Project Management for Non-Project Managers - The Project Management process in the development of In Vitro Diagnostics

Effective project management is essential in the development of In Vitro diagnostics. It ensures the timely completion of the project, and the efficient use of resources, coordination of teams, risk management, and quality management.

By doing so, project management helps organizations to develop high-quality IVD products that meet regulatory requirements and customer needs. This webinar will examine and explain those concepts as they relate to IVD development.

Why Should You Attend:
Project management is critical to the development of In Vitro diagnostics (IVD) as it enables the efficient and effective coordination of the various tasks, resources, and stakeholders involved in the development process. Here are some of the key reasons why project management is important in the development of IVD:

• Timely completion of the project: The development of IVD requires a significant investment of time, resources, and expertise. Project management ensures that the development process is completed within the expected timelines, thus avoiding delays in the launch of the product, and enabling the organization to gain a competitive advantage
• Coordination of resources: IVD development involves the collaboration of multiple teams, including scientists, engineers, regulatory experts, and manufacturing personnel. Project management ensures that these teams are well-coordinated and work together seamlessly towards the common goal of developing a high-quality IVD product
• Efficient use of resources: Developing an IVD product involves a significant financial investment. Project management ensures that the resources are used efficiently and effectively to maximize the return on investment
• Risk management: The development of IVD is a complex process that involves numerous risks. Project management enables the identification, assessment, and mitigation of risks, reducing the likelihood of potential delays, cost overruns, and quality issues
• Quality management: Project management ensures that quality is at the forefront of the IVD development process. It enables the development of a comprehensive quality management plan that outlines the quality objectives, procedures, and controls required to ensure that the product meets the regulatory requirements and customer needs

• Explain the typical IVD development process
• Explain how the project management process integrates into and complements the IVD development process
• Explain the importance of communication to the project management process, particularly to the development of IVD products
• Explain the importance of risk management to the project management process, particularly to the development of IVD products
• Explain the importance of the product concept definition step and why it is most often overlooked

• Overview of a typical IVD development process
• IVD initiating the process
• Product ownership during development
• Product clarification
• Target market and regulatory jurisdiction
• Resource availability
• Stakeholders and their roles
• Product concept definition
• Feasibility
• Development - Working in a design control environment
• Design and development plan
• Risk management
• Role of communications

• Engineering
• Research & Development
• Technical Services
• Supply Chain
• Regulatory Compliance
• Operations