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Monday, September 8, 2025
07:00 - 08:30
ET
Continental Breakfast (Ballroom Foyers)
07:00 - 08:30
ET
Continental Breakfast (Ballroom Foyers)
Location: Ballroom Foyers
07:00 - 16:15
ET
Presenter Ready Room Open (Meeting Planner Office B)
07:00 - 16:15
ET
Presenter Ready Room Open (Meeting Planner Office B)
Location: Meeting Planner Office B
07:00 - 19:00
ET
Registration Open (Rock Creek Ballroom Registration Desk)
07:00 - 19:00
ET
Registration Open (Rock Creek Ballroom Registration Desk)
Location: Rock Creek Ballroom Registration Desk
08:30 - 10:00
ET
P1: Quality in Advanced Therapies and Global Collaboration (Potomac Ballroom)
Moderator:
Mary E. Farbman, PhD
– Merck & Co., Inc.
Plenary
08:30 - 10:00
ET
P1: Quality in Advanced Therapies and Global Collaboration (Potomac Ballroom)
Location: Potomac Ballroom
Moderator:
Mary E. Farbman, PhD
– Merck & Co., Inc.
Plenary
08:30 - 08:50
ET
Welcome and Opening Remarks from PDA Leadership and the Conference Co-Chairs
Location: Potomac Ballroom
Board Chair:
Anil D. Sawant, PhD
– Merck & Co., Inc.
President & CEO:
Glenn E. Wright, MA
– PDA
Co-Chair:
Janeen Skutnik-Wilkinson (she/her/hers)
– Moderna
Co-Chair:
Mary E. Farbman, PhD
– Merck & Co., Inc.
Plenary
08:50 - 09:10
ET
The Power of Quality
Location: Potomac Ballroom
Presenter:
Melissa S. Seymour, MBA
– Eli Lilly and Company
Plenary
09:10 - 09:30
ET
The Human Impact
Location: Potomac Ballroom
Presenter:
Jimi Olaghere
– Sugarloaf Capital
Plenary
09:30 - 10:00
ET
Q&A
Location: Potomac Ballroom
Plenary
10:00 - 11:00
ET
Networking Break in the Exhibit Area (Ballroom Foyers)
10:00 - 11:00
ET
Networking Break in the Exhibit Area (Ballroom Foyers)
Location: Ballroom Foyers
10:00 - 16:30
ET
Exhibit Area Open (Ballroom Foyers)
10:00 - 16:30
ET
Exhibit Area Open (Ballroom Foyers)
Location: Ballroom Foyers
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
11:00 - 12:30
ET
P2: Current GMP Compliance Trends and Topics (Potomac Ballroom)
Location: Potomac Ballroom
Moderator:
Erika A. Pfeiler, PhD (she/her/hers)
– ValSource, Inc.
Plenary
11:00 - 11:25
ET
Drug Compliance Trends and Topics
Location: Potomac Ballroom
Presenter:
Francis R.W. Godwin, MBA
– U.S. FDA
Plenary
11:25 - 11:50
ET
Biologics Compliance Trends and Topics
Location: Potomac Ballroom
Presenter:
Jonathan G. Swoboda, PhD (he/him/his)
– U.S. FDA
Plenary
11:50 - 12:30
ET
Q&A with Additional Panelists
Location: Potomac Ballroom
Panelist:
Jeffrey D. Meng, MSE
– U.S. FDA
Panelist:
Dillard H. Woody
– U.S. FDA
Plenary
12:30 - 14:00
ET
Lunch on Your Own
12:30 - 14:00
ET
Lunch on Your Own
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
A1: Competency-Based Training and Digital Learning (Potomac 1)
Location: Potomac 1
Moderator:
Susan J. Schniepp
– Regulatory Compliance Associates Inc.
Current Practices and Innovations
14:00 - 14:25
ET
Training for Performance
Location: Potomac 1
Presenter:
Marc Glogovsky, MS
– ValSource, Inc.
