Overview
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.
Why you should 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 what 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.
Areas Covered in the Session
Review of Lean Documents and Lean Configuration concepts
Overview of Software Validation:
- Software configuration
- General setup
- Organization
- User Management
- Rights Groups, Roles, and Actors
- Products
- Processes
- Failure Modes, Process Signals, Tasks
- Screens, menus, and modules
- Process validation steps
Who Will Benefit
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- R&D
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
Speaker Profile
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 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 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 Ss (Visual Workplace), process validation to GHSS standards, and similar approaches.
Instructor
Jose Mora