Course Description:
This course integrates ICH Guidance and FDA policy for impurities, relevant USP General Chapters about impurities, and USP’s approach to impurities in monographs. It also provides insights to USP‒NF General Chapters <476> and <1086> and include case studies for impurities in the development and revision of USP monographs.
Date: [course_completion_date]
Couse Duration (hh:mm:ss): 05:09:07
Instructor:
Ravi Ravichandran Ph.D.