Drug Quality Fundamentals: Quality Control of Small Molecule Drugs and Biologics


This introductory course provides an overview of key drug quality concepts and standards for the pharmaceutical and biotechnology industries. Interactive lectures explore quality system and control process best practices in clinical development, drug manufacturing and for commercial products. You'll learn the roles and responsibilities of quality assurance (QA) and quality control (QC) in ensuring the safety, efficacy and quality of drug products. You'll contrast specific quality attributes of large-molecule recombinant biological products with those of small molecule drugs. The course surveys the analytical chemistry methodologies used to assess and control physicochemical properties.

Prerequisites :


Offering code Offering title
BTEC.X401 Drug Development Process
REGL.X400 Good Manufacturing Practices
REGL.X403 Regulation of Drugs and Biologics