ICH Quality Management Training Program Presentations

Archive of Q8/Q9/Q10 training program for API (small and large molecules) and drug (medicinal) products; industry involved in development, manufacturing, quality, regulatory affairs; and regulators responsible for dossier assessments and GMP inspections. This training program provides a comprehensive training on the integrated implementation of Q8, Q9 and Q10 in pharmaceutical development and manufacturing, regulatory assessment, scale up, implementation into commercial manufacturing operations and GMP-inspection. A specific case study was used demonstrating opportunities when using the combination of Q8, Q9, Q10. The workshop material is intended to be used for internal training purposes for industry and regulators.