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



Speaker : Jose Mora

José Mora is a Principal Consultant specializing in Manufacturing Engi |  more...

Topic ID : 1329

Duration : 60 Mins

Live : Coming Soon..

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Course Description:

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.

Course Objective:

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.

Course Outline:

  • 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

Target Audience:

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

  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control