2014 - Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documents and Lean Configuration

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 for you. Our webinar will provide you with a different perspective and a very different approach that has hands-on application. 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.
Areas covered this session:
? 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
? Traceability Matrix
? Applying Lean Document and Lean Configuration principles to the above
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. Jose 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 José worked for 10 years at Cordis Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordis’ first PTA catheter..
Audiences that can benefit from this Program:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of R&D, Manufacturing, Engineering, Design Assurance, Quality Assurance, Operations, Document Control
Webinar Price Tags :
$ 229.00 Single Attendee
$ 749.00 Group ? Max 10 Attendees per location
$ 269.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
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