ICH Q11

Online Learning Courses

ICH Q11: Development and Manufacture of Drug Substances Status, Challenges, and Expectations

ICH Q11 has been an industry hot topic for years, and now the guideline has reached the consultation phase. In this recording, captured at ISPE's 2011 Washington Conference, ICH Expert Working Panel member Betsy...
Development & Manufacture of Drug Substances, ICH Q11
Guidance Docs

GMP Regulation Handbook: Development & Manufacture of Drug Substances, ICH Q11

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics...