Design Control 2023: Project Management Utilizing Principles of Lean Documents and Lean Configuration

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:
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  • 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