Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration
03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"Listen From José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry"
Theory of Lean Documents and also formulates a corresponding Theory
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and “push” systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled “paper” documents.
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 must attend webinar presents a fresh new approach based upon solid principles and proven practices – as well as an alternative, applies the Theory of Lean Documents and also formulates a corresponding Theory of Lean Configuration, that avoids many of the pitfalls of traditional ways of preparing these Key Regulatory Documents.
• Brief introduction to Lean Documents and Lean Configuration
• Quality System Regulation, 21 CFR Part 820, and ISO 13485 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
A must for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Document Control
• Lean Program Leaders
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.