Steven A. WeitzelVP- Technical Operations CANI, Inc.
Steven Weitzel is a highly experienced risk-based process validation SME with 36 years of manufacturing and engineering experience and 25 years technical experience in FDA regulated industry in engineering, manufacturing, process validation and technical marketing.
Weitzel has experience in development and validation of cleaning and microbial contamination control for FDA regulated drugs, biologics, dietary supplements and medical device manufacturing.
He has conducted technical training or consulted for the world's leading pharmaceutical, biotech, cosmetic and medical device companies including Bristol-Myers Squib, Novartis, Pfizer, JnJ, Sanofi, Merck, Teva, Amgen, Genentech, Chanel, Revlon, L’Oreal, Medtronic, DePuy, Henkel/Dial.
Steve has worked in primarily in North America and Europe, but has also worked in India, Saudi Arabia, Iran, UAE, Egypt and Southeast Asia and is familiar with all types of firm size and corporate structure.
He began in Process Development at Dow Chemical in Texas, moved to St. Louis and directed manufacturing of diagnostics and APIs, then went to Mallinckrodt Medical where he was responsible for the facility, critical systems, validation and maintenance of a complex nuclear medicine manufacturing plant.
He moved to Calgon-Vestal division of Merck running manufacturing technical services. While at Calgon-Vestal (now Steris) he transferred from manufacturing/engineering to technical marketing and was responsible for introducing CIP 100 and other cleaning agents and validation support programs to FDA regulated markets. He also was responsible for their disinfectants and Spor-Klenz products for aseptic manufacturing. Since leaving he has been involved in hundreds of facilities, projects and applications related to process validation and contamination control.
Current responsibilities at CANI include external technical support and technical marketing, as well as managing all internal technical operations -manufacturing, validation and quality systems.
Weitzel has published or made over 70 technical presentations on the topics of process validation, risk-assessment and change control; validation master plans; risk-based contamination control; aseptic manufacturing; microbial control and environmental monitoring; critical cleaning and cleaning validation.
He has been involved in several professional organizations including PDA and ISPE, serving on technical, training and policy committees.
Dr Upendra Bahuguna
Dr Mithilesh Trivedi