Mastering Project Management: Lean Documents & Lean Configuration Techniques

Is Your Project Management Truly Lean and Compliant?

Instructor :
Jose Mora

Webinar ID:
11830

Date: NOV 20, 2024 (WED)

Start Time: 10 AM PT - 11:30 AM PT

Duration: 90 Mins.

What will you learn

    • Introduction to Lean Documents and Lean Configuration Principles
    • Exploring Critical Chain Concepts in Project Management
    • Understanding Discovery Phase and Conducting Gap Analysis
    • Design & Development Plan in Definition Phase
    • Identifying and Managing Design Input for Projects
    • Establishing Design Output and Its Importance
    • Conducting Comprehensive Design Review Procedures
    • Executing Design Verification and ….
    • Introduction to Lean Documents and Lean Configuration Principles
    • Exploring Critical Chain Concepts in Project Management
    • Understanding Discovery Phase and Conducting Gap Analysis
    • Design & Development Plan in Definition Phase
    • Identifying and Managing Design Input for Projects
    • Establishing Design Output and Its Importance
    • Conducting Comprehensive Design Review Procedures
    • Executing Design Verification and Validation Processes
    • Build Phase and Design Transfer for Project Completion

Course Description

In today’s fast-paced business environment, Project Management goes beyond task coordination—it’s about effectively managing documents, records, and other critical information.

Traditional methods often involve pushing through various stages, leading to delays and inefficiencies.

This webinar introduces Critical Chain Project Management (CCPM), a methodology inspired by Eliyahu M. Goldratt’s “Critical Chain.”

Key concepts include:

    • Designing projects from the end to the beginning.
    • Managing buffers at the project level to avoid delays and accelerate completion.
    • Utilizing a pull system to streamline the project workflow.

We also explore how Lean Documents and Lean Configuration can serve as a single source of truth, eliminating waste and ensuring information remains up-to-date and relevant.

Key Highlights:

    • Aligning with FDA guidance on design controls to maintain a logical project structure.
    • Incorporating risk management principles for robust project execution in regulated industries.
    • Addressing student syndrome and traditional pitfalls through the Critical Chain methodology for proactive task management.

Join us to discover how adopting these lean principles can transform your project management approach, ensuring efficiency and success in every project phase.

Enroll Now!

In today’s fast-paced business environment, Project Management goes beyond task coordination—it’s about effectively managing documents, records, and other critical information.

Traditional methods often involve pushing through various stages, leading to delays and inefficiencies.

This webinar introduces Critical Chain Project Management (CCPM), a methodology inspired by Eliyahu M. Goldratt’s “Critical Chain.”

Key concepts include:

    • Designing projects from the end to the beginning.
    • Managing buffers at the project level to avoid delays and accelerate completion.
    • Utilizing a pull system to streamline the project workflow.

We also explore how Lean Documents and Lean Configuration can serve as a single source of truth, eliminating waste and ensuring information remains up-to-date and relevant.

Key Highlights:

    • Aligning with FDA guidance on design controls to maintain a logical project structure.
    • Incorporating risk management principles for robust project execution in regulated industries.
    • Addressing student syndrome and traditional pitfalls through the Critical Chain methodology for proactive task management.

Join us to discover how adopting these lean principles can transform your project management approach, ensuring efficiency and success in every project phase.

Enroll Now!

Why you should attend

In the evolving landscape of project management, staying ahead means embracing methods that cut through inefficiencies and address the complexities of modern projects.

Traditional approaches often lead to delays, miscommunication, and regulatory hurdles. This is where Critical Chain meets Lean Principles to revolutionize your approach to managing projects.

Key Reasons to Attend:

    • Overcome Common Pitfalls: Learn how to eliminate bottlenecks like student syndrome and avoid the common pitfalls of traditional project management, such as unnecessary delays and task-level micromanagement.
    • Streamline Documentation & Configuration: Gain insights into Lean Documents and Lean Configuration techniques that will help you create a single source of truth for your projects, reducing the waste of duplicate and obsolete information.
    • Enhance Regulatory Compliance: Equip yourself with strategies to align your project management practices with the latest regulatory standards and FDA guidance, ensuring your projects are both efficient and compliant.
    • Boost Efficiency and Results: Discover how applying Critical Chain Project Management (CCPM) can accelerate project completion, protect the critical chain, and improve overall outcomes, giving you a competitive edge in your field.
    • Practical Application: Walk away with actionable knowledge that you can apply immediately to your projects, helping you navigate complex regulatory environments, improve process validation, and effectively implement design controls.

