Risk Assessment And Testing Requirements For Elemental Impurities In The Pharmaceutical Industry




Register Now
Date: December 12, 2017
Time: 11 am EST | 8 am PST | 4 pm GMT | 5 pm CET

Overview

January 1, 2018, is fast approaching. Are you ready for the new U.S. Pharmacopeia (USP) requirements for instrument-based heavy metals testing covered by USP Chapters <232> and <233> and ICH Q3D?

Selecting the best risk assessment and analytical testing strategy is key to successful compliance with the new regulations. Join this webcast to gain an understanding of the guidelines, testing requirements, and analytical approaches for complying with the USP. Discussion will include steps to perform risk assessments, and testing requirements for oral, parenteral, and inhaled products. A Q&A session will allow a deeper dive into specific needs. 

Speakers

Scott Afton, PhD
Manager, CMC Structural Chemistry
Catalent

Scott Afton, manager of CMC Structural Chemistry for Catalent Pharma Solutions, has 13 years of experience in elemental impurities testing and research. At Catalent, he leads the Structural Chemistry organization that provides analytical support for non-cGMP and cGMP projects ranging from small and large organic molecules to elemental impurities. Sophisticated analytical techniques include high resolution mass spectrometry and multi-dimensional nuclear magnetic resonance spectroscopy. In addition, the Structural Chemistry organization routinely provides consultation for regulatory filing submissions. Dr. Afton’s primary responsibilities are summarized by driving development in employee engagement, effectiveness, and efficiency. He received a doctorate from the University of Cincinnati in Ohio.

Register Now
Date: December 12, 2017
Time: 11 am EST | 8 am PST | 4 pm GMT | 5 pm CET