Faculty: Charles Paul | Code: PM356113
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:
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.
AREAS COVERED IN THE SESSION:
WHO SHOULD ATTEND:
Any member of a cross functional project team:
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:
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.
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.