Goals and Objectives Discuss CDER s proposal for risk-based CMC reviews. Identify appropriate attributes and acceptance criteria for drug substance, drug product, and microbiology which can be used to establish a list of low risk drugs. Identify attributes and acceptance criteria important for establishing the GMP status of manufacturers making the low risk drugs. If you do not have Adobe Acrobat to view the file, please download it from the Adobe website. Format There will be four different breakout session topics.
Participants can select any three.