Introduction to Pharmaceutical Manufacturing
Covers the fundamental elements associated with the development and manufacturing of pharmaceutical products. Training modules discuss pharmaceutical product categories; phases of pharmaceutical discovery; and development, approval, and varying manufacturing processes (chemical or biological).
Understanding the Science of the Biopharmaceutical Industry
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
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).
Pharmaceutical Facility Operations
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.
Safety in the Biopharmaceutical Industry
This course covers a wide range of safety, health and environmental 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.