Conference Compendium

24th Annual Validation Week

IVT's Validation Week 2018 was held on October 22-24, 2018 in San Diego, CA. The industry’s gold standard for validation training was back to providing the most comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide.

Topics Include:

  • Engage in the two-part statistics for the non-statisticians
  • Evaluate different types of risk assessments and develop practical applications of risk management tools
  • Hear from FDA to learn from recent inspections to increase efficiencies and decrease violations
  • Learn to transition to a data-centric and agile CSV system
  • Overcome data integrity challenges and establish an enterprise-wide data governance program
  • Ensure a high-performing quality team through understanding regulation changes

Subject Matter Experts Include:

  • Connie Hetzler
    Global Head of Validation, Manufacturing Science & Technology, Alcon Laboratories, a division of Novartis
  • Maneesha Altekar
    Senior Tech Manager, Product Robustness & Analytics, AstraZeneca
  • Jeff Hanson
    Manager, Validation, Upsher-Smith
  • Lizzandra Rivera
    Associate Director, IT Quality, Alexion Pharmaceuticals
  • Michael Loiterman
    U.S. Head of Regulatory Affairs, Quality Assurance & Quality Control, Richard Wolf Medical Instruments
  • Delores Morrison
    Engineering Director, Global Validation, Edwards Life Sciences
  • Rod Freeman, BS, MS
    Global Process Owner, Process Validation, Beckman Coulter
  • Joseph Zec
    Associate Director, CSV and Compliance, Shire plc

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