Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration 2015

Topics

• 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

Who should Attend

Attendees from:

• Supervisors
• Managers
• And Vice-Presidents in the areas of: R&D Manufacturing Engineering Design Assurance Quality Assurance Operations Document Control
• Directors