Elemental Impurities

Wednesday, May 4, 2016 - 11:00am to 1:00pm

This webinar covers the current and emerging global regulations and overview of implementation considerations for Elemental Impurities.

Presentation Objectives

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(s)

Dave R. Schoneker

Dave headshot
Director of Global Regulatory Affairs
Colorcon

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.

Cancellation Policy

Note: No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you are unable to attend the webinar, a recording of the webinar will be provided to all registered persons.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org