ComplianceOnline

Configuring Your System for Lean Documents

Instructor: Jose Mora
Product ID: 701722
Training Level: Intermediate
  • Duration: 90 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section

Training CD

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In this Lean Document webinars understand how to configure your systems for lean documents and increase control and regulatory compliance.

Why Should You Attend:

As in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many lifescience companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner. Configuring for lean documents builds upon the principles of lean documents to bring the power of the electronic system into play.

This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance. We will builds upon the concepts of lean documents and introduces a new approach to configuring in a lean, straightforward way that let’s the electronic system do what it does best while reserving the original purpose of a document.

Areas Covered in the Seminar:

  • Definition of lean documents.
  • Problems with traditional document approach.
  • Applying lean manufacturing principles.
  • Basic Elements of Documented Information.
  • Relation of lean documents to basic elements.
  • Use of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.
  • What a lean document approach would have.
  • Preparing for an electronic document system.
  • Basic elements in electronic form.
  • Basic elements applied to various quality system documents and records.

Who Will Benefit:

This webinar will provide valuable insights to design engineers, manufacturing engineers, operations managers, quality system managers, and document control managers

  • Project leaders implementing an electronic document system
  • Functional managers
  • QA managers
  • Lean Project Managers

Instructor Profile:

Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 24 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. José worked for 10 years at Cordis Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter.

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, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership.

He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five Ss (Visual Workplace), process validation to GHSS standards, and similar approaches.

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