Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry.
Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. 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.
Areas Covered In the Session:
Who will benefit:
- 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
- Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Quality Assurance
- Document Control