Fred Ohsiek is the Sr Cleaning Validation Specialist at Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from the University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies, Bayer (biotech division), and Novo Nordisk. Fred’s cleaning validation experience includes developing/optimizing and validating cleaning procedures and creating/improving monitoring programs. His scope of work has included small synthetic organic molecules and biologics, OTC, and nutritional products; oral dose (solid and liquid) and parenteral; API and finish product manufacturing; greenfield and brownfield; and remediation, legacy process justification, and increasing manufacturing capability. He has authored documents and executed in every aspect of the cleaning validation process. To stay current on new CV trends and practices, Fred also attends and presents at numerous US and international validation and cleaning validation conferences annually.