Chemical and Biochemical Engineering - BI*
Provides a comprehensive coverage of all steps involved with the regulatory approval process for a biotechnology-derived product. Documentation preparation for IND, NDA, BLA. Pre-clinical safety data, clinical studies, facilities inspection and scientific and regulatory principles.
In-depth coverage of the development and implementation of good manufacturing practices (GMPs) in the biotech industry. Topics include building and facilities, equipment design, utilities, in-process controls, records and adequate process validation.
In-depth coverage of the key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products: quality concepts, product release testing and specifications, in-process testing, product characterization, qualityassurance documentation and audits and vendor certification.
Presents an in-depth discussion of the engineering design of a biotech facility under GMP compliance. Topics covered include bulk plant design, process equipment design, utilities, instrumentation, controls and computerization, facility and software validation.
*A student who completes the chemical/biochemical regulatory engineering concentration will earn the graduate certificate in that area. The individual departments offering these courses may be consulted for further information.