PDA New England: A Life Cycle Approach to the Stability Testing of Biopharmaceutical Drug Products

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The New England Chapter of the PDA is excited to offer the 27th in our webinar series on A Life Cycle Approach to the Stability Testing of Biopharmaceutical Drug Products.

Dr. Tony Cundell consults with several pharmaceutical consumer health dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories, and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories as the Senior Principal Scientist in early phase drug development. Earlier in his career Tony worked at a director level at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough. Dr. Cundell is a member of the 2020-2025 U.S.P. Microbiology Committee of Experts where he takes a leadership role in microbiology methods. He has authored numerous publications in many areas of the pharmaceutical industry. He received the 2022 Gordon Personeus Award for long term contributions of special importance to the PDA.

Areas Covered:

  • Global Stability Regulatory and Guidance Documents with Emphasis on Biologics (FDA Points to Consider and ICH Q1 A through F)
  • Release versus Stability Testing
  • Sterility Test Parameters and Time Intervals
  • Liquid, Frozen and Lyophilized Products
  • Accelerated and Long-Term Stability Study Protocols
  • Setting Storage Conditions and Product Expiration Dating
  • Statistical Analysis of Stability Data
  • Response to Projected and Actual Stability Failures
  • Case Histories, e.g., Insulin (peptide hormone), Humira® (monoclonal antibody), Hepatitis B vaccine (recombinant HBsg), and Zolgensma® (gene therapy)

This webinar will benefit:

  • Stability Project Managers
  • Analytical Method Development
  • Project and Process Development
  • Packaging Specialists
  • All QC and QA Personnel
  • Regulatory Affairs

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