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Webinar on “Design Inputs –Design Outputs Traceability Matrix –Principles of Lean Documents and Lean

Education

(Free Press Release) GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will conduct a webinar on the topic, “Design Inputs –Design Outputs Traceability Matrix –Principles of Lean Documents and Lean Configuration” on June 18. José Mora, a Principal Consultant will be the speaker at this session.

Webinar on “Design Inputs –Design Outputs Traceability Matrix –Principles of Lean Documents and Lean


      

Description:

Almost any industry that applies design controls is invariably up against a wall when it comes to Design Inputs, Design Outputs, and Traceability matrices. Why this is so is that these require the creation of duplicate information across many documents. The result can be one of duplication of work and loads of confusion.

The principles of Lean Documents and Lean Configuration are a solution to this problem.  These principles go a long way in helping professionals understand ways by which design controls pertaining to Design Inputs, Design Outputs, and Traceability matrices can be simplified and made easier to implement.

Participants of this webinar will have a proper understanding of how these principles can make them take a fresh look out of the usual cumbersome and repetitive processes that the Design Inputs, Design Outputs, and Traceability matrices aspects of design controls are. They will be less confused about these aspects. Their design and manufacturing resources will be able to spend much less time on documentation and on engineering and design.

This session covers the following areas:

o Brief introduction to Lean Documents and Lean Configuration

o Quality System Regulation, 21 CFR Part 820, and ISO 13485 as these apply to design control documents.

o Design Inputs – User Requirements Specification; Technical Design Requirements

o Design Outputs – Specifications, Drawings, Documents

o Traceability Matrix

o Applying lean document and lean configuration principles to the above

o Bringing it all together

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When: June 18, 10:00 AM PDT | 01:00 PM EDT

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By whom: 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.

 

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles.

 

Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Trego, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S’s (Visual Workplace), process validation to GHSS standards, and similar approaches.

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For whom:

The webinar 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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Duration: 60 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ph: 800-447-9407

 

Fax: 302-288-6884




Webinar on “Design Inputs –Design Outputs Traceability Matrix –Principles of Lean Documents and Lean

Source: Press Release

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