ICH Q3D Guideline for Elemental Impurities will be effective June 2016. Learn from the excipient experts how this will impact your company as a maker or user.
Current and emerging global regulations
Status update on ICH Q3D and Implementation Working Group (IWG)
Pharmacopeia updates/implementation timelines
The need for a globally harmonized implementation plan
Regions/Countries beyond U.S., EU, and JP
Overview of implementation considerations
Q3D Implementation Working Group Training Modules
Risk assessment considerations and concerns
Assessment of Ingredients - Potential for Variability and Excursions
Testing - Technical and Analytical Challenges
Industry programs to assist implementation
Presenter
David Schoneker: Director of Global Regulatory Affairs at Colorcon. Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009. He is now serving as the Vice Chair Science and Regulatory Policy on IPEC-Americas Executive Committee. He is also Vice-Chair of the IPEC-Americas QbD/Product Development Committee and Composition Committee. Mr. Schoneker also serves as the Global Expansion Coordinator for the IPEC Federation and has been involved in the start-up of various other IPEC groups such as IPEC China and IPEC India.
