Risks in pharmaceutical quality – the role of reference standards in analytical procedures
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16 July 2025
12:00pm
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Join this webinar to learn about the essential role of Reference Standards in mitigating risks to pharmaceutical quality.
Ensuring analytical procedures are accurate, precise, and robust from early development to product release is crucial for quality medicines. Robust procedures can detect variability and inconsistencies between batches, which is vital for identifying and addressing any issues early in the process.
This is also critical for demonstrating to regulatory authorities that the procedures are reliable and produce consistent results across different process stages and batches. Reference Standards are an integral part of such analytical procedures.
In the complex landscape of pharmaceutical development and compliance, ensuring the highest quality of products is paramount, and accurate measurements are at the heart of pharmaceutical quality assessment.
This webinar provides practical examples on how inaccurate measurements can influence the reliability of analytical results and lead to erroneous conclusions about product quality and safety.
Experts will discuss the risks in analytical procedures due to improperly used or insufficiently qualified Reference Standards. They will also share insight on how to mitigate these risks through proper setup, handling, and use. Emphasis will be placed on the need for a Reference Standard to remain suitable-for-use throughout its life cycle.
Key learning points
- Learn the risks to pharmaceutical quality and the impact of the use of non-fit for use RS and analytical procedures
- Gain insights into how inaccurate measurements can lead to erroneous conclusions about product quality and safety
- Understand the critical stages of Reference Standards development process: What is suitability for use and how to minimise risks to quality.
OUR SPEAKER
Christian Zeine – Senior Manager Scientific Affairs, 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. 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, characterisation and adjacent fields. He 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 PhD degree in Organosilicon Chemistry from the University of Muenster, Germany.
FAQs
FAQs
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?
16 July at 1pm 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.
