Fred Ohsiek

Fred Ohsiek

Associate Director of Cleaning Validation

Eliquent Life Sciences

Fred Ohsiek who earned his BS in Chemistry from University of South Florida, resides in the NC RDU area. He has 25 plus years of validation experience as an FTE and Consultant, while specializing in cleaning validation.
He has been fortunate to work for 7 major pharmaceuticals (Catalent, AstraZeneca, Boehringer Ingelheim, Teva, Astellas, Bayer, and Novo Nordisk) where he was considered the cleaning validation SME in most of his roles. Working with various routes of administration (OSD, parenteral, topical, and softgels) in green and brown field small and large molecule manufacturing projects has provided Fred with a very broad range of experience.
Fred also obtained “cleaning chemistry” experience while working as a Sr Global Technical Manager at Ecolab (Life Science division).
As Associate Director of Cleaning Validation at Eliquent Life Sciences, he and his team support industry by authoring tailored justifications, reducing the validation footprint via risk assessments, creating startup CV programs, remediating legacy processes, and increasing manufacturing capability.
He was one of the authors of the ISPE Cleaning Validation Lifecycle – Application, Methods, and Controls guidance, and he regularly presents at conferences nationally and globally.

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