gallery 1
Impurities Profile Management in the Pharmaceutical Product Life Cycle
September 20, 2017 | Toronto, Canada
October 18, 2017 | Montreal, Canada
Conference Agenda:
  • 8:30 AM – 9:00 AM
  • Registration, Networking and Continental Breakfast

  • 9:00 AM – 9:15 AM
  • Introduction

    Natasha Demberg, BSc, MSc , Vice President of Pharmaceutical Solutions, Neopharm Labs


  • 9:15 AM - 10:15 AM
  • Impurity profiling and the impact of analytical method development

    Jeffrey P. Kiplinger, PhD , Founder and General Manager, Averica & VP Science and Innovation, Neopharm Labs

    • Best practices in profiling

    • Method development and mass balance

    • Related substances and exogenous impurities

    • Phase-appropriate knowledge of impurities


  • 10:15 AM - 10:40 AM
  • Mid-morning Refreshment Break & Exhibition viewing

  • 10:40 AM – 11:40 AM
  • Drug Substance Excipient Interactions

    Steven Baertschi, PhD , President, Baertschi Consulting, LLC

    • Regulatory requirements for DS and DP

    • The role of stress degradation in stability studies

    • Excipient interactions and potential impurities


  • 12:00 PM - 1:15 PM
  • Networking Lunch

  • 1:15 PM – 2:15 PM
  • Manufacturing: Elemental Impurities (ICP/MS testing)

    Diego A. Zurbriggen, Supervisor, Analytical Laboratory, West Pharmaceutical Services, Inc.

    • USP 232/233 and their impact on you

    • Methodologies

    • Phase-appropriate testing


  • 2:15 PM - 3:15 PM
  • Product integrity: Extractable and Leachable determination

    Mathieu Fournier, MSc, Supervisor, Analytical R&D, Neopharm Labs

    • USP guidance: <1663> and <1664>

    • General Considerations for Extractables & Leachables

    • Evaluation of Extractables

    • Leachables Assessment


  • 3:15 – 3:45 PM
  • Refreshment, Networking, and Exhibition break

  • 3:45 PM – 4:45 PM
  • Commercial Product Stability Assessment and Testing

    Kenneth C. Waterman, Ph.D. President, FreeThink Technologies, Inc.

    • Regulatory guidance on product stability assessment

    • Analytical methodologies and stability protocols

    • Special conditions

    • Modeling of drug product stability


    • 4:45 PM – 5:00 PM
    • Questions and Answers and discussions
      Natasha Demberg, BSc, MSc , Vice President of Pharmaceutical Solutions, Neopharm Labs


    • 5:00 PM
    • Conclusion of Program


  • Note: Agenda is subject to change without notice. Please check back regularly for updates.