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Parenteral Drug Association Connecting People, Science and Regulation ®

2016 PDA Manufacturing Science Workshop

  • Hal Baseman
    Working Session 2: New Approaches for Incorporating Process Variability to Improve Processes
  • Daniel Blackwood
    Presentation not authorized for distribution.
  • Yanxi Cain, PhD
    Working Session 5: The Role of Analytical Testing Capability in Product Lifecycle Management
  • Brett Duersch, PhD
    P1: Understanding the New Regulatory Inspections Models: Data Integrity and Manufacturing Controls & Variability
  • Paula Katz
    P1: Understanding the New Regulatory Inspections Models: Data Integrity and Manufacturing Controls and Variability
  • Gerald Leister
    P1: Understanding the New Regulatory Inspections Models: Data Integrity and Manufacturing Controls & Variability
  • Anil Sawant, PhD
    Working Session 4: Preventing Data Integrity Issues
  • Susan Schniepp & Anders Vinther, PhD
    Fishbowl -What's Holding Us Back from Improving our Processes and Methods - Challenges with Post Approval Changes?
  • Anders Vinther, PhD
    Working Session 3: Product Lifecycle Management - Facilitating Innovation and Drug Product Availability with Reduced Regulatory Burden
  • Glenn Wright
    Working Session 1: Understanding Process Variability and Identifying Areas for Process Improvement