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 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 …
Upcoming Webinars
Effective Communication: Ensuring Clarity, Accountability a…
2-Hour Virtual Seminar on Workplace Investigations 101: How…
AI for Excel Professionals: Enhancing Productivity with Cha…
Employers Should Prepare for Immigration Raids in 2026! Thi…
The Importance of the first 5 seconds when presenting
Negotiating Skills For Professional Results - Winning Strat…
Validation Statistics for Non-Statisticians
Workplace Behavior in 2026: Tackling Conflicts and Incivili…
FDA Recommendations for Artificial Intelligence/Machine Lea…
Interactive dashboards & analytics in Excel
Bootcamp for New Managers and Supervisors: Develop These Es…
Enhancing Project Management with Storytelling Techniques
4-Hour Workshop on Data Simplified: Sorting and Filtering, …
Creating Your 2026 Marketing Strategy
The Language of Leadership: Is Your Communication Style As …
ChatGPT for Innovative Business Advisory Services for Accou…
Utilizing A Proven Process When Conducting Sensitive, Inter…
How to Write Procedures to Avoid Human Errors
Human Factors Usability Studies Following ISO 62366 and FDA…
Why EBITDA Doesn't Spell Cash Flow and What Does?
Mastering DAX Patterns in the Era of AI & Copilot
Establishing Appropriate Quality Metrics and Key Performanc…
IRS Form 1099 Reporting: Compliance Requirements
FDA QMSR Explained: How the QMSR Replaces the QSR
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Understanding EBITDA – Definition, Formula & Calculation
Tattoos, hijabs, piercings, and pink hair: The challenges …
FDA Compliance And Laboratory Computer System Validation
Medical Device Hazard analysis following ISO 14971
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…