Project Management for Non-Project Managers Series - Project Management in the Biomedical Industry

Project management in the biomedical industry involves applying project management principles and techniques to the development and implementation of biomedical products and services. Biomedical projects can range from the development of medical devices and drugs to clinical trials and research studies. Effective project management is essential for ensuring that biomedical projects are completed on time, within budget, and to the required quality standards.

The project management process in the biomedical industry typically involves the following steps:

• Planning: This involves defining the project goals, identifying the scope of the project, and creating a project plan that includes timelines, budget, and resource requirements.
• Execution: This involves the actual implementation of the project plan, which may include designing and developing products, conducting research, and running clinical trials.
• Monitoring and Control: This involves tracking project progress against the plan and adjusting as necessary to keep the project on track.
• Closing: This involves finalizing the project and delivering the products or services to the end-users.

In addition to these steps, project management in the biomedical industry also involves several specialized considerations, including regulatory compliance, risk management, and stakeholder engagement. 

Biomedical projects are subject to stringent regulatory requirements, so project managers must ensure that their projects comply with all relevant regulations and standards.

Risk management is also critical in the biomedical industry, as projects may involve significant financial investments and may impact patient safety. 

Finally, stakeholder engagement is essential for ensuring that all relevant parties are involved in the project and that their needs and expectations are met. 

This webinar will address the melding of effective project management procedures to this industry.

WHY YOU SHOULD ATTEND:

It is not possible to present a complete treatment of project management for this industry in the span of 90 minutes.  It is however possible to focus on those most critical project management aspects that are critical to the success of any project within biotechnology and the biomedical industry in general.  Project management is a critical component of the biotechnology industry, which involves the application of scientific principles to develop and manufacture products and services that can improve human health and well-being. The biotechnology industry involves complex processes and requires a high degree of precision and accuracy in project management. Without an understanding of basic PM tools and their unique application to this industry, it is not possible to effectively manage a project to successful completion.

Overall, effective project management is essential for the success of biomedical project development. By applying project management principles and techniques, biomedical companies can ensure that their products and services are developed and delivered in a timely, cost-effective, and high-quality manner.

This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

LEARNING OBJECTIVES:

• Explain the characteristics of Biomedical Products
• Gain an understanding of the diversity of the technologies within the biotechnology community to identify the importance of the application of project management approaches to product development.
• State why project management is essential to Biomedical technological development.
• Identify the specific aspects of project management that must be addressed and focused upon.

AREAS COVERED IN THE SESSION:

• Characteristics of biomedical products:
  • Complexity
  • Imperfect Knowledge
  • Safety
  • Reproducible Patient Benefits
  • Regulated Products
  • Changing Environment
  • Development Process
  • Control of Design and Quality Assurance
  • Information Technology Infrastructure
  • System Integration
  • Complex Cross-Functional Teams
  • Clinical Trials
  • Risk Management
  • Management Considerations
• Diversity of Biomedical Industries and Technologies
• Why use a Project Management Approach
  • Prioritization of Work
  • Team Focus
  • Supply Chains
  • Product Lifecycle Control
  • Processes
  • Flexibility
  • Senior Management Visibility
• Essential Project Management Considerations:
  • Project Planning: This phase is critical to the success of the project as it sets the foundation for the entire project lifecycle.
  • Risk Management: The biotechnology industry involves many inherent risks due to the complexity of the scientific processes involved. 
  • Resource Management: Effective resource management involves careful planning, budgeting, and allocation of resources to ensure that the project is completed within the specified timeline and budget.
  • Communication Management: Effective communication helps to ensure that all stakeholders are informed about the project's progress, challenges, and changes in the plan.

WHO SHOULD ATTEND:

Any member of a cross functional project team:

• Engineers
• Marketing Associates
• Design Engineers
• Product Managers
• Program Managers
• Contract Managers
• Project Managers
• Research & Development Associates, Managers, and Directors
• Manufacturing Managers
• Technicians
• Supply Chain Professionals
• Operations
• 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:

This webinar is intended for those that have a basic understanding of generic project management approaches; both traditional and agile.  The focus of this training is to gain an understanding of the how and the what of those key PM approaches and how they can provide significant benefit to biomedical project success.

VIEW COMPLETE COURSE DETAILS

Course Director: CHARLES 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.