Jeffrey Hofer

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Eli Lilly & Co Mfg & Quality Learning Ctr
Sr Research Advisor, Global Statistical Sciences
Mr. Hofer is a Senior Research Advisor in the Global Statistical Sciences team at Eli Lilly. He received a B.S. in Applied Statistics from the Rochester Institute of Technology in 1988, and a M.S. in Statistics from Iowa State University in 1990. Mr. Hofer has worked as a statistician at Eli Lilly and Company since 1990. During his career, Mr. Hofer has provided statistical support to new product development as well as manufacturing. Throughout his career, Mr. Hofer has collaborated with scientists designing studies and analyzing data in the development of optimal formulations and methods and summarizing information to be provided in regulatory submissions. Mr. Hofer’s current area of primary support is related to drug product continuous manufacturing. Externally, Mr. Hofer was a member of the PhRMA CMC Statistics Expert Team from 1994-2009 and acted as Chair of the group from November 1997 thru May 2005 and is currently a member of the AAPS CMC Statistics Focus Group and the USP Expert Committee on Content Uniformity for Large Sample Sizes.

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Sampling Considerations in Continuous Manufacturing

Sampling is the selection of a representative portion of the population to make inferences about the entire population. In pharmaceutical manufacturing, samples are drawn from different stages of the process for both controlling process parameters and assessing drug product quality. In the case of a traditional batch process, a fixed amount of material is processed and the batch quality is...