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 …
AI for Project Managers: Smarter Planning Reporting and Com…
Mastering Performance Management: Strategies for Continuous…
ChatGPT for Innovative Business Advisory Services for Accou…
Female to Female Hostility @Workplace: All you Need to Know
Latest Trends in Human Error Reduction in GMP Manufacturing
Bootcamp for New Managers and Supervisors: Develop These Es…
Analytical Method Validation Under Good Laboratory Practice…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Data Integrity and Privacy - Compliance with 21 CFR Part 11…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Payroll Record Keeping: How to Thin Out File Cabinets and Q…
Medical Device Cybersecurity Following FDA’s 2026 Premarket…
Construction Lending And Real Credit Administration: Evalua…
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Moving From an Operational Manager to a Strategic Leader
Launch Your Career: The Ultimate Guide for Emerging Profess…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Discover how Emotional Intelligence turns AI from a technic…
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
The 60 Minutes Introduction to DAX
Empowering Conflict Resolution: Letting Go to Gain Control
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…