COURSE DESCRIPTION

OVERVIEW

Successful technology transfer in the manufacturing of pharmaceutical products is a stressful and expensive process that is fraught with risk. Whether you are moving from early R&D to producing product for clinical trials, scaling up commercial manufacturing, changing your process, or moving to an outsourced model, careful planning and execution is needed. While firms have been doing this for as long as regulated pharmaceutical products have been made, there is little guidance and few have an optimal process.   The design of tech transfer is difficult enough, but the execution of that transfer is a complex process involving the interactions of many disciplines across an organization. Documents, data, institutional knowledge, and cross-functional cooperation are all critical. So the question remains…where to start?

This course will give you the tools to understand pharmaceutical technology transfer from the planning through implementation phase, plus offer clear, actionable steps you can take to ensure success. You will receive best practices and learn from first-hand anecdotal experience. As you progress through the interactive session, you will be encouraged to ask questions and engage in discussion. Additionally, you will receive job aids to assist you and your colleagues in your efforts to ensure pharmaceutical manufacturing technology transfer success.

LEARNING OBJECTIVES

During the session, you will learn:

• The definition of Technology Transfer and its many applications

• Planning for tech transfer the “right way,” using “Calculated Risk Reduction” and other tools to ensure your bases are covered
• Common pitfalls and best practices – what to do, and what not to do.

• Implementation strategy: When, What, and How
• Ways to ensure optimal planning and execution using actionable job-aids