Documenting the Drug Development Process — ICH Q8(R2)

FDA issued the International Conference on Harmonization (ICH) guidance Q8(R2) Pharmaceutical Development. This guidance addresses documenting the drug development process via the Common Technical Document (CTD). Topics in this course include: CTD, Pharmaceutical Development, Drug Components, Drug Product, Manufacturing Process, Container Closure System, and Microbial Attributes. After completing this course, learners will be able to recognize the FDA guidance on pharmaceutical development and be able to identify how it can be used to design and manufacture safe and effective pharmaceutical or biological products that are of consistent quality.

After this course learners will be able to recognize the guidance from fda covering the documentation of pharmaceutical drug development. identify how the guidance can be used to consistently deliver pharmaceutical and biological products of the required quality.