Skip to main content
PDA Regulatory Conference 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Livestream Agenda

  1. Home
  2. Livestream Agenda
  

    Lunch with the Regulators will not be livestreamed.

Livestream Agenda

  • Monday, September 8, 2025
  • 08:30 - 10:00 ET
    P1: Quality in Advanced Therapies and Global Collaboration (Potomac Ballroom)
    Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
    Plenary
  • 11:00 - 12:30 ET
    P2: Current GMP Compliance Trends and Topics (Potomac Ballroom)
    Moderator: Erika A. Pfeiler, PhD (she/her/hers) – ValSource, Inc.
    Plenary
  • 14:00 - 15:30 ET
    A1: Competency-Based Training and Digital Learning (Potomac 1)
    Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
    Current Practices and Innovations
  • 14:00 - 15:30 ET
    B1: Data Integrity (Potomac 2)
    Moderator: Al Kentrup (he/him/his) – NPG
    Quality Systems
  • 14:00 - 15:30 ET
    C1: Beyond Your Facility Walls: Contractor and Supplier Quality Oversight (Potomac 3)
    Supply Chain
  • 16:30 - 18:00 ET
    A2: Leveraging AI in Audits (Potomac 1)
    Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
    Current Practices and Innovations
  • 16:30 - 18:00 ET
    B2: Knowledge Sharing Best Practices (Potomac 2)
    Moderator: Marc Glogovsky, MS – ValSource, Inc.
    Quality Systems
  • 16:30 - 18:00 ET
    C2: From Disruption to Preparedness: Achieving Sustainable Supply Through Crisis Management and Proactive Compliance (Potomac 3)
    Supply Chain
  • Tuesday, September 9, 2025
  • 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
  • 08:30 - 10:00 ET
    P3: Data Integrity at the Next Level (Potomac Ballroom)
    Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
    Plenary
  • 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
  • 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
  • 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
  • Wednesday, September 10, 2025
  • 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
  • 08:30 - 10:30 ET
    P4: Agency Updates: Regulatory Priorities and Enforcement Outlook (Potomac Ballroom)
    Moderator: Karyn M. Campbell – AbbVie Inc.
    Plenary
  • 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