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 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

Senior attendees with responsibilities in:

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