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Webinar: Overview of Guidance & Standards for Elemental Impurities, presented by Smithers Rapra
June 14 @ 10:00 am - 10:45 am
BioOhio member Smithers Rapra, a world leader in rubber, plastics, and composites analysis, has opened registration for the final installment of its three-part webinar series providing an overview on selected United States Pharmacopeia (USP) general chapters, featuring Dr. Daniel Norwood, Independent Senior Consultant, and Michael Creese, Manager, Chemical Analysis.
The final webinar, titled “Overview of Guidance & Standards for Elemental Impurities,” will take place on Thursday, June 14, at 10 am EST. Dr. Norwood and Mr. Creese will deliver a 45-minute presentation addressing changes of note that have affected pharmaceutical packaging testing standards USP <232> and ICH Q3D. Specific considerations include:
- The development of new elemental impurities standards.
- Modern analytical techniques for elemental impurities.
- The differences between USP <232> and USP elemental extractables standards.
“Elemental impurities in drug products can originate from a variety of sources, making extractables and leachables assessments an important piece in ensuring the safety of medicines,” said Nat Leonard, President, Smithers Rapra. “Our goal with these webinars is to support the pharmaceutical industry by connecting them to experts like Daniel and Michael who each have years of experience in these assessments and represent the global footprint of our analytical services expertise.”
Dr. Norwood partnered with Smithers in 2017 as a Senior Independent Consultant. He has over 41 years of experience in chemistry and pharmaceutical research and is recognized throughout the industry as a pioneer of extractables and leachables science. In addition to extractables and leachables analysis, his areas of expertise include structural analysis of pharmaceutical impurities and degradation products. He has a Doctorate of Philosophy in Environmental Chemistry from the University of North Carolina at Chapel Hill.
Mr. Creese joined Smithers in 2009. He has worked in extractables and leachables assessments both with biopharmaceuticals and pharmaceuticals for over 11 years. He uses his expertise to solve the challenges of single use system suppliers and users, as well as final container closure systems. Mr. Creese has a Bachelor of Science in Chemistry and is a Member of the Royal society of Chemistry (MRSC).
Click here to register for this upcoming webinar. For those who are unable to make the live version, Smithers will publish recordings available for download at www.smithersrapra.com/resources. You can also access the previous webinars from this series:
- Part 1: Best Practices for the Design & Conduct of Extractables and Leachables Studies based on USP <1663> and <1664>.
Smithers offers a unique set of services in support of the development of medical devices or pharmaceutical packaging, from materials selection and assessments to final product performance, packaging integrity, and regulatory submissions. Visit www.smithersrapra.com to learn more about Smithers’ full range of medical and pharmaceutical testing services.