Drug Substance and Drug Product Specifications.

Catalog description

This comprehensive course focuses on understanding the setting of specifications for the development of drug substances and drug products including regulatory guidance, statistical considerations, the creation of reasonable and meaningful specifications and the system processes to manage specification lifecycles in a compliant manner. Participants will gain an understanding of the importance of USP compendial and requirements as they pertain to the setting of specifications and regulations. ICH Q8, Q9, Q10 and the role of QbD in setting specifications as a part of an effective control system also will be addressed. Case studies and examples will be utilized during class to understand basic principles for setting specifications including traditional and statistical approaches. This is a hybrid course (>50% online) with distance-learning lectures and Canvas assignments. Prerequisites: Graduate student standing in the PCSP program or permission by instructor.