In an effort to support industry professionals in staying up to date with these expectations, Smithers extractables and leachables experts are offering a helpful overview of selected USP general chapters this spring via a three-part webinar series.
The series combines the knowledge and experience of Smithers’ global expert staff and features Dr. Daniel Norwood, Senior Independent Consultant, and Dr. Andrew Feilden, Chemistry Operations Director. Dr. Norwood is recognized throughout the industry as a pioneer of extractables and leachables science. Dr. Feilden has extensive experience in the pharmaceutical industry and oversees two chemistry labs in the UK.
Part 1: Best Practices for the Design & Conduct of Extractables and Leachables Studies based on USP <1663> and <1664>
Thursday, March 8 | 10 a.m. EST | Download the proceedings >
Dr. Norwood and Dr. Feilden provide a general overview of these two general chapters, as well as a general look at the USP process, which helped to develop consensus regarding best practices for the design and conduct of extractables (<1663>) and leachables (<1664>) studies related to pharmaceutical dosage forms.
Part 2: Overview of USP Guidance & Standards for Packaging Systems
Thursday, May 3 | 10 a.m. EST | Register >
Dr. Norwood and Dr. Feilden will walk through the modernization process of pharmaceutical packaging and discuss developing standards for plastic, rubber, glass, and other packaging materials. They will also cover best practices developed by the USP and the process of modernizing biocompatibility standards for pharmaceutical packaging.
Part 3: Overview of Guidance & Standards for Elemental Impurities
Monday, June 4 | 10 a.m. EST | Register >
Dr. Norwood and Dr. Feilden discuss the development of new standards for elemental impurities, as formalized in USP <232> and ICH Q3D, modern analytical techniques for elemental impurities, and elemental extractables standards in USP, including areas that differ somewhat from the standards in USP <232>.
All webinars will conclude with a live Q&A segment. Slides and recorded audio will be available the day after the webinar.
Smithers Rapra is a leading authority for extractables and leachables assessments. Our experts have a proven track record of developing and delivering comprehensive extractables and leachables assessments tailored to your specific needs in our FDA registered laboratories.