This webinar covers the current and emerging global regulations and overview of implementation considerations for Elemental Impurities.
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
David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments.
He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. He has been at Colorcon since 1977. Mr. Schoneker was the Chairman of IPEC Americas during the period 2007-2009. He is now serving as the Vice Chair of Science and Regulatory Policy. He is also a member of the Executive Committee of IPEC-Americas, and on the Board of Directors of the IPEC Foundation.
Dave 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.