Webinar: Overview of USP Guidance & Standards for Packaging Systems

The United States Pharmacopeia (USP) Expert Committee for Packaging, Storage and Distribution has been in the process of modernizing pharmaceutical packaging standards of all types.

Download the recorded webinar below. Original run date: Thursday, May 3 | 10:00 a.m. EST | 3:00 p.m. BST

In this 30-minute webinar, Smithers Rapra experts Dr. Daniel Norwood and Dr. Andrew Feilden will provide a broad overview of this modernization process and discuss developing standards for plastic, rubber, glass, and other pharmaceutical packaging materials. The webinar will also discuss best practices developed by the USP and the process of modernizing biocompatibility standards for pharmaceutical packaging. There will a Q&A period at the end of the presentation.

 

This webinar is the second 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 and Dr. Andrew Feilden 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. EDT | 3:00 p.m. DST

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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Part 3: Overview of Guidance & Standards for Elemental Impurities (USP <232> and ICH Q3D)

Thursday, June 14* | 10:00 a.m. EDT | 3:00 p.m. DST

In this 30-minute webinar, Dr. Norwood and Dr. Andrew Feilden will discuss the development of new standards for elemental impurities, as formalized in USP <232> and ICH Q3D, along with issues surrounding elemental impurities.

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*Please note the date change: this webinar was rescheduled from Monday, Jue 4 to Thursday, June 14

 

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.