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 …
Upcoming Webinars
How to Give Corrective Feedback: The CARE Model - Eliminati…
Why EBITDA Doesn't Spell Cash Flow and What Does
Improving Employee Engagement & Retention Through Stay Inte…
SOPs - How to Write Them to Satisfy those Inspectors
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Documenting Misconduct that Will Stand Up in Court
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Error Reduction Techniques for Floor Supervisors
Project Management for Non-Project Managers - How to commun…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Sunshine Act Reporting - Clarification for Clinical Research
Humane Layoffs: How to Let People Go with Compassion and De…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Understanding the Artificial Intelligence Landscape
Establishing Appropriate Quality Metrics and Key Performanc…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Is Your Culture Working For or Against Your Success? If You…
Red flags that can render your OSHA Safety Program Complete…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
The Anti-Kickback Statute: Enforcement and Recent Updates
Onboarding is NOT Orientation - How to Improve the New Empl…
FDA Technology Modernization Action Plan (TMAP) and Impact …
How to Prepare For and Host a FDA Inspection and Respond to…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Excel Power Skills: Master Functions, Formulas, and Macros …