Project Management in the Life Sciences - Project Management Fundamentals for Non-Project Managers

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.

WHO SHOULD ATTEND:

• Directors, Vice Presidents and Management Teams
• Engineering Departments
• Product Managers
• Program Managers
• Contract Managers
• Project Managers
• Research & Development Departments
• Design Engineers
• Manufacturing Departments
• Marketing Associates
• Medical Device Manufacturers
• Professionals in Pharmaceutical and Biotech Organizations
• Cosmetic and foods Manufacturers
• Members of American Society for Quality
• Members of American Pharmaceutical Manufacturers of America
• Members of Generic Drug Manufacturers Association
• Members of National Pharmaceutical Association
• Members of International Society for Pharmaceutical Engineering
• Members of Medical Device Manufacturers Association
• Members of European Medical Device Technology
• Members of Gulf Coast Medical Device Manufacturers
• Anyone that participates in or has the potential to manage team-based cross-functional projects

DAY 1 (11 AM to 3 PM)

• 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

Session 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
• 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

Session 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 2 (11 AM to 3 PM)

• R & D process integration with standard PM processes
• The project management success factors for project managers in the pharmaceutical and biotechnology industries

Session 5: 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

Charles Paul is the President of C. H. Paul Consulting, Inc. His firm is renowned for its expertise in regulatory compliance, training solutions, and technical documentation consultancy. With over three decades of experience as a regulatory consultant, Chuck has authored numerous insightful white papers on a wide array of regulatory topics. His firm collaborates with clients globally, crafting innovative solutions for intricate regulatory challenges, Lean methodologies, comprehensive training programs, and meticulous documentation strategies. Since over a decade now, he has been a widely established presenter and trainer at webinars and seminars on a numerous quality, regulatory and project management topics.