BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T235846Z UID:aff0be87-8cfd-4091-af05-1d1175925572 DTSTART:20201209T083000 DTEND:20201210T083000 CLASS:PRIVATE DESCRIPTION:
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nREGISTER TODAY!
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\n\nThe nature o f documents that govern the design and manufacturing of medical devices ar e often redundant\, repetitive\, and cumbersome\, and do not work well as a business process to properly support and realize the gains made in lean manufacturing.
\n\nDesign History Files (DHFs)\, Device Master Recor ds (DMRs)\, and Device History Record (DHRs) are examples of three documen ts and files that are very closely related\, yet create many problems and inconsistencies in their management\, preparation\, use\, storage\, and re trieval.
\n\nThe information found in Design Input Design Output tra ceability matrices often must be repeated in other documents in a way that creates the risk of errors or inconsistencies. These lead either to exces sive non-value-added waste\, or even worse\, deficient products and proces ses.
\n\nMedical device manufacturing plants have the additional res ponsibility to ensure that each and every step of the manufacturing proces s is controlled by work instructions\, SOPs\, set-up instructions\, equipm ent maintenance\, and support functions\, and that evidence of this work i s maintained in controlled records.
\n\nThis seminar presents a new approach that is based on solid principles and proven practices. During th is seminar\, the Theory of Lean Documents and its corollary applied to lea n configuration will be applied in order to construct\, write\, and config ure the types of documents and records necessary for medical device design and manufacturing.
\nUpon completing this course participants should: p>\n\n
This course is designed for people tasked with maintaining and improving 21 CF R 820 Quality Systems for medical device manufacturers. This includes indi viduals that have ISO 13485 Quality Management System responsibilities for making general improvements in their organization&rsquo\;s performance sp ecifically related to Corrective and Preventive Actions (CAPA) as well as manufacturing operations. Following personnel will benefit from the course :
\n\nThe Theory of Le an Documents is the product of applying lean principles to the creation\, design\, process\, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional pro cess concepts and "\;push"\; systems\, many traditional document p ractices are artifacts of a flawed approach. Lean documents present a fres h departure from these practices while building upon proven principles. Le an configuration comes from the same principles\, utilizing the unique pow er of software solutions to take over functions that had previously burden ed controlled "\;paper"\; documents.
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EAKER
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Jose Mora is a Principal Consultant specializing in Manufacturing Enginee ring and Quality Systems. For over 30 years Mr. Mora has worked in the med ical device and life sciences industry specializing in manufacturing\, pro cess development\, tooling\, and quality systems. Prior to working full ti me as a consulting partner for Atzari Consulting\, 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. During that time he p repared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for str ategic deployment.
\n\nJose led the launch of manufacturing at a sta rt-up urology products company as Director of Manufacturing for UroSurge\, Inc. at the University of Iowa&rsquo\;s business incubator park in Coralv ille\, IA\, creating a world-class medical device manufacturing operation\ , with JIT\, kanban systems\, visual workplace and lean manufacturing prac tices. José\; worked for 10 years at Cordis Corporation\, now a John son &\; Johnson company\, where he led the successful tooling\, process development and qualification of Cordis&rsquo\; first PTA (percutaneous t ransluminal angioplasty) catheter. His medical device experience includes surgical instruments\, PTA &\; PTCA dilatation and guiding catheters\, plastic surgery implants and tissue expanders\, urology implants and devic es for the treatment of incontinence\, delivery systems for brachytherapy\ , orthopedic implants and instruments\, and vascular surgery grafts and te xtiles. During his time at Cordis\, José\; managed the Maintenance a nd Facilities Department\, taking that operation to a level rated as &ldqu o\;tops&rdquo\; by the UK Department of Health and Social Services (DHSS) during one of their intensive audits.
\n\nJose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers\, a tea m that took the Cordis Guiding Catheter business to lead the market\, brin ging 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 Jose&rsquo\;s leadership. He was also i nstrumental 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 i ntroducing world-class methodologies such as Kepner-Tregoe\, Taguchi techn iques\, Theory of Constraints\, Lean Manufacturing\, Five S (Visual Workpl ace)\, process validation to Global Harmonization Task Force standards\, a nd similar approaches.
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\n\nPlease contact the even
t manager Marilyn below for the following: \;
\n- Discounts for r
egistering 5 or more participants.
\n- If your company requires a pri
ce quotation.
\nEvent Manager Contact: marilyn.b.turner(at)nyeventsli
st.com
\nYou can also contact us if you require a visa invitation let
ter\, after ticket purchase. \;
\nWe can also provide a certifica
te of completion for this event if required.
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\nNO REFUNDS ALL
OWED ON REGISTRATIONS \;
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\nLAN171117CEV