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.
Jose Ignacio Mora
Jose 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 specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of …
Leadership: Strategic Planning and Decision Making
The Top Ten Excel Functions Everyone Should Know
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Empowering Conflict Resolution: Letting Go to Gain Control
Retention Starts Here: Stop Losing Your Critical Talent and…
Gossip-Free: Leadership Techniques to Quell Office Chatter
California Meal and Rest Breaks: What You Don't Know Can Co…
Managing Difficult Employee Conversations
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Workplace Investigations 101: How to Conduct your Investiga…
Copilot and HR: An Introduction for HR Professionals
Excel Power Skills: Master Functions, Formulas, and Macros …
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Bootcamp for New Managers and Supervisors: Develop These Es…
Stress, Change And Team Resilience Through Humor: An Intera…
Is Your Workforce Change Ready? A Leader’s Guide to Quickly…