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.
Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
Prior to computer systems and databases, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences.
As is often the case, automation and computers do not always replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.
Unfortunately, that is the case in 99.9% of all life science companies. The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these document systems.
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.
Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
Prior to computer systems and databases, managers and quality personnel created complex visual numbering systems and separate files for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences.
As is often the case, automation and computers do not always replace the legacy policies and rules that were necessary with manual and paper systems but are now obsolete.
Unfortunately, that is the case in 99.9% of all life science companies. The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these document systems.
Speaker
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.
Who Should Attend
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:- R&D
- Manufacturing Engineering
- Design Assurance
- Quality Assurance
- Operations
- Document Control
