Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration 2015 covers topics such as:
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHR
- Brief introduction to Lean Documents and Lean Configuration
- Device Master Records (DMR) content, development, and management
- Design History Files (DHF) content, development, and management
- Applying lean principles to creating, developing, and managing a DHF
- Device History Record (DHR) content, development, and management
- Applying lean principles to creating, developing, and managing DHRs
- Applying lean principles to creating, developing, and managing a DMR
Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration 2015 brings together attendees from:
- Supervisors
- Managers
- And Vice-Presidents in the areas of: R&D Manufacturing Engineering Design Assurance Quality Assurance Operations Document Control
- Directors