Builds upon previous knowledge of quality assurance and regulatory affairs to study the harmonized quality system approaches of the International Committee on Harmonisation (ICH). Pays special attention to the topics of quality risk management, qualification, and validation. Covers topics in the American Society for Quality’s Body of Knowledge for a Certified Pharmaceutical Good Manufacturing Practice Professional examination. Field trips may be required. Prerequisites: Introductory Statistics (MATH M15 or MATH M15H) or equivalent or placement as determined by the college's multiple measures assessment process, BIOL M02A or BIOL M02AH, BIOT M10 or BIOL M13, BIOT M02C or BIOL M12C, BIOT M02D or BIOL M12D, and BIOT M02E or BIOL M12E. Transfer credit: CSU.

Builds upon the scientific knowledge underlying chemical engineering principles to design, develop, and optimize key parameters in a biomanufacturing process. Includes the optimization of media composition, fermenter and bioreactor design, the design of downstream processes, instrumentation, engineering systems, and process control systems in process development to maximize the yield and integrity of a protein pharmaceutical. Field trips may be required. Prerequisites: Introductory Statistics (MATH M15 or MATH M15H) or equivalent or placement as determined by the college's multiple measures assessment process, BIOL M02A or BIOL M02AH, BIOT M10 or BIOL M13, BIOT M02C or BIOL M12C, and BIOT M02D or BIOL M12D. Transfer credit: CSU.