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Do you see a passionate career in the pharmaceutical industry? Well, you don’t need to spend huge money on career coaching. This project management training is built for beginners to excel in their careers.

This is an essential skill required to run research and development as well as the regulatory affairs department more efficiently. You can rest assured that after completing this course, you can apply all the crucial management skills to the upcoming tasks!

In addition to building your management skills, this project management course aims at focusing on the requirements of the pharmaceutical and life science industry. 

Why Should You Attend

It is not possible to present a complete treatment of project management in the span of 12-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project as well as those that are critical to pharmaceutical/biotechnology and medical device development projects. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

We have distilled the key aspects of project management into three four-hour virtual seminar segments that will logically move participants from the beginning of the project management process to the end – from initiating the project to closing the project.

This seminar 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.

The seminar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments. 

In addition, the unique challenges and requirements for both the pharmaceutical/biotechnology and medical device industries will be addressed creating a link between those requirements and the basic tenants of project management.

Training Course Agenda

DAY 01 & 02

Session Start Time : 12:30 PM EDT

# 1 – Introduction to Project Management – An Overview

  • What is a project?
  • What is project management?
  • The project manager’s role
  • What is effective project management?
  • The five stages of a project
  • The triple constraint, collaboration and flexibility
  • Project management pitfalls
  • The Project Charter
  • The Project Scope Statement
  • Determine your project’s audience members, i.e. project stakeholders, initiator, and champion(s)
  • How to work and interact with your audience
  • Project Planning - Stakeholder – Quality – Communications – Scope - Risk

#2 – Specifying the project work to be done and establish the project’s timing and resource requirements

  • Develop the work breakdown structure
  • Naming key tasks
  • Making assumptions
  • Special project situations
  • Long-term project planning
  • Displaying the work breakdown structure
  • Categorizing project work
  • What to document
  • Purpose and function of the network diagram
  • Reading and interpreting a network diagram
  • Creating the network diagram
  • Develop the initial schedule
  • Determine activity durations
  • Gaming the schedule
  • Determine team member skills that are needed
  • Estimate the human resource requirement
  • Meeting resource commitments
  • Resolve resource overloads and conflicts
  • Handling multiple projects
  • Developing the budget

 #3– Risk, the project team, project management and control

  • Risk factors and risks
  • Identifying the risk factors
  • Risk types
  • Assessing and weighing risk
  • Determine consequences
  • Develop a risk mitigation strategy
  • Develop your risk management plan
  • Organizational structures for managing projects
  • Define the key players and their roles
  • Team member roles and responsibilities
  • Assigning project tasks
  • Authority versus responsibility
  • The RACI Chart
  • Developing team operational strategies and procedures
  • Managing team activities
  • Developing your team
  • Managing team and individual team member performance
  • Working cross-culturally
  • Collaboration and flexibility – how are they executed and managed successfully
  • Scope creep and how it is managed
  • Tracking and reporting progress
  • Work-effort tracking
  • Managing the budget
  • Communicating effectively – how to make it work
  • When things go wrong – scheduling alternatives

DAY 03

  • The unique challenges and requirements of pharmaceutical/biotechnology project management
  • R & D process integration with standard PM processes
  • The project management success factors for project managers in the pharmaceutical and biotechnology industries
  • The unique challenges and requirements of pharmaceutical/biotechnology project management
  • Project challenges in medical device design
  • Design controls and integration with the project management process

Session End Time 4:30 PM EDT

Who Will Benefit

  • Any member of a cross functional project team that has the potential opportunity to lead that project.
  • Engineers
  • Marketing Associates
  • Product Managers
  • Program Managers
  • Contract Managers
  • Project Managers
  • Research & Development Associates, Managers, and Directors
  • Design Engineers
  • Manufacturing Managers

This virtual seminar crosses all industries and functions it is however particularly suited for the health sciences where much project-based work is accomplished.

·      Medical device manufacturers

·      Pharmaceutical and Biotech organisations

·      Cosmetic and foods manufacturers

·      All other industries

FDA Faculty Charles H. Paul

Know Your Faculty

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.

The firm works globally completing projects throughout the EU, UK, South America, and Asia.


RAPS - This course has been pre-approved by RAPS as eligible for up to 8 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria