Online Training 2015 - Creation of Unique DHFs, DMRs, and DHRs using the Principles of Lean - By Compliance Global Inc

Overview:
The Theory of Document Management system 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 present 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 Design History Files, Device Mastery Records, and Device History Records - 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?
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
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
Level:
Intermediate
For more detail please click on this below link:
https://www.complianceglobal.us/product/700059
Email: referrals-AT-complianceglobal.us
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