Your Course Leader

Dr Nadine Ritter is a CMC technical, regulatory and quality consultant and instructor to the biopharmaceutical industry, where she provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.