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GlobalCompliancePanel, Online Training, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
2013-12-04
Overview: Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to this key part of a QMS.
Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in controlled documents - 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, quality, and operations? 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 Configuration Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to controlled documents. Typical controlled documents and functions Lean principles applied to controlled documents Lean principles applied to configuration of electronic QMS software
Who will benefit:Managers, Supervisors, Directors, and Vice-Presidents in the areas of: R&D Manufacturing Engineering Quality Assurance Operations Document Control
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 29 years he has worked in the medical device 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.
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Deadline for Abstracts:
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2013-12-04
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Registration:
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Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
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E-mail:
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support@globalcompliancepanel.com
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