DAY 1 (11 AM to 3 PM) Session 1: Introduction to Project Management – An Overview
| Session 3:Risk, the project team, project management and control
Session 4: The unique challenges and requirements of pharmaceutical/biotechnology project management
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ABOUT THE COURSE: 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:
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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 YOU SHOULD ATTEND:
It is not possible to present a complete treatment of project management in the span of 2 days. 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 two 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.
COURSE DIRECTOR: CHARLES H. PAUL
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. |