Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

Project Management for Non-Project Managers Course Description

Faculty Charles H. Paul President at C. H. Paul Consulting LLC Tobyhanna, Pennsylvania, United States ( 30 + yrs exp)

What do you do? Here is a common scenario. You are three years out of college in your first engineering job. You are sitting in a meeting about the introduction of a new packaging line in your pharmaceutical plant. You are half listening to the presentation while thinking about some of the other work you need to complete on different matters. The installation will take a year to execute and will require the coordination with several functions inside and outside of the company. 

Suddenly the Director of Engineering turns to you and says "Allison, this would be a great first opportunity for you to manage a very interesting project. Let's meet tomorrow and discuss your initial plans for getting started."  

This is an all too common occurrence in today's business environment. 

Today more than ever before the job titles that we hold are not entirely reflective of the work that we do. Global teams and collaboration often place those in positions of team leadership that have the least foundation to manage all facets of complex projects. Project management requires specific knowledge of the key project facets that must be carefully managed. The interactions across divergent corporate functions, culture, language, and time zones all pose unique challenges to the new project manager. Layer on top of the basic project management requirements for any project the requirements of a pharmaceutical/biotechnology or medical device development project and the entire project management process becomes a daunting task for even those with experience.

 Unfortunately, project management is not a subject given much attention in college and university these days. The answer? Get some training - some basic understandable project management training that will provide you with a solid foundation for managing that first project or to simply sharpen existing project management skills.  

It is not just important to learn about project management – project management has its own body of knowledge – its own set of standards that all project managers follow called the Project Management Body of Knowledge. Any valuable training must also teach/present the content comprising this Body of Knowledge.

Driving a product to the market safely, quickly, and cheaply is the best way for a pharmaceutical company to be successful. Those companies however, encounter enormous challenges during the long product-development process. The unique regulatory requirements of pharmaceutical/biotechnology and medical devices as well as the project development processes associated to each industry must also be addressed to meet the needs to facilitate approval.  

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