Skip to main content
Connecting Pharmaceutical Knowledge
Menu
Join/Renew
Login
Store
Search
Main navigation
Conferences & Training
Conferences
Upcoming
On Demand
Training
On Demand
Online Live
Custom Onsite
Webinars
Global Event Calendar
Exhibits & Sponsorships
Membership & Communities
Membership
Volunteer Opportunities
Communities of Practice
Affiliates and Chapters
Women in Pharma
Emerging Leader
Students
Career Opportunities in Pharma
Partner Showcase
Virtual Exhibits
Get Involved
Publications
Guidance Documents
Guidance Document Portal
Pharmaceutical Engineering Magazine
Glossary
iSpeak Blog
Concept & Discussion Papers
Advertising
Programs
Facility of the Year Awards
Foundation
Regulatory & Initiatives
Pharma 4.0
About ISPE
About ISPE
Leadership
Videos
News
Staff
Careers at ISPE
You are here
Home
ICH Q11
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...
Guidance Docs
GMP Regulation Handbook: Development & Manufacture of Drug Substances, ICH Q11
1 November 2012
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics...