Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls requires tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents. This repetition is a major source of inconsistencies and errors.In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.
WHY SHOULD YOU ATTEND?
If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work. This webinar presents a new approach yet is based on solid principles and proven practices.
AREA COVERED
- Traceability Matrix
- Applying lean document and lean configuration principles to the above
- Bringing it all together
LEARNING OBJECTIVES
The objectives of the presentation are:
- Brief introduction to Lean Documents and Lean Configuration
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
WHO WILL BENEFIT?
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work. This webinar presents a new approach yet is based on solid principles and proven practices.
- Traceability Matrix
- Applying lean document and lean configuration principles to the above
- Bringing it all together
The objectives of the presentation are:
- Brief introduction to Lean Documents and Lean Configuration
- Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
Speaker Profile

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 controlled documents …
Upcoming Webinars

Marketing to Medicare or Medicaid Beneficiaries - What You …

Effective Onboarding: How to Welcome, Engage, and Retain Ne…




Employee Engagement, Empowerment and Motivation in Challeng…

Six Thinking Hats - Structuring Creative Thinking (Paralle…

Managing International Employee Payroll & Tax Services

2023 EEOC and Employers: Investigating Harassment and Discr…

Being Seen as a Human Resource Strategic Business Partner


Delivering Constructive Criticism - Best Practices

3-Hour Excel Automation Boot Camp: Top Ten Excel Functions …

How to Effectively Conduct Annual Employee Reviews

Self Esteem Matters: An Ethics Based Webinar for Women


New Ideas and Tools for Effective Performance Management 20…

Accounting For Non Accountants : Debit, Credits And Financi…


Effectively Handling CP 2100 letter and B Notices

Supervising a Human Error Free Environment: You can do a Lo…

Basic Accounting and Finance for the Human Resources Profes…

Compliance with Stop Payments vs Unauthorized Transactions

Finally! The New I-9 Form and The Extension of the DHS Remo…

The Most Frequent 483's for Medical Device Companies in 2022

CAPA/Root Cause Analysis: Achieving Compliance with Proper …

Secrets Of Psychology - Why People Do The Things They Do

Remaining Agile in an Ever-Changing Climate

Project Management for administrative professionals

4-Hour Virtual Seminar on FMLA BOOTCAMP: Managing Complianc…

Human Factors Usability Studies Following ISO 62366 and FDA…


Calculating Paychecks 2023 - Getting To Gross And Beyond

Succession Planning for Sustainable Small and Family Busine…