Online Training Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration
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Website https://compliance2go.com/product/?pid=CP2014-389 |
Edit Freely
Category Medical Device
Deadline: January 14, 2015 | Date: January 14, 2015
Venue/Country: Houston, U.S.A
Updated: 2014-12-22 16:30:21 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThe 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 controlled "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.Areas Covered in the Session: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 will benefit: Managers, Supervisors, Directors, and Vice-Presidents in the areas of:R&DManufacturing EngineeringDesign AssuranceQuality AssuranceOperationsDocument ControlWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides60 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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