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 …
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Understanding Artificial Intelligence (AI) & using Chat GPT
Empowering Conflict Resolution: Letting Go to Gain Control
Transform Data into Insights: A Beginners Guide to Excel Pi…
Project Management for administrative professionals
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Bootcamp for New Managers and Supervisors: Develop These Es…
Negotiating Skills For Professional Results - Winning Strat…
How to Write Effective Audit Observations: The Principles f…
How to Use ChatGPT to Write Employee Evaluations
Power BI - Getting Started Building Reports and Dashboards
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
Onboarding is NOT Orientation - How to Improve the New Empl…
How to Conduct Exit Interviews - Implementing and Enhancing…
Onboarding Best Practices for 2025: Proven Strategies to Po…
How to Give Corrective Feedback: The CARE Model - Eliminati…
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
2025 EEOC & Employers: Investigating Claims of Harassment …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
FMLA Compliance in 2025: A Comprehensive Guide & Strategies…