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 artefacts 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
By attending this webinar, you will learn a fresh new approach based upon the solid principles and proven practices. This webinar will also present points that can avoid many pitfalls of traditional ways of preparing documents.
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences 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. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
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