Product Development and Process Validation

Catalog description

Studies the compliance standards associated with commercializing new biopharmaceutical and medical device products. Focuses on U.S. regulations, although discusses compliance with standards in other major geographical areas as well, including those in Canada and the European Union. Offers practical instruction in the product design control process, setup of small-batch manufacturing processes, scale-up to large-scale manufacturing processes, as well as the regulatory requirements for manufacturing process validation. Includes a detailed analysis of process flow, incoming raw material and work-in-progress testing, stability testing, sterility testing, and handling requirements. Other topics include creation of design history files, establishment of master validation plans, and compliance with ongoing facility and manufacturing equipment standards.