New Events!

Event Sponsors:

Lyophilization Forum 2014

Formulation, Cycle Optimization, & Emerging Drying Technologies

October 20-21, Racquet Club of Philadelphia, PA

Featuring Representation From:

  • Merck
  • Novartis
  • Baxter
  • Medimmune
  • SP Scientific
  • Novo Nordisk
  • Lyophilization Technology
  • GEA Lyophil
  • Ima Life
  • West
  • Millrock Technology
  • AB BioTechnologies
  • LIGHTHOUSE Instruments
  • NIBSC
  • PSD, Inc
  • NIST

Featuring Comprehensive Coverage On:

  • Case Studies in Controlled Nucleation
  • Stabilization and Drying Techniques for Complex Proteins & Biologics
  • Developing a Lab-scale Model for Life-cycle Management of a Marketed Vaccine
  • Creating a Design Space for Secondary Drying
  • DoE Approaches within Lyophilization Formulation & Process Development
  • Predicting the Stability of Lyophilized Sugar Glasses by Fluorescence Stokes Shift
  • QbD and PAT in Developing a Spray Drying Process
  • Understanding Phase Behavior of Ice During Lyophilization
  • Lyophilized Drug Product Development using QbD Principles
  • Product Behavior During Lyo when Processed in Dual Chamber Cartridges vs. Tubing Vials
  • Freeze Drying PAT using Heat Flux Measurement
  • Spray Drying Challenges-Lab Scale Formulation to Pilot Scale Up
  • Container Closure Systems for Optimal Lyophilized Product Stability & Processing
  • Moisture Monitoring, Inspection, & Tracing Methods for Lyophilized Vials
  • And Much More!


Register by September 10th and save $300!


Event Sponsors:

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

Solubility & Bioavailability Summit 2014

Exploring New Strategies for Optimizing Bioavailability of Current and Future Drug Products
December 4-5, Racquet Club of Philadelphia, PA

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

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