ICH Quality Implementation Working Group (Q-IWG) Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10

Information from the workshops will be used by ICH Q-IWG to support the harmonised implementation of ICH Q8, Q9 and Q10. Workshop materials are suitable for internal training by industry and regulators.

International Conference on Harmonization (ICH), guidances on Pharmaceutical Development (Q8), Quality Risk Management (Q9), and Pharmaceutical Quality System (Q10).

• www.ICH.org
• Download the ICH Q-IWG Q&A

Download Presentations from the Washington Training Event

Presentation	Presenters
Case Study ( 551 KB)
Introduction ( 103 KB)	Jean-Louis Robert, Rapporteur of ICH Q-IWG Department of Quality Control of Medicine, Luxembourg
How ICH Guidelines are Working Together throughout the Product Lifecycle ( 253 KB)	Moheb Nasr, FDA, CDER, Q-IWG
Product Development ( 290 KB)	Jean Wyvratt, Merck & Co., Inc., Q-IWG
Regulatory Assessment ( 210 KB)	Elaine Morefield, CDER, FDA, Q-IWG
Implementation and PQS Considerations ( 449 KB)	Nigel Hamilton, Sanofi-Aventis, UK, Q-IWG
Inspections at a Manufacturing Site ( 194 KB)	Jacques Morénas, AFSSAPS, France, Q-IWG
Q-IWG Status and Update ( 219 KB)	George France, Pfizer, UK, Q-IWG

Key Messages & Discussions	Presenters
Design Space ( 163 KB)	Moheb Nasr, FDA, CDER, Q-IWG George France, Pfizer, UK, Q-IWG
Control Strategy ( 231 KB)	Bob Baum, Pfizer, USA Jean-Louis Robert, Dept. QC of Medicines, Luxembourg
Pharmaceutical Quality System ( 182 KB)	David Cockburn, EMA Swroop Sahota, Merck & Co., Inc.
Quality Risk Management ( 686 KB)	Stephan Rönninger, F. Hoffman-La Roche, Ltd., Switzerland Diana Amador-Toro, FDA, ORA

European and USA events are co-sponsored by ISPE and PDA on behalf of the International Conference on Harmonization (ICH).