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

Essential Metrics to Measure Accounts Receivable Health

Bad Standard Operating Procedures (SOPs) - Bad Training: Ga…


Three Key Risk Assessments in Your ERM Program - ERM IT and…

HR Metrics & Analytics 2022: Update on Strategic Planning, …

Recent UPDATES to the Rules Stop Payments vs Unauthorized E…

Financial Projections for Determining Long-Term Cash Flow R…

Data Modelling and Analysis with Excel Power Pivot


Impact Assessments For Supplier Change Notices

How to Write Contracts for Procurement Professionals

FDA Regulation of Artificial Intelligence/ Machine Learning

Stay Interviews: A Powerful Engagement and Retention Tool



Harassment, Bullying, Gossip, Confrontational and Disruptiv…





FORM I-9 2022: ICE Announces New Extension Date and Require…

Establishing a Robust Supplier Management Program

Travel and Expense Policy Development and Automation

With Mandatory Paid Leave Gaining Ground, Is It Time To Do …

Project Management for Non-Project Managers



Implementing an Effective Human Error Reduction Program

How to prepare an effective audit manual for an internal au…

CMO Supplier Quality Agreements: How to Comply with new FDA…


Form 1099 Update 2022: Latest Forms, Rules and Reporting Re…

21 CFR Part 11 - Compliance for Electronic Records and Sign…

Managing Toxic & Other Employees Who have Attitude Issues

The Importance of Packaging and Labeling in Pharmaceutical …

I-9 Audits: Strengthening Your Immigration Compliance Strat…


The Top Ten Excel Functions Everyone Should Know