New Event!

Event Sponsor:

Extractables, Leachables, & Elemental Impurities - West Coast

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

September 15-16, 2014, Sheraton La Jolla, CA

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 Medical Devices Based on Blood Separation Technologies
  • And Much More!

Upcoming Events

Lyophilization Forum, 2014
Formulation, Cycle Optimization, & Emerging Drying Technologies
October 20-21, Racquet Club of Philadelphia

Conference Agenda Coming Soon.
Check back for details, or call (217) 721-5774 for more information.

Solubility Summit, November 2014

Details coming soon...

Why PharmaEd?

Profitable Networking

Industry innovators and established professionals meet to share ideas, forge relationships, and imagine new opportunities.

Experience You Trust

Our team has over four decades of combined experience producing conferences and delivering real value to the pharma industry.

An Industry Leader

Pharma Ed has collaborated with over 250 companies and organizations to produce some of the most informative meetings in the industry.

Our Mission

To deliver the most current, market-driven information to meet your research, product development, regulatory, quality assurance, and technical needs.

Relevant Training

Cutting-edge knowledge drawn from top pharmaceutical, biotech, and academic experts.

“"A fantastic meeting. I was interested in so many of the talks and I met several clients-current and potential.” - Principal Scientist, Aptuit SSCI

“I really enjoyed the meeting . . . Stronger speakers and more in depth coverage than some of the others on the market.”- Director, Emerson Resources, Inc.

Sponsorship Opportunities!

Sponsor a PharmaEd event and set your business apart!