BIOT M307

Advanced Topics in Quality Assurance and Regulatory Affairs

  • 4 units
  • Prerequisites

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. 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

Prerequisites

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.