21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

The Theory of Lean Documents and Lean Configuration introduces a novel approach by applying lean principles to the creation, design, processing, and management of controlled documents typical in regulated industries. These principles challenge both traditional document practices and "push" system concepts, which are often remnants of outdated methodologies. Lean Documents offer a streamlined alternative that builds on established principles, while Lean Configuration leverages software solutions to reduce the burdens traditionally associated with paper-based systems.

Historically, before the advent of computer systems and databases, managers and quality personnel relied on elaborate visual numbering schemes, cross-referencing methods, and intricate filing systems for document retrieval and control. These systems have evolved into the complex structures seen today across the life sciences sector, including in medical device industries. Unfortunately, even with technological advancements, many companies fail to abandon these outdated legacy methods, which continue to constrain the full benefits of modern automation and information retrieval systems.

This webinar will explore how the application of Lean Documents and Lean Configuration can modernize compliance with 21 CFR Part 820, offering a more efficient and less cumbersome approach to document management in the regulated environment of medical device manufacturing.

• 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
• Basic functions found in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• Quality Management System (QMS) elements controlled via documentation
• Bringing it all together

• Quality Assurance Managers
• Regulatory Affairs Professionals
• Quality Control Specialists
• Production Managers
• Compliance Officers
• Process Engineers
• Document Control Specialists

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. José worked for 10 years at Cordis Corporation, now a Cardinal Health 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, Jose 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 S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches