Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
Join us as we take a deep dive into critical areas of pharmaceutical manufacturing at the ISPE Bethesda Training Facility located at 6110 Executive Blvd, Suite 600, North Bethesda, MD 20852.
This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
Norman Goldschmidt is President and Sr. Principal at Genesis Engineers. He has over 30 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry. Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.
This classroom course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.
Jefferey Jones, Executive Director of Quality at Humacyte, Inc., has over 20 years of experience with development-stage and commercial biopharmaceutical process technology transfer. In his current role, Jefferey oversees Quality aspects of facility, process, and instrumentation design and scale up for a novel biologic process manufacturing bioengineered blood vessels.