This online course will explore the history of the biotechnology industry and will cover the fundamental concepts of biotechnology science. Participants will also learn basic terminology and how it is applied in the industry. The course will identify basic process science and unit operations for the manufacture of products and will describe the regulatory foundation that makes biological products different from traditional pharmaceutical products. This fundamental course is ideal for professionals that are new to the biotechnology industry, professionals entering new work assignments encompassing biotechnology operations, or individuals with previous pharmaceutical industry experience that want to learn the basics of biotechnology. This is a course that is ideal for individuals involved in human resources, economic development, and business and strategic planning efforts. Professionals in quality control, quality assurance, and technical management support will also find it beneficial.
There will be discussions to evaluate emerging technologies and how they will impact the industry. The course will also classify validation issues surrounding compliance with GMP and define basic requirements for facilities that manufacture biological products.
Course Modules/Learning Objectives
- Module 1: Basic Biotech Principles
- Recognize basic biotechnology principles
- Review the science of biotechnology
- Understand the basic elements of biology important to biotechnology
- Discuss the basic scientific principles of the bioprocess
- Module 2: Biotech and Bioprocess Design
- Review Bioprocess basics
- Review biotechnology GMPs
- Review regulatory guidance
- Describe key manufacturing facility design attributes
- Module 3: Biotech Facility Design
- Define biotech facility attributes
- Define the Biotech Project
- Professionals who are new to the biotechnology industry.
- Professionals entering new work assignments encompassing biotechnology operations.
- Individuals with previous pharmaceutical industry experience wanting to learn the basics of biotechnology.
- Individuals involved in economic development, human resources, and business and strategic planning efforts which involve current or potential biological production services clients.
- Quality control, quality assurance, technical support, and management personnel.
Jeffrey Odum offers more than 25 years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, pharmaceutical, and chemical industries. Throughout his career, he has been involved in managing conceptual design, detailed design, preconstruction, construction, start-up and validation support for projects ranging in size 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 for Fortune 500 global biopharmaceutical companies, focusing on FDA and EU compliance as part of inspection readiness and for FDA and other global regulators. A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over 50 articles on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to facility design, bioprocess, project management and GMP compliance.