Duration: 90 Minutes


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Project management involves not only the efficient and effective management of tasks, but also the gathering and control of relevant information. The traditional approach is to compile, create, and push these items through various stages.

The concept of critical chain project management applies the concepts presented in the business novel Critical Chain by Eliyahu M. Goldratt, known for his Theory of Constraints (TOC), which is a pull system where the project is designed from the beginning to the end, buffers are managed at the project level rather than task level, and the critical chain is protected so that it does not get stuck and delays projects completion.

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.

Often blamed for student syndrome, project management pitfalls such as non-lean methods and lack of planning are actually caused by traditional project management techniques. This webinar will show you how to avoid these common problems with the help of 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

Course Director: 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.