This webinar applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration to these key elements of medical device documents.
Why you should attend: 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.
AREA COVERED
- Brief introduction to Lean Documents and Lean Configuration
- Quality System Regulation, 21 CFR Part 820, 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
WHO WILL BENEFIT?
- R&D
- Manufacturing Engineering
- Quality Assurance
- Operations
- Document Control
- Brief introduction to Lean Documents and Lean Configuration
- Quality System Regulation, 21 CFR Part 820, 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
- R&D
- Manufacturing Engineering
- Quality Assurance
- Operations
- Document Control