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 is a webinar that 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
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 is intended for senior attendees with responsibilities in:
- Manufacturing Engineering
- R&D
- Quality Assurance
- Design Assurance
- Document Control
- Operations
- Lean Program Leaders
