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Full Agenda

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Full Agenda

  • Wednesday, September 10, 2025
  • 07:00 - 08:30 ET
    Continental Breakfast (Ballroom Foyers)
  • 07:00 - 11:00 ET
    Presenter Ready Room Open (Meeting Planner Office B)
  • 07:00 - 15:00 ET
    Registration Open (Rock Creek Ballroom Registration Desk)
  • 07:15 - 08:15 ET
    Breakfast 3: Building a Strong Quality Culture (Rock Creek A)
    Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
    Breakfast Session
  • 07:15 - 08:15 ET
    Breakfast 4: Post-Approval Changes and Lifecycle Management (Rock Creek B/C)
    Moderator: Eva M. Urban, MSc (she/her/hers) – Bristol Myers Squibb
    Breakfast Session
  • 07:15 - 08:15 ET
    IG3: Data Governance, Management, Integrity, and Digitalization (Anacostia D)

    Interest Group Leader: Kir F. Henrici – The Henrici Group

    Interest Group Leader: Ulrich Koellisch, PhD – GxP-CC

  • 07:15 - 08:15 ET
    IG4: Quality Risk Management (Anacostia E)

    Interest Group Leader: Hue Kwon, PhD – SOBI

    Interest Group Leader: Amanda McFarland, MS – ValSource, Inc.

    Interest Group Leader: Malav Parikh, ME – Takeda

  • 08:30 - 10:30 ET
    P4: Agency Updates: Regulatory Priorities and Enforcement Outlook (Potomac Ballroom)
    Moderator: Karyn M. Campbell – AbbVie Inc.
    Plenary
  • 10:30 - 11:00 ET
    Networking Break (Ballroom Foyers)
  • 11:00 - 12:15 ET
    P5: Sustainable CGMP Remediation Plans and Communication: FDA Updates (Potomac Ballroom)
    Moderator: Paul Z. Balcer (he/him/his) – U.S. FDA
    Plenary
  • 12:30 - 13:45 ET
    Lunch with the Regulators (Rock Creek Ballroom)
    Moderator: Janeen Skutnik-Wilkinson (she/her/hers) – Eli Lilly and Company
    Panelist: Donald B. Ertel, MS, MT (ASCP) (he/him/his) – U.S. FDA
    Panelist: Juan Jimenez, JD – U.S. FDA
    Panelist: Jeffrey D. Meng, MSE – U.S. FDA
    Panelist: Carmelo Rosa, PsyD – U.S. FDA
    Panelist: Derek S. Smith, PhD – U.S. FDA
  • 14:00 - 15:30 ET
    P6: The “Q” Also Applies to “U” (Potomac Ballroom)
    Moderator: Irving Ford, MSc (he/him/his) – Quality Leader
    Plenary
  • 16:00 - 18:30 ET
    PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop 2025 (Rock Creek B/C) (Day 1 of 2 - Separate Registration Required)
    Post-Conference Workshop