Extractables, Leachables, & Elemental Impurities 2017



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

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines, as well as the upcoming revisions to three major ISO 10993 standards. 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, and parenteral drug products. 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.

With Representation From:

  • Boehringer Ingelheim
  • Allergan
  • Pfizer
  • Genentech
  • Amgen
  • NSF Health Sciences
  • Janssen
  • Eurofins
  • Merck
  • Aspen Research
  • Lilly
  • Boston Analytical
  • Regeneron
  • West Pharmaceutical Services
  • Sanofi
  • Material Needs Consulting
  • Baxter
  • Eakins & Associates

Featuring Comprehensive Coverage On:

  • Updates & Case Studies on the Latest Compliance Implications of USP and and ICH Q3D Risk Assessment Filing Guidelines for Elemental Impurities
  • The Risk Assessment of Extractables – A Toxicological Window of Opportunity
  • BPOG’s Leachables Best Practice Guide: Study Design and Analytical Methods
  • Challenges & Consequences for the Medical Device Industry by the Revision of Three Major ISO 10993-Standards
  • Extractables Screening of Polyproylene Resins for the Identification of Suitability for Use Hazards
  • Clearance of E&L from Single-Use Technologies through Ultrafiltration/Diafiltration
  • Leachable Risk Assessment of Dosing Devices for Parenteral Applications
  • Extractables & Leachables Studies on Single-Use Components in Biomanufacturing
  • Addressing Challenges with Polysorbate 80
  • E&L Test Methodologies for Lyophilized Drug Products
  • Industry Working Group Updates: PQRI & BPOG
  • And More!
File Type

MP4, Slide Deck


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