Project Management For Non-Project Managers Series - Project Management Process In Development Of In Vitro Diagnostics

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.

Why You Should Attend:

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.

Learning Objectives:

• 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. 

Areas Covered In The Session:

• Overview of a typical IVD development process.
• IVD initiating 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

Who Should Attend:

Any member of a cross functional project team:

• Engineers
• Marketing Associates
• Product Managers
• Program Managers
• Contract Managers
• Project Managers
• Research & Development Associates, Managers, and Directors
• Manufacturing Managers
• Technicians

Anyone that participates in or has the potential to manage team-based cross-functional projects.This course crosses all industries and functions it is however particularly suited for the health sciences and other regulated industries where much project-based work is accomplished. The types of industries that are targeted include:

• Medical device manufacturers
• Pharmaceutical and Biotech organizations
• Cosmetic and foods manufacturers
• All other industries

Topic Background:

An In vitro diagnostic project manager is responsible for overseeing the development and launch of a new diagnostic product. There are many steps and processes involved in the development of an IVD product, including research and development, clinical trials, regulatory approval, and manufacturing. 

The project manager must have a thorough understanding of the project management process and how it integrates into IVD development to ensure that the project stays on track, on time, and within budget. This includes developing a project plan that outlines all the tasks and timelines necessary to complete the project successfully. The project manager must also be familiar with the regulatory requirements and standards governing IVD development, such as ISO 13485 and FDA regulations. 

This knowledge is essential to ensure that the product is developed to the required quality standards and is compliant with regulatory requirements. Additionally, the project manager must work closely with cross-functional teams involved in IVD development, including research and development, clinical affairs, regulatory affairs, and manufacturing. Effective communication and collaboration are critical for the project manager to ensure that everyone is working towards the same goals and objectives. 

A thorough understanding of the project management process and how it integrates into IVD development is critical for an In vitro diagnostic project manager to ensure the successful development and launch of a new diagnostic product.

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.