Course Catalog - National Center for Therapeutic Manufacturing ...

courses13Documentation in cGMP environmentsCurriculum discusses the variety of documentation practices andprotocols in current Good Manufacturing Practices (cGMP) environments.Topics include principles of data and information entry, basicsof technical writing, and process documentation, including laboratorynotebooks, logbooks, and batch production records (BPRs). Controlof these documents, deviation reports, production and process controls,laboratory controls, and calibration programs and documentationare also included. An overview of the entire documentation pathwayfrom R&D to commercialization of product, including corporate, R&D,manufacturing and quality documents is provided.Pharmaceutical Facility OperationsParticipants receive a comprehensive overview of the variety ofbiologics, drug, and device manufacturing facilities, including design/layout, utilities, and equipment. Students learn about principles ofaseptic techniques, sterilization, and environmental monitoring, aswell as hazards, risk mitigation, and their relation to worker andenvironmental safety. The importance of equipment maintenanceand calibration are also taught along with data analysis principles andreport generation as they relate to pharmaceutical facility operations.Safety in the Pharmaceutical IndustryThis course covers a wide range of safety, health and environmental(SHE) issues specifically related to the pharmaceutical manufacturingindustry. Topics include BSL 1-3, risk assessment/analysis, toxicology,and industrial hygiene. Students learn about process and productsafety and investigate case histories, historically significant accidents,and lessons learned.Corrective & Preventative Actions (CAPA)Attendees are introduced to failure recognition, deviations, root causeanalysis, corrective actions, and other elements of risk mitigation. Thecourse explains the regulatory environment surrounding CAPA, how aCorrective and Preventative Actions (CAPA) system works, the basicsof an investigation, and how an investigation is performed.