About This Course
This capstone course integrates the project management principles introduced earlier in the program and applies them to the full biotechnology product development process. You’ll examine how scientific discovery moves through development, regulatory review, clinical trials and commercialization. Working in teams, you’ll develop and present a project management plan for a biotechnology product. Your plan will incorporate core project elements, including a project charter, a work breakdown structure and strategies for managing risk, change, quality and communication in a regulated biotechnology environment.
WHAT YOU'LL LEARN
- How to define project scope and develop a detailed statement of work, communication plan and stakeholder management strategy
- How to structure project tasks, build a project network and identify the project critical path
- Methods for identifying and managing project risks and quality considerations, including regulatory and clinical development risks
- How to estimate development costs and construct a project budget for a biotechnology project
- Strategies for project monitoring, project control and effective reporting to scientific, business and regulatory stakeholders
