Extractables, Leachables, & Elemental Impurities – West Coast



Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics

Featuring Representation From:

  • FDA
  • Bristol-Myers Squibb
  • Eli Lilly & Co.
  • Janssen R&D – A Pharmaceutical Company of Johnson & Johnson
  • Amgen
  • Boehringer Ingelheim
  • West Pharmaceutical Services
  • BD
  • Baxter Healthcare Services
  • B. Braun Medical
  • VR Analytical
  • Bausch+Lomb
  • Fresenius Kabi
  • Exova
  • Toxikon
  • Aspen Research
  • Eakins & Associates
  • Material Needs Consulting

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.

Featuring Comprehensive Coverage On:

  • Meeting Qualification and Compliance Implications of USP and and ICH Guidelines for Elemental Impurities
  • Industry Working Group Updates: The PQRI Leachables and Extractables Considerations for Parenteral and Ophthalmic Drug Products
  • Industry Working Group Updates: The BPOG’s Extractables Protocols for Singe-Use Technologies
  • Total and Extractable Elemental Impurities In Plastic Materials and Systems: A Literature Review
  • Analysis of Extractables & Leachables: Past, Present and Future Trends
  • Extractable Study Design and Data Evaluation of Polymeric Product Materials
  • Safety Assessment of Leachables for Parenteral Drug Products
  • Managing the Risks of Leachables from Single-Use Processing Equipment
  • Strategic Application of Analytical Methods for Extractables Evaluations
  • Extractables & Leachables Considerations in the Qualification and Validation of Single-Use Systems
  • E/L Studies for Medi
File Type

MP4, Slide Deck


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