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

Website https://worldcomplianceseminars.com/webinardetails/422 | Edit Freely

Category

Deadline: May 22, 2018 | Date: May 22, 2018

Venue/Country: Online, U.S.A

Updated: 2018-05-08 16:30:06 (GMT+9)

Call For Papers - CFP

Time: 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Description

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 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.

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