Design Control 2022 - Project Management Utilizing Principles of Lean Documents and Lean Configuration

Project Management Utilizing Principles of Lean Documents and Lean Configuration
Product Id : MD3358
Category : Food, Drugs & Biologics, FDA Compliance, Medical Devices, Quality
Presenter : José MoraScheduled On : February 08 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 90 Minutes
Project Management involves not only the management of tasks and task owners, but also of information involving documents, records, and many other elements. The traditional approach is to compile, create and push these through the various stages.
The concept of critical chain project management draws from the concepts presented in the business novel Critical Chain by Eliyahu M. Goldratt, known for Theory of Constraints (TOC), is that of a pull system where the project is designed from the end to the beginning, buffers are managed at the project level rather than the task level, and the critical chain is protected to not only avoid delays, but also to bring in the project completion as soon as possible.
Project management and its related information is also presented in the context of lean documents and lean configuration to assure a single source of truth, avoiding the unnecessary waste of duplicate and obsolete information.
The structure of projects also follows FDA guidance on design controls, assuring that project phases cascade in the logical sequence of a Design History File (DHF), brings to bear risk management principles, and other robust attributes used in a regulated industry.
On often hears of student syndrome as a reason for executing tasks at the last moment, yet as this webinar will show, this is also a result of non-lean project management and caused by traditional project management pitfalls which are avoided by using the critical chain methodology.
Why You Should Attend:
Bringing together the principles of critical chain with lean documents and lean configuration presents a new model and manifestation of project management which also serves as a platform for projects involving a Quality Management System (QMS), design controls, process validation, so that project management assures outcomes that will satisfy the ever-demanding challenges of new regulations and regulatory standards.
Areas Covered in the Session :
Introduction to principles of lean documents and lean configuration
Principles of project management based upon critical chain concepts
Discovery phase and the importance of a proper gap analysis
Design control phases for the project:
Design & Development Plan as part of Definition Phase
Design Input
Design Output
Design Review
Design Verification
Design Validation
Design Transfer
A Build Phase is included after design review as the basis for Design Verification and Design Validation
Conclusions
Who Should Attend:
QA/QC Departments
Engineering Departments
Manufacturing Departments
Operations Departments
HR Departments
R&D Departments
Risk Management Professionals
José Mora
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, orthopaedic 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 José’’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.