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Project Management for Regulatory Professionals [4.0 RAC]

4.0 RAC Credits Member: $465 Nonmember: $640
Project Management for Regulatory Professionals [4.0 RAC]
Commonly used in engineering and IT applications, project management principles, tools and techniques also can be used for better planning, control, monitoring and review of project tasks in the regulatory profession. The regulatory profession is well-suited for adopting project management practices; regulatory projects are usually complex, time-constrained and resource-intensive. Although product development encompasses the same global components (Chemistry Manufacturing & Controls (CMC), preclinical, clinical), each product is unique, requiring that data and/or methods be generated, encountering specialized issues, and demanding an individualized domestic and/or global filing strategy. Using project management principles results in more effective use of time and resources.

This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports. The course also provides, from the project management perspective, important tips on communication and meetings, such as how to set up and run meetings and how to use meetings to advance and monitor the project effectively.

At a Glance
  • Target Audience: This course is designed for new and experienced regulatory personnel interested in learning and improving project organization and management skills.
  • Learning Level: Basic, Intermediate
  • Total Length of Course: 4 Hours
  • RAC Points: 4

Learning Objectives

Upon completion of this course, participants should be able to:
  • Outline how to incorporate project planning strategies during the development process
  • Discuss how to optimize team performance and interactions
  • Develop communication formats and information by type of stakeholder: teams, management, individuals
  • Define variance, estimate at completion and earned value, and explain why they are important measures
  • Assign resources to tasks in the plan and determine the effort and time needed by a resource to accomplish a task
  • Identify ways to build quality into a project

Lesson Titles
  • Lesson 1: Project Planning Basics––A Strategic Approach
  • Lesson 2: Resource Planning, Estimating and the Project Budget
  • Lesson 3: Communication and Meetings
  • Lesson 4: Metrics and Reporting
  • Lesson 5: Making the Project Team Effective

Enrollment Period: 12 months
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