Boston Professional Events List


Live Webinar Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration


Date
May 22, 2018 - 01:00 PM - 02:30 PM
Organizer
conference Manager
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 347 282-5400

Ticket Price: $179 One Dial-in One Attendee | Corporate Live Recorded $279 One Dial In - Max 10 attendees |Group $695 Multiple locations upto 5 dial in | Recorded $249
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls requires tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents. This repetition is a major source of inconsistencies and errors.
 

Areas Covered

 

•       Brief introduction to Lean Documents and Lean Configuration
•       Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
•       Traceability Matrix
•       Applying lean document and lean configuration principles to the above
•       Bringing it all togethe

 

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 Details


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.


Event Categories
Keywords: Education




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