Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration
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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 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.
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 must attend webinar presents a fresh new approach based upon solid principles and proven practices – as well as an alternative, applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration, that avoids many of the pitfalls of traditional ways of preparing these Key Regulatory 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 Should Attend:
A must for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- R&D
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
- Lean Program Leaders
Course Director: JOSÉ MORA
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