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Program Overview
Through NCTM, current pharmaceutical industry professionals can learn new skills to continue to meet the demands of this rapidly-changing field. Each of NCTM’s continuing education courses is developed and delivered by industry-experienced instructors and academic experts. Our curriculum incorporates principles of engineering and science in a variety of focus areas, including bioprocess equipment operations; process development, optimization, and scale-up; monitoring, analysis and testing; GLP, GMP, and much more.
Courses
Introduction to Pharmaceutical Manufacturing
Understanding the Science of the Biopharmaceutical Industry
This asynchronous online course provides a pragmatic study in the scientific principles of microbiology, immunology, and basic biochemistry that create the foundation for developing and manufacturing biopharmaceutical products. Curriculum covers biological macromolecules, an intensive study of infectious and non-infectious diseases, the immune system’s structure and function, pathogenesis, and categories, uses, and development process of biotherapeutics and vaccines.
cGMP Procedures and Documentation
This asynchronous online course explains the expectations of and reasoning behind proper documentation protocols mandated in current Good Manufacturing Practice (cGMP) environments, like pharmaceutical production facilities. Topics include principles of data and information entry, technical writing, recording guidelines, document control, and process documentation, including laboratory notebooks, logbooks, standard operating procedures (SOPs), and batch production records (BPRs). Participants will understand the entire documentation pathway from R&D to commercialization of product, including corporate, R&D, manufacturing and qualification/validation.
Pharmaceutical Facility Operations
This asynchronous online course provides an overview of pharmaceutical manufacturing facilities, including design/layout, utilities, and equipment. Participants will study clean room design, classification, and structure, and understand the many processes that are implemented to ensure a sterile environment, including practicing aseptic technique, gowning, environmental monitoring, and sanitization. Management of chemical and biological waste, sterilization techniques, and equipment maintenance and calibration are also discussed alongside the importance of validation in a pharmaceutical facility.
Safety in the Biopharmaceutical Industry
This asynchronous online course covers a wide range of safety, health and environmental (SHE) issues specifically related to the pharmaceutical industry, including environmental safety, process and product safety, biosafety levels, industrial hygiene, and physical and chemical properties. Participants will receive an overview of product development stages and vaccine production, and will learn about toxicity, toxicology, drug safety and evaluation, pharmacokinetics and toxicokinetics, as well as risk assessment and analysis. Case studies, historically significant accidents, and lessons learned are incorporated throughout to provide real-life relevancy.
Therapeutics Manufacturing: Past, Present and Future
This asynchronous online course provides a complete review of therapeutic products manufacturing, including small molecule (chemical) drugs and large molecule biologics.