By attending this webinar, you’ll not only master a cutting-edge project management methodology but also transform your ability to deliver high-quality results on time and within scope.

This is your opportunity to step up your project management game and become the go-to expert in your organization.

Join Now!

In the evolving landscape of project management, staying ahead means embracing methods that cut through inefficiencies and address the complexities of modern projects.

Traditional approaches often lead to delays, miscommunication, and regulatory hurdles. This is where Critical Chain meets Lean Principles to revolutionize your approach to managing projects.

Key Reasons to Attend:

    • Overcome Common Pitfalls: Learn how to eliminate bottlenecks like student syndrome and avoid the common pitfalls of traditional project management, such as unnecessary delays and task-level micromanagement.
    • Streamline Documentation & Configuration: Gain insights into Lean Documents and Lean Configuration techniques that will help you create a single source of truth for your projects, reducing the waste of duplicate and obsolete information.
    • Enhance Regulatory Compliance: Equip yourself with strategies to align your project management practices with the latest regulatory standards and FDA guidance, ensuring your projects are both efficient and compliant.
    • Boost Efficiency and Results: Discover how applying Critical Chain Project Management (CCPM) can accelerate project completion, protect the critical chain, and improve overall outcomes, giving you a competitive edge in your field.
    • Practical Application: Walk away with actionable knowledge that you can apply immediately to your projects, helping you navigate complex regulatory environments, improve process validation, and effectively implement design controls.

By attending this webinar, you’ll not only master a cutting-edge project management methodology but also transform your ability to deliver high-quality results on time and within scope.

This is your opportunity to step up your project management game and become the go-to expert in your organization.

Join Now!

Areas Covered

  • Introduction to Principles of Lean Documents and Lean Configuration
  • Principles of Project Management Based on Critical Chain Concepts
  • Discovery Phase and the Importance of Proper Gap Analysis
  • Design Control Phases for the Project:
    • Design & Development Plan as Part of the Definition Phase
    • Design Input
    • Design Output
    • Design Review
    • Design Verification
    • Design Validation
    • Design Transfer
  • Incorporating the Build Phase After Design Review as the Basis for Design Verification and Design Validation
  • Conclusions

BONUS:

    1. PDF copy of the presentation handout for your future reference.
    2. Soft copy of the certificate of completion on request.
    3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
  • Introduction to Principles of Lean Documents and Lean Configuration
  • Principles of Project Management Based on Critical Chain Concepts
  • Discovery Phase and the Importance of Proper Gap Analysis
  • Design Control Phases for the Project:
    • Design & Development Plan as Part of the Definition Phase
    • Design Input
    • Design Output
    • Design Review
    • Design Verification
    • Design Validation
    • Design Transfer
  • Incorporating the Build Phase After Design Review as the Basis for Design Verification and Design Validation
  • Conclusions

BONUS:

    1. PDF copy of the presentation handout for your future reference.
    2. Soft copy of the certificate of completion on request.
    3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Who is this course for

Everybody Benefits from Watching This. Even Better When Done as a Group!

    • Project Managers
    • Quality Assurance Managers
    • Product Development Managers
    • Regulatory Affairs Specialists
    • Process Improvement Specialists
    • Operations Managers
    • Compliance Officers
    • Design Engineers
    • Business Analysts

Everybody Benefits from Watching This. Even Better When Done as a Group!

    • Project Managers
    • Quality Assurance Managers
    • Product Development Managers
    • Regulatory Affairs Specialists
    • Process Improvement Specialists
    • Operations Managers
    • Compliance Officers
    • Design Engineers
    • Business Analysts

Instructor Profile

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 ....

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, 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 S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.

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