Managing Emerging Quality Threats and Challenges: HFAs, Extractables/Leachables, FD&C Red No. 3, and Petroleum-Based Food Dyes
Tuesday, October 28, 2025
1:30 p.m. - 2:45 p.m.
Many ingredients, components, and byproducts of drugs and processes related to drug manufacturing are being more heavily scrutinized for their effect on patients and the environment. This session will examine how manufacturers, regulators, and patients can work together to balance evolving safety and environmental considerations with the need to maintain timely access to medicines. Topics will include recent developments related to HFAs, extractables and leachables, FD&C Red No. 3, and petroleum-based food dyes.
Participants:
Prabhakar Reddy, PhD
Senior Director, Pharmaceutical Science, Science-General Chapters & Complex Generics, USP
David Schoneker, M.S., IPEC – Americas
Kalpana Vanam, M.Sc.
Senior Vice President, Regulatory Affairs, Lupin Pharmaceuticals
Susan Zuk, MS
Branch Chief, OPQ, CDER, FDA
Moderator: Martin Ehlert, PhD
Vice President , Global API Technical, Apotex Inc.
