Webinar: Overview of Guidance & Standards for Elemental Impurities (USP <232> and ICH Q3D)

Elemental impurities in drug product can have many sources, including drug substance, excipients, and packaging systems.

Original run date: Thursday, June 14, 10:00 EST | download below 

In this webinar, Smithers Rapra experts Dr. Daniel Norwood and Michael Creese will discuss:

  • The development of new standards for elemental impurities, as formalized in USP <232> and ICH Q3D.
  • Modern analytical techniques for elemental impurities.
  • Elemental extractables standards in USP, including areas that differ somewhat from the standards in USP <232>.

This webinar is the third in a 3-part series. The mission of the United States Pharmacopeia (USP) is to improve global health through public standards that ensure the quality and safety of medicines. To improve quality standards, USP has developed a series of general chapters to communicate recommendations and expectations surrounding product quality. Join Smithers Rapra experts Dr. Daniel Norwood, Dr. Andrew Feilden, and Michael Creese for a three-part webinar series providing an overview on selected USP general chapters:

Part 1: Best Practices for the Design & Conduct of Extractables and Leachables Studies based on USP <1663> and <1664>

Thursday, March 8 | 10:00 a.m. EST | 3:00 p.m. GMT

In this 45-minute webinar, Smithers Rapra experts Dr. Daniel Norwood and Dr. Andrew Feilden will provide an overview of USP general chapters <1663> and <1664>. These chapters offer best practices guidance on extractables and leachables studies.

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*Please note the change: this webinar has been rescheduled from Monday, June 4 to Thursday, June 14.

Part 2: Overview of USP Guidance & Standards for Packaging Systems

Thursday, May 3 | 10:00 a.m. EDT | 3:00 p.m. DST

In this 30-minute webinar, Dr. Norwood and Dr. Andrew Feilden will provide an overview on the USP’s recent efforts toward modernizing best practices and standards for pharmaceutical packaging. A variety of material types will be discussed, along with developments in modernizing biocompatibility standards.

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Meet the Presenters

Dr. Daniel Norwood

Dr. Norwood joined 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 Doctor of Philosophy in Environmental Chemistry from the University of North Carolina at Chapel Hill.

Dr. Andrew Feilden

Dr. Feilden has over 16 years of experience support the pharmaceutical industry. He joined Smithers Rapra in 2011 and is the Chemistry Operations Director for Extractables and Leachables in the UK, leading a team of experts at two labs in Leatherhead and Shawbury. He has a DPhil from the University of York and is a Chartered scientist and Scientific Advisor to IPAC-RS.