See the Japanese version on the JPMA website

Basic Training
Introduction to ICH and the new Quality Paradigm
ICH Q9: Quality Risk Management
How ICH Q8, Q9, Q10 Guidelines are working together throughout the product life cycle
Enhanced Training Elements: Key Messages
Design Space
Control Strategy
Pharmaceutical Quality System
Quality Risk Management
Enhanced Training Element: Case Study
Product Development
Regulatory Assessment
Manufacturing Implementation and PQS Considerations
Inspection
Questions & Answers Document
Report on ICH Q-IWG Activities

The training event was recorded in Washington D.C. in October 2010

For creating paper copies of a manual with all slides see the Acrobat (pdf) version:








Disclaimer: The information within the presentations is based on the ICH Q-IWG members’ expertise and experience, and represents the views of the ICH Q-IWG members for the purposes of a training workshop.

The training material has been developed by members of the ICH Quality Implementation Working Group (Q-IWG):

Jean-Louis Robert (Rapporteur)
• Stephan Rönninger
• Diana Amador-Toro
• Urs Kopp
• Robert G. Baum
• Yoshihiro Matsuda
• David Cockburn
• Motoaki Mitsuki
• Georges France
• Elaine Morefield
• Richard L. Friedman
• Jacques Morénas
• Nigel Hamilton
• Masatoshi Morisue
• Hirotada Nagai
• Markus-Peter Müller
• Yukio Hiyama
• Tamiji Nakanishi
• Fusashi Ishikawa
• Moheb Nasr
• Takao Kiyohara
• Kazuhiro Okochi
• Anthony Ridgway
• Rachael Roehrig
• A J van Zyl
• Swroop Sahota
• Hideki Sasaki
• Tetsuhito Takarada
• Shigeki Tamura
• Krishnan Tirunellai
• Mats Welin
• Jean M. Wyvratt
• Akira Kusai
• Nicholas Cappuccino