New Events!


Event Sponsors:

Extractables, Leachables, & Elemental Impurities

September 14-15, 2015, Racquet Club of Philadelphia, PA

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:

  • Updates & Case Studies on the Latest Compliance Implications of USP and ICH Guidelines for Elemental Impurities
  • Development and Justification of a Risk Evaluation Matrix to Guide Testing Necessary to Select and Qualify Plastic Components used in Production Systems for Pharmaceutical
  • Systematic Extractable Risk Assessment of Polymeric Product Contact Materials in the Manufacturing and Packaging of Biologics
  • Materials Characterization and Extractables and Leachables: Designing and Executing Studies
  • Safety Assessment of Leachables
  • Managing the Risks of Leachables from Single-Use Processing Equipment
  • Extractables & Leachables Considerations in the Qualification and Validation of Single-Use Systems
  • An Approach for E&L Evaluations of High Risk Infusion Devices
  • Practical Approaches for Extractables/Leachables Study and Toxicological Assessment for Printing Inks for Large Volume Parenteral Drug Products
  • And Much More!


Early Bird Special: Register Before July 15th and Save $200!


Event Sponsor:

Process Validation Summit 2015

October 5-6, 2015, Sheraton La Jolla, CA

Are you compliant with FDA requirements for process validation? This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

With Representation From:

  • FDA
  • Abbott
  • Bayer
  • Genzyme
  • Hospira
  • Parexel
  • QPharma
  • Apotex
  • Arlenda
  • BIOVIA
  • VolPal
  • ProPharma Group
  • Snee Associates
  • PharmaTech Associates
  • BergumSTATS

Featuring Comprehensive Coverage On:

  • FDA Process Validation and Risk Management Approaches
  • Lifecycle Approach to Process Validation
  • Global Technology Transfer and Process Validation
  • Achieving the Business and Compliance Benefits of Quality by Design (QbD) and Continued Process Verification (CPV)
  • Legacy Products - From Retrospective to Prospective Process Validation
  • Validation Sampling Plans and Statistical Process Control
  • Cost-effective Process Validation Lifecycle Management
  • Implementing a Comprehensive Strategy for Process Validation: Stage 3, Continued Process Verification
  • Establishing a Continuum of Criticality for Process Parameters and Quality Attributes Throughout the Lifecycle
  • And Much More!


Early Bird Pricing: Register by June 15th and save $200!


Upcoming Events

Solubility & Bioavailability Summit

November 5-6, 2015
Racquet Club of Philadelphia, PA

Agenda Coming Soon!

Early Bird registration available. Call Kim for details: (217) 721-5774.

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