Jeffery Odum, CPIP is the Director of Operations for IPS, located in the Morrisville (RTP) North Carolina office. As a recognized Subject Matter Expert, he has been involved in the biopharmaceutical industry for more than 20 years. He is an internationally recognized author, speaker, instructor and industry consultant who provides insight in the areas of regulatory compliance, facilities and process design, and project management for many global biopharmaceutical companies. Jeff’s experience in the biopharmaceutical industry has included many of the industry’s major manufacturing projects, as well as consulting roles for a number of the global biotechnology and pharmaceutical industry leaders. These projects represent a total capital investment of well over $2 billion dollars and produce many of the key biopharmaceutical therapeutics and vaccines currently in the marketplace. As a recognized SME, he provides facility and quality system audit services for companies preparing for USFDA and EMA inspections. The audits focus on GMP compliance and include manufacturing, quality, facility, and documentation systems. He is an internationally sought-after speaker and instructor, having taught courses in the United States, Europe, Australia, Japan and India. He is an Instructor in the Graduate School at North Carolina State’s BTEC Biomanufacturing program and also teaches professional and workforce development courses for the North Carolina Community College’s BioNetwork program. As a 20 year member of ISPE, he has also led numerous global training and professional education programs. Jeff is the author of more than 50 published works on many critical issues, including process improvement and execution to meet regulatory guidelines issued by the FDA and other international regulatory bodies. These works include three books that are recognized industry reference guides, including Sterile Product Facility Design and Project Management (CRC Press). He was also one of the lead chapter authors for the ISPE Baseline Guide: Biopharmaceutical Manufacturing Facilities, and is on the development team for the upcoming Biopharmaceutical Process Development and Manufacturing Guide and has recently completed, along with the development Team, the Good Practice Guide: Project Management.