL:

https://www.demystifiedsolutions.com/trainingDetails/Creation-of-DHFs-DMRs-and-DHRs-utilizing-the-principles-of-Lean-Documents-and-Lean-Configuration-DEMY051428


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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