Extractable & Leachable Compounds: Screening Techniques to Improve Unique Identification of Packaging Related Impurities
CEN Webinars: Stronger Bonds
Extractable & Leachable Compounds: Screening Techniques to Improve Unique Identification of Packaging Related Impurities
Tuesday March 3rd, 2015
USA 11:00am EST, 8:00 am PST, 16:00 GMT
SPEAKERS
Speaker
John Iannone
Extractables/Leachables & Special Studies
Toxikon Corporation
 
Speaker
Anja Cerstiaens PhD
Study Director Coordinator
Toxikon Corporation
 
Speaker
Peter Verleyen PhD
Technical Adviser
Toxikon Corporation
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OVERVIEW
MODERATOR
Speaker
Linda Wang
Senior Editor
C&EN
Spacer

The importance of extractable/leachable testing both for container closure systems (CCS) in the pharmaceutical industry, and materials used in medical devices, has grown considerably in the last few years. This initially was driven by well-documented incidents of impurities in the drug product, which were introduced by the container closure systems or drug delivery devices via leaching. The delivery of these impurities were found to be harmful to the patients, therefore producing a significant increase in global regulatory requirements to address such concerns.

KEY LEARNING OBJECTIVES

- Introduction – Regulatory Aspects

- Designing an Extractable & Leachable Study

- Tools to assist in Unique Identifications: Toxikon's TOX-RAY Screener Database

- High-End Analytical Techniques, used by Toxikon, which can assist in structure elucidation of a molecule

- Case Studies: Targeted and non-targeted screening

WHO SHOULD ATTEND
  • • Supply Chain Engineers
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  • • Toxicologists
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  • • Analytical Chemists
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  • • Engineers (Biomedical, Design, Manufacturing/Production, Packaging, Process, Project, Quality, R&D)
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  • • Researchers in Extractables and Leachables
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  • • Project Management
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  • • Research & Development
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