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

Charles H. Paul Instructor:
Charles H. Paul
90 Minutes
Webinar ID: 501166

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Price Details
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


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

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 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

Who Will Benefit:
  • Engineering
  • Research & Development
  • Technical Services
  • Supply Chain
  • Regulatory Compliance
  • Operations

Speaker Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

He has dedicated his entire professional career explaining the benefits of performance-based training

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