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Project Management Utilizing Principles of Lean Documents and Lean Configuration
- 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
Overview of the webinar
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.
Who should attend?
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- HR Compliance
- Operations
- Manufacturing Engineering
- Quality Management
- Risk Management
- R&D Engineering
Why should you 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.
Faculty - Mr.Jose Mora
Jose Ignacio 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, Jose´ 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.