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Livestream Agenda

  
    Lunch with the Regulators will not be livestreamed.

Livestream Agenda

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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)
Moderator: Tara Gooen Bizjak, MBS (she/her/hers) – U.S. FDA
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)
Moderator: Janeen Skutnik-Wilkinson (she/her/hers) – Moderna
Supply Chain