DHF, DMR, DHR — Principles on Lean Documents and Lean Configuration
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
This webinar applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration to these key elements of medical device documents.
Why you should 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, 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:
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500758LIVE
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