APR 05

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

   

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When:

  05 Apr 2017 through 05 Apr 2017

Where:

  Online Event

Website URL:

  https://goo.gl/kOwhZF

Sponsoring organization:

  Compliance Global Inc

Categories:

  Medicine & Health > Medical-Speciality

Cloud tags:

Event description:

Overview: 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 artefacts 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 this Webinar: Brief introduction to Lean Documents and Lean Configuration Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DHR Design History Files (DHF) content, development, and management Device Master Records (DMR) content, development, and management Device History Record (DHR) content, development, and management Applying lean principles to creating, developing, and managing a DHF Applying lean principles to creating, developing, and managing a DMR Applying lean principles to creating, developing, and managing DHRs Learning Objectives: By attending this webinar, you will learn a fresh new approach based upon the solid principles and proven practices. This webinar will also present points that can avoid many pitfalls of traditional ways of preparing documents. Who Will Benefit: Managers, Supervisors, Directors, and Vice-Presidents in the areas of: R&D Manufacturing Engineering Design Assurance Quality Assurance Operations Document Control Speaker Profile: 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. For more detail please click on this below link: https://complianceglobal.us/product/700660/JosMora/dhr-dmr-dhf-training/1 Email: referrals@complianceglobal.us Toll Free: +1-844-746-4244 Tel: +1-516-900-5515 Fax: +1-516-900-5510

Posting date:

01 March 2017
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