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 …
Zero Acceptance Sampling to Reduce Inspection Costs
Project Management for Non-Project Managers - How to commun…
Why EBITDA Doesn't Spell Cash Flow and What Does?
FDA Compliance And Laboratory Computer System Validation
Workplace Investigations 101: How to Conduct your Investiga…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Human Error Trends as AI Enters GMP Operations: What QA Lea…
2026 EEOC & Employers: Investigating Claims of Harassment …
Stop Letting Toxic People Control Your Day
AI for Excel Professionals: Enhancing Productivity with Cha…
Building a High-Performance Team in 90 Days
Introduction to Microsoft Power BI Dashboards
Bootcamp for New Managers and Supervisors: Develop These Es…
Dealing with Difficult People: Managing Strong Personalitie…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Stop Letting That Difficult Person Ruin Your Day: Effective…
Reinvent Your HR Department with ChatGPT
Using Claude in Excel for Productivity, Automation & Data A…
DOL Reverses Course on Independent Contractor Rule for 2026…
FDA Technology Modernization Action Plan (TMAP) and Impact …
GROUPBY and PIVOTBY functions. Pivot table killers?
Discover how Emotional Intelligence turns AI from a technic…
Sunshine Act Reporting - Clarification for Clinical Research
FDA Recommendations for Artificial Intelligence/Machine Lea…
Cleanroom, Microbiology and Sterility Assurance Practices f…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
FDA Audit Best Practices - Do's and Don'ts
Medical Device Hazard analysis following ISO 14971
Interactive dashboards & analytics in Excel