Fred Ohsiek, Cleaning Validation Expert

Fred Ohsiek has performed cleaning validation for 22 years for small and large molecule API and finished-product manufacturing for 7 major pharmaceutical companies. This experience gave Fred a good perspective on industry best practices and practical solutions.

His experience covers every stage of the CV life cycle – from cleaning optimization to cleaning validation to continued process verification (CPV).

His experience includes legacy and startup facilities. Therefore, he is experienced in defending, remediating, or optimizing legacy facilities or building a CV program from the ground up.

He was one of the authors on the ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controlsand the CV acceptance criteria chapter lead. This was a three-year project which included weekly meetings with industry SMEs to discuss very topic within the cleaning validation sphere.

Fred also has experience with cleaning challenges and issues. While working for Ecolab Life Sciences, Fred conducted site surveys; solved cleaning problems; assisted in optimizing cleaning processes; and conducted onsite CV training for major pharmaceutical and biotech corporations.