Project Management for Life Sciences

The development of pharmaceutical and medical device products involves steps that do not occur in other industries. This course shows you how to apply fundamental, widely-used project management principles to these industries taking into account regulatory requirements, clinical trials, and other aspects of the product development lifecycle that are unique to these types of products. You'll review fundamental project management concepts with special attention paid to biological science industries, examine how project scope, planning, and risk are addressed in the development of FDA-regulated products, and explore why it is important for project managers in these industries to have some technical knowledge in order to be effective. This course prepares you for further study of more advanced topics in this certificate program.

Become an effective and productive leader in your pharmaceutical company. You'll learn how to apply facilitative leadership techniques in the management of pharmaceutical product projects. The workplace environment and the nature of the pharmaceutical product are unique to this industry and warrant specialized treatment. Topics include leadership vs. management, approaching your leadership challenges from a global perspective, negotiating and influencing, effective communications, and building high-performance teams.

Today, many pharmaceutical, biotechnology and medical technology companies have workers dispersed around the globe. Project teams may have members in geographically diverse locations which creates project management challenges. This course teaches you how to lead a culturally and geographically diverse team taking into consideration different cultural norms, working styles, and educational backgrounds. You'll also explore tools for managing a virtual team.

Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America.

This course presents a detailed overview of the regulatory requirements for the development and manufacture of pharmaceutical products. Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization; product characterization and pre-clinical evaluation; pharmaceutical industry requirements; clinical trial requirements, good manufacturing practices (GMPs); good laboratory practices (GLPs); Regulatory compliance inspections, labeling, and advertising of medical products; and preparing Food and Drug Administration (FDA) submissions.

Project managers and functional managers in today's highly competitive biotechnology industry face tough challenges. People in these positions require key managerial competencies, business knowledge, technical competency, and strategic insight in order to perform both individually and as members of a team contributing to the success of their organization. This course for life science managers focuses on the special aspects of project management in the research and development phase and the discovery phase of product development. The course is highly interactive and encourages students to participate actively in the learning process. The goal is for students to take the tools and skills learned in the course into their workplaces where they can quickly realize improved project performance.