Get the latest information on requirements for product and personnel protection, containment, and environmental safety. Understand the implication of personnel and materials flow on the layout, as well as the materials and methods of construction of equipment and facilities, particularly from the perspective of cleanliness, functionality, and maintainability. Take note of critical process equipment and utility system attributes (performance, functionality, construction, instrumentation) and the impact on personnel and product cleaning systems including CIP/SIP. Additionally, review fundamentals of good engineering practice. At the conclusion of this online course, participants will have knowledge of:
- Requirements for product protection and containment
- Requirements for personnel and environmental safety and protection
- The importance of personnel flow and materials flow and their implications for layout
- The materials and methods of construction of equipment and facilities, particularly from the perspective of cleanliness, functionality, and maintainability
- Critical process equipment and utility systems’ attributes (performance, functionality, construction, instrumentation) and their impact on personnel and product
- Cleaning systems including CIP/SIP
- The fundamentals of good engineering practice
- Years in industry: 0-4 to 5-14
- Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s).
Jeffery Odum is president of NCBioSource USA and ISPE North American Education Advisor. He has been involved in the biopharmaceutical industry for more than 20 years with expertise in engineering design, construction, and plant operations. Prior to founding NCBioSource, he was a successful market leader for an international engineering design firm specializing in biopharmaceutical manufacturing facility design and construction. His experience includes design and construction of many of the industry's major manufacturing projects, as well as consulting roles for a number of the global biotechnology industry leaders. Odum is a nationally recognized author, speaker, and Subject Matter Expert with industry insight in the areas of regulatory compliance, facilities and process design, and project management for biopharmaceutical companies. He has been a Member of ISPE for more than 15 years and has been a presenter and course leader for more than 50 professional training and education sessions within the industry. He is a past chairman of ISPE's North American Continuing Education Committee (NAEC) and the ISPE Training Committee. As North American Continuing Education Advisor, he works closely with the NAEC and the ISPE Staff in the development of the society's North American conferences and educational products. He is also a Member of ISPE's Technical Training Staff, where he has provided professional training in the United States, Europe, Asia, and Latin America. In 2002, he received the Society's prestigious Richard B. Purdy Award for Outstanding Achievement within the biopharmaceutical industry. Odum is the author of more than 30 published works on many critical issues, including process improvement and execution to meet regulatory guidelines issued by the FDA and other international regulatory bodies. He was also one of the lead chapter authors for ISPE's Biopharmaceutical Manufacturing Facilities Baseline® Guide. Odum graduated from Tennessee Technological University with a degree in mechanical engineering and received his Master's Degree in engineering from the University of Tennessee-Knoxville.