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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

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) – Moderna
Panelist: Donald B. Ertel, MS, MT (ASCP) (he/him/his) – U.S. FDA
Panelist: Juan Jimenez, JD – U.S. Food and Drug Administration, CVM, CGMP Compliance
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