Engineering Change Control Process Utilizing Principles of Lean Documents and Lean Configuration

🎤  José Mora        |  📅  August 10, 2023   |  🕒  11 AM Eastern Time US

Why You Should Attend: Many companies struggle to manage these changes due to the many documents and elements involved as well as the role of each function.  A typical symptom is an enormous checklist that while intended to ensure compliance ends up becoming an obstacle to changes. Given the never-ending volume of information, the lean documents and lean configuration approach provides a single source of truth and streamlined data set to help create and manage the ECO process.

Description:

The ECO process is critical for ensuring the safety and effectiveness of medical devices. It helps to identify potential issues before they become problems and ensures that any changes made to the device are well-documented, approved, and validated.

Overall, the ECO process is a collaborative effort involving multiple functional areas to ensure that the change is thoroughly evaluated, implemented correctly, and compliant with regulatory requirements. Each functional area plays a critical role in the process to ensure that the device is safe and effective for patient use.

Areas Covered in the Session : 

• Introduction to principles of lean documents and lean configuration
• The ECO process flow
• Importance and expectations
• Typical steps in generating an ECO
• Role of each functional area in the process
• Site-specific considerations
• Summary and Conclusion

Who Should Attend: 

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Risk Management Professionals