Proven techniques and creative tools presented for design,
development, and delivery of biopharmaceutical manufacturing facilities.
Includes skills and knowledge in bioprocessing requirements, equipment and facility requirements, project management as well as regulatory guidelines and big-picture drug development. Also corporate capital management processes to functionally meet corporate requirements from pre-clinical to commercial scale of operations, qualifications to pass regulatory inspections, achieving faster time-to-market, but not breaking the corporate treasury bank. Course also explores trends in new equipment technology such as disposables or single-use product, new design concepts in aseptic manufacturing, barrier and isolation
technologies, new FDA thinking in risk-based compliance approach, process
analytical technology, capital project planning and management.