Dr. Elaine Morefield is currently the deputy office director for review and administration, in the Office of New Drug Quality Assessment at the US FDA. She was previously the premarketing approval division II director in ONDQA. She has over 20 years experience in the pharmaceutical industry.
Betsy has held positions of increasing responsibility in quality and API manufacturing in J&J. She is a member of the Expert Working Group for ICH Q11 Development and Manufacture of Drug Substances. She was also a member of the EWG for ICH Q7.
Dr. Elaine Morefield is currently the deputy office director for review and administration, in the Office of New Drug Quality Assessment at the US FDA. She was previously the premarketing approval division II director in ONDQA. She has over 20 years experience in the pharmaceutical industry.
John Kauffman is a research chemist at the FDA Division of Pharmaceutical Analysis. His team develops spectrometric methods for rapid drug analysis and applies ICPMS to analysis of metals in drugs. He is the FDA topic lead on ICH Q3D, and FDA Liaison to the USP Advisory Panel on metal impurities.
Description
This forum will discuss ICH topics related to pharmaceutical quality, including the new guideline for drug substances (Q11) and the Q8, Q9, and Q10 points to consider document.
Learning Objectives: Describe the scope and content of recent ICH documents related to quality Discuss Q11 for drug substances, Q3D for metal impurities and the quality implementation groups points to consider documents.