Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration
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Website http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500192?expDate=Ourglocal |
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Category seminar; webinar; 21 CFR Part 820; ISO 13485; Design History Files (DHF); Device Master Records (DMR); Device History Record (DHR)
Deadline: April 21, 2014 | Date: April 21, 2014
Venue/Country: 38868 Salmon Ter, Fremont California 94536, U.S.A
Updated: 2014-03-28 15:38:14 (GMT+9)
Call For Papers - CFP
Instructor: José Ignacio MoraDescription:The Theory of Lean 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 process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened ccontrolled "paper" documents.Why Should you Attend:Medical Device managers, engineers, QA personnel, as well as lean program leaders.Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design? 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.Objectives of the Presentation:Brief introduction to Lean Documents and Lean ConfigurationQuality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHRDesign History Files (DHF) content, development, and managementDevice Master Records (DMR) content, development, and managementDevice History Record (DHR) content, development, and managementApplying lean principles to creating, developing, and managing a DHFApplying lean principles to creating, developing, and managing a DMRApplying lean principles to creating, developing, and managing DHRsWho can Benefit: Managers, Supervisors, Directors, and Vice-Presidents in the areas of:R&DManufacturing EngineeringDesign AssuranceQuality AssuranceOperationsDocument ControlView More about Producthttp://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500192?expDate=Ourglocal
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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