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Full Agenda

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Full Agenda

  • Tuesday, September 9, 2025
  • 07:00 - 08:30 ET
    Continental Breakfast (Ballroom Foyers)
  • 07:00 - 16:45 ET
    Presenter Ready Room Open (Meeting Planner Office B)
  • 07:00 - 18:00 ET
    Registration Open (Rock Creek Ballroom Registration Desk)
  • 07:15 - 08:15 ET
    Breakfast 1: Fundamentals of Current Good Manufacturing Practices (Rock Creek A)
    Moderator: Erika A. Pfeiler, PhD (she/her/hers) – ValSource, Inc.
    Breakfast Session
  • 07:15 - 08:15 ET
    Breakfast 2: Using Digital Technologies to Assess and Ensure Compliance (Rock Creek B/C)
    Moderator: Lily Y. Koo, PhD – U.S. FDA
    Breakfast Session
  • 07:15 - 08:15 ET
    IG1: Quality Systems (Anacostia D)

    Interest Group Leader: Ghada N. Haddad, PhD – Kite Pharma

    Interest Group Leader: Michele Simone, PhD – Bracco

    Interest Group Leader: Eva M. Urban, MSc – Bristol Myers Squibb

  • 07:15 - 08:15 ET
    IG2: Regulatory Affairs (Anacostia E)

    Interest Group Leader: Ruhi Ahmed, PhD, RAC – FLAG Therapeutics, Inc.

  • 08:30 - 10:00 ET
    P3: Data Integrity at the Next Level (Potomac Ballroom)
    Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
    Plenary
  • 10:00 - 11:00 ET
    Networking Break in the Exhibit Area (Ballroom Foyers)
  • 10:00 - 16:30 ET
    Exhibit Area Open (Ballroom Foyers)
  • 11:00 - 12:30 ET
    A3: Effective Validation and Manufacturing Strategies (Potomac 1)
    Moderator: Nelson E. Rivera, JD – U.S. FDA
    Current Practices and Innovations
  • 11:00 - 12:30 ET
    B3: Quality Indicators and Sustainable Compliance (Potomac 2)
    Moderator: Al Kentrup (he/him/his) – NPG
    Quality Systems
  • 11:00 - 12:30 ET
    C3: Quality Oversight in a Modern Supply Chain (Potomac 3)
    Moderator: Andrew D. Hopkins, PGDip – Lachman Consultants
    Supply Chain
  • 12:30 - 14:00 ET
    Lunch on Your Own
  • 14:00 - 15:30 ET
    A4: Innovations in Facilities and Technology (Potomac 1)
    Moderator: Shawn Larson, PhD (he/him/his) – U.S. FDA
    Current Practices and Innovations
  • 14:00 - 15:30 ET
    B4: How to Make Quality Culture Real (Potomac 2)
    Moderator: Irving Ford, MSc (he/him/his) – Quality Leader
    Quality Systems
  • 14:00 - 15:30 ET
    C4: Supply Chain Risk and Resilience (Potomac 3)
    Moderator: Andrea K. Kerrigan, MS – U.S. FDA
    Supply Chain
  • 15:30 - 16:30 ET
    Networking Break in the Exhibit Area (Ballroom Foyers)
  • 16:30 - 18:00 ET
    A5: Inspection Ready Facilities: Industry Practices and FDA Expectations (Potomac 1)
    Moderator: Karyn M. Campbell – AbbVie Inc.
    Current Practices and Innovations
  • 16:30 - 18:00 ET
    B5: Decision-Making and Knowledge Transfer (Potomac 2)
    Moderator: Eva M. Urban, MSc (she/her/hers) – Bristol Myers Squibb
    Quality Systems
  • 16:30 - 18:00 ET
    C5: Evolving Release Models (Potomac 3)
    Moderator: Paul Z. Balcer (he/him/his) – U.S. FDA
    Supply Chain
  • 18:00 - 21:00 ET
    PDA Capital Area Chapter: Whiskey State of Mind – Annual Networking Social (Crimson Whiskey Bar) (Ticket Required)
  • 19:00 - 21:00 ET
    Lincoln's Last Night Walking Tour (Ticket Required)