lean-documents

Using Lean Documents and Lean Configuration for DHRs, DMRs, and DHFs

Total Seats: 500

Date and Time:

March 13, 2024 10:00 AM PDT - 11:30 AM PDT

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Description

Course overview:

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and systems, many traditional document practices are artifacts of a flawed approach. Lean documents present a fresh departure from these practices while building upon proven principles.

Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled documents.

This webinar presents a fresh new approach based on lean principles that avoid many of the pitfalls of traditional ways of creating and maintaining DHFs, DMRs, and DHRs. By attending this session, you will learn how to create compliant documents (DHR, DMR, and DHF) utilizing the principles of Lean Documents and Lean Configuration.

Why should you attend?

Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs – which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on engineering and design?

This webinar presents a fresh new approach based upon solid principles and proven practices plus an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

Areas covered:

  • A brief introduction to Lean Documents and Lean Configuration
  • Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to
  • DHF, DMR, and DHR
  • Design History Files (DHF) content, development, and management
  • Device Master Records (DMR) content, development, and management
  • Device History Record (DHR) content, development, and management
  • Applying lean principles to creating, developing, and managing a DHF
  • Applying lean principles to creating, developing, and managing a DMR
  • Applying lean principles to creating, developing, and managing DHRs

Who will benefit:

Medical Device managers, design engineers, QA personnel, and lean program leaders can benefit from this training.

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

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

About the instructor:

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.

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, 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, 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-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

REFUND POLICY:

Attendees may cancel up to two working days before the course start date and the refund will be processed within two working days.

We will process/provide A refund if the webinar is canceled. Refunds will not be given to participants who do not show up for the webinar. On-demand recordings can be requested in exchange. Webinars may be canceled due to a lack of enrolment or unavoidable factors. Attendees will be notified 24 hours in advance if a cancellation occurs. Substitutions can happen anytime.

If you have any concerns about the content of the webinar and are not satisfied please contact us at care@thecomplyguide.com

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