- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
Design control process involves 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 process and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents.
In this webinar, we apply the Theory of Lean process 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.Click to View the Pricing Plan
- 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
- Bringing it all together
This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.
WHO WILL BENEFIT
- R&D Managers, Supervisors, Directors, and Vice-Presidents
- Manufacturing Engineering Managers, Supervisors, Directors, and Vice-Presidents
- Design Assurance Managers, Supervisors, Directors, and Vice-Presidents
- Quality Assurance Managers, Supervisors, Directors, and Vice-Presidents
- Operations Managers, Supervisors, Directors, and Vice-Presidents
- Document Control Managers, Supervisors, Directors, and Vice-Presidents
José 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 and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa's business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter.
His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as "tops" by the UK Department of Health and Social Services (DHSS) during one of their intensive audits.
José managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under José's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.