Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

  • Speaker:Jose Mora
  • Duration:90Min
  • Product Code:GRC-90553

Live Session - How it works

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Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
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  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

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If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the Recording of the Training for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Why should you attend:

If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work.

This webinar presents a new approach yet is based on solid principles and proven practices.

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 design control documents
  • Traceability Matrix
  • Applying lean document and lean configuration principles to the above
  • Bringing it all together

Who will benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control

Target  Audience: 

Design Engineers, Design Assurance, Quality Assurance

Instructor Profile 

Jose 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.

Jose 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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Available Options

Recording: Unlimited Viewing Access for 6 Months

$189

CD-DVD: Shipped within 2 working days

$279

USB - Shipped within 2 working days

$289

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$359

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$659

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