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

Document control under 21 CFR Part 820 is often slowed by legacy habits. This 75-minute webinar introduces Lean Documents and Lean Configuration, which apply lean principles to how controlled documents are created, designed, processed and managed in regulated industries.

Before computers and databases, quality teams relied on elaborate numbering schemes, cross-referencing and complex filing systems. Many medical device companies still carry these methods, which limit the benefits of modern automation and information retrieval. Lean Documents offers a streamlined alternative, and Lean Configuration uses software to remove burdens left over from paper systems.

You'll see how these ideas apply to design control documents, manufacturing records and QMS elements under the Quality System Regulation and ISO 13485.

• Explain the principles of Lean Documents and Lean Configuration
• Apply 21 CFR Part 820 and ISO 13485 requirements to design control documents
• Describe the basic functions of a life sciences manufacturing plant
• Identify the key controlled documents and records used in manufacturing
• Map QMS elements to the documents that control them
• Reduce redundancy in document control using lean principles

• A brief introduction to Lean Documents and Lean Configuration
• The Quality System Regulation, 21 CFR Part 820 and ISO 13485 as they apply to design control documents
• Basic functions in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• QMS elements controlled through documentation
• Bringing it all together

If managing controlled documents takes too much of your time, this session shows how lean principles can simplify creating and maintaining the documentation 21 CFR Part 820 requires, reducing redundancy so you can focus on value-added work.

It suits quality assurance and control staff, regulatory affairs, compliance officers, production managers, process engineers and document control specialists in the medical device industry.

This webinar is designed for professionals within the medical device industry who are involved in the management of quality systems and compliance. It is particularly beneficial for:
 

• 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