Analyze batch records, contamination controls (cleaning, segregation, HVAC, etc.) and changeover. Gather details on critical factors that impact quality and control, as well as methods and tools for data manipulation and analysis. Identify critical quality attributes and process controls. At the conclusion of this online course on Production Control, participants will have knowledge of:
Attendance suggested for:
Mark Witcher, Ph.D. is a consultant to the biotechnology and pharmaceutical industries on operational issues related to product development; strategic business development; clinical and commercial manufacturing planning; process development; technology transfer; organizational development; and facility design and construction. Previously, Witcher was Senior Vice President of Manufacturing Operations for Covance Biotechnology Services (formerly Corning Bio, Inc). At Covance, he was responsible for the design, construction, start-up, and operation of the company’s $50mm contract manufacturing facility. Prior to joining Covance, he was Vice President of Manufacturing for Amgen, Inc. Witcher was with Amgen for nine years and held positions as a Senior Process Engineer, Engineering Manager, Plant Manager, and Director. He received his Ph.D. in chemical engineering from the University of Massachusetts.