Software Validation Utilizing Principles of Lean Documents and Lean Configuration
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. 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 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, orthopedic 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 S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. New approaches to software validation will help avoid many of the structural costs with a major endeavor by removing legacy methods that applied to paper systems. This will also set the stage for further integration with other software systems and modules.
With the increased need to automate many Quality Management System (QMS) and manufacturing processes, as well as medical devices themselves, software validation has continued to come to the forefront in terms of design controls, process controls, supply chain management, and almost every process currently involved in medical devices.
This is happening while AI and robots continue to also proliferate in the general business, marketing, and sales arena. One the trend is that often controlled documentation is embedded into the the software itself and these may not have received the scrutiny of their paper document counterparts in terms of controls and review. With the increased burden on software from every direction, the traditional ways of configuring information are becoming obsolete artifacts of a paper-based era. A new approach to software configuration and validation is needed to set the stage for this new era of information and the internet of things (IoT).
- Software configuration
- General setup
- User Management
- Rights Groups, Roles, and Actors
- Failure Modes, Process Signals, Tasks
- Screens, menus, and modules
- Process validation steps
Course Level - Intermediate
Who Should Attend
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Manufacturing Engineering
- Design Assurance
- Quality Assuranc
- Document Control
Why Should You Attend
You will soon be overwhelmed by continuing to apply paper document methods and approaches to software configuration and validation. Rather than wait to be surprised by unexpected situations, or to implement requirements haphazardly, it is better to understand the hands-on challenges of dynamic requirements as they push the boundaries of technology and new applications.
If you are already constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, and now realize a different way is needed, this webinar is something that will give you a different perspective and a very different approach that you can use. This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.