This online course provides a review of the concepts utilized in the development of sound designs for facilities that manufacture biopharmaceutical products. It also covers key concepts, processes and strategies required for facility design covered in the Biopharmaceutical Manufacturing Facilities baseline guide.
- Define the key concepts covered in the guide.
- Identify the key concepts, processes, and strategies required for facility design.
- Identify additional references within the Baseline Guide
- Individuals who want to improve their working knowledge of biotechnology manufacturing facility design concepts.
- Professionals who need a focused understanding of the issues a biotechnology manufacturing.
- company must address in order to develop a facility design that meets current regulatory requirements and corporate economic goals.
- Individuals who provide services and/or assistance to biotechnology manufacturing companies to design, construct, validate, and finance facilities.
Jeffery Odum offers more than 25 years management experience in the design, construction, and commissioning of the facilities in the process, biotechnology, pharmaceutical, and chemical industries. Throughout his career, he has been involved in managing conceptual design, detailed design, pre-construction, construction, start-up and validation support for projects ranging in sizes from $1 million to more than $2 billion. Mr. Odum conducts facility compliance and quality systems audits and has participated in the development and presentation of licensing packages to the US FDA. He has provided cGMP audit services and training to Fortune 500 global biopharmaceutical companies, focusing on FDA and EU compliance as part of inspection readiness for the FDA and other global regulators. Mr. Odum has over 50 articles on the subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.