Join USP for an engaging presentation and discussion covering the latest approaches to organic impurity analysis, regulatory expectations, and practical applications of USP Reference Standards and scientific solutions to support pharmaceutical quality.
This webinar will provide a brief introduction and background to impurities in drug substances and products. Major ICH Guidelines on impurities will be explained on a high level, as well as other guidelines derived from them, before diving into the respective USP quality standards around organic impurities. Regulatory expectations will be discussed based on publicly available real case examples as well as caveats while testing impurities or developing/validating methods for impurity analysis.
Register for this webinar
We will discuss real cases where the FDA, via publicly available Complete Response Letters, required resubmission of an application (or other action) based, in part, on deficiencies related to information provided for organic impurities, including nitrosamines and extractables/leachables. Real cases also build the background for caveats during testing on impurities.
Solutions presented by USP will be followed by a Q&A session at the end of the webinar.
What you will learn:
- Select FDA expectations and considerations on impurity testing and qualification
- Real-world examples of the impacts/limitations of using non-compendial reference materials in impurity analysis.
- Solutions provided by USP
Secure your place today
Christian Zeine is Senior Scientific Affairs Manager, EMEA, US Pharmacopeia
Christian joined USP in 2019 as Senior Manager in the Scientific Affairs Group for the EMEA region, with a focus on Small Molecules, USP’s General Chapters and Impurities. Christian collaborates with scientific experts and stakeholders and is responsible for protecting and growing USP’s scientific reputation in the region and globally. Before joining USP, Christian worked for seventeen years in the field of pharmaceutical reference standards with a focus on impurities, and before that in the IVD (In Vitro Diagnostic) industry. His scientific expertise includes impurity testing, reference standards characterization and adjacent fields. Christian has published several articles and white papers on topics such as impurities, overview of (certified) reference materials and the use of reference standards in method development and validation. Christian earned his Ph.D. degree in Organosilicon Chemistry from the University of Muenster, Germany.
Is the panel discussion free?
Yes – there is no charge to watch the panel discussion, either live or on-demand.
When will the panel discussion take place?
The webinar will be taking place on 23rd September 2026 at 2pm (BST).
Can I watch it later?
The panel discussion will become available to watch on-demand shortly after the live webinar takes place.
What are the benefits of attending live?
You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session.
How long will the panel discussion be?
This panel discussion will last up to an hour.
What do I need to watch this panel discussion?
All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.