Current Practices and Innovations
14:25 - 14:50
ET
Digital Tools for Smarter Learning
Location: Potomac 1
Presenter:
Richard Jaenisch, MPH
– Open Biopharma Research and Training Institute
Current Practices and Innovations
14:50 - 15:30
ET
Q&A with Additional Panelist
Location: Potomac 1
Panelist:
Matthew R. Dionne, PharmD, MBA, BCPS
– U.S. FDA
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
B1: Data Integrity (Potomac 2)
Location: Potomac 2
Moderator:
Al Kentrup (he/him/his)
– NPG
Quality Systems
14:00 - 14:25
ET
DI: The Unbreakable Chain – Is Yours Strong Enough?
Location: Potomac 2
Presenter:
Alicja Wolska, MS (she/her/hers)
– Merck & Co., Inc.
Quality Systems
14:25 - 14:50
ET
Data Governance to Ensure Regulatory Compliance, Data Protection, and Future Readiness for Advanced Use Cases
Location: Potomac 2
Presenter:
Toni Manzano, PhD (he/him/his)
– Aizon
Quality Systems
14:50 - 15:30
ET
Q&A
Location: Potomac 2
Panelist:
Shawn Larson, PhD (he/him/his)
– U.S. FDA
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
14:00 - 15:30
ET
C1: Beyond Your Facility Walls: Contractor and Supplier Quality Oversight (Potomac 3)
Location: Potomac 3
Moderator:
Tara Gooen Bizjak, MBS (she/her/hers)
– U.S. FDA
Supply Chain
14:00 - 14:25
ET
Building Sustainable Contractor Relationships That Deliver Value
Location: Potomac 3
Presenter:
Jennifer Stone, MBA
– PTC Therapeutics
Supply Chain
14:25 - 14:50
ET
Selecting Suppliers and Monitoring Lifecycle Signals
Location: Potomac 3
Presenter:
Shaun Crofts
– Gilead
Supply Chain
14:50 - 15:30
ET
Q&A with Additional Panelist
Location: Potomac 3
Panelist:
Benjamin Mills
– Rx-360
Supply Chain
15:30 - 16:30
ET
Networking Break in the Exhibit Area (Ballroom Foyers)
15:30 - 16:30
ET
Networking Break in the Exhibit Area (Ballroom Foyers)
Location: Ballroom Foyers
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
A2: Leveraging AI in Audits (Potomac 1)
Location: Potomac 1
Moderator:
Mary E. Farbman, PhD
– Merck & Co., Inc.
Current Practices and Innovations
16:30 - 16:55
ET
Enhancing Audit Readiness Through Digital Tools
Location: Potomac 1
Presenter:
Nidia Acevedo, PhD
– Eli Lilly and Company
Current Practices and Innovations
16:55 - 17:20
ET
Navigating Implementation Challenges for Emerging Technologies
Location: Potomac 1
Presenter:
Vinny Browning, MS
– Amgen
Current Practices and Innovations
17:20 - 18:00
ET
Q&A with Additional Panelist
Location: Potomac 1
Panelist:
Hesha J. Duggirala, PhD, MPH (she/her/hers)
– U.S. FDA
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
B2: Knowledge Sharing Best Practices (Potomac 2)
Location: Potomac 2
Moderator:
Marc Glogovsky, MS
– ValSource, Inc.
Quality Systems
16:30 - 16:55
ET
The Culture We Want to Grow: Collaborating for Consistency in Global Sterility Assurance
Location: Potomac 2
Presenter:
Rebecca D. Jordan (she/her/hers)
– Bristol Myers Squibb
Quality Systems
16:55 - 17:20
ET
Concept: A Self-Sustaining Sterility Assurance Program is a Journey
Location: Potomac 2
Presenter:
Christopher A. Murdock, PhD, CQA
– Eli Lilly and Company
Quality Systems
17:20 - 18:00
ET
Q&A with Additional Panelist
Location: Potomac 2
Panelist:
Brooke K. Higgins, MS
– ELIQUENT Life Sciences
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
16:30 - 18:00
ET
C2: From Disruption to Preparedness: Achieving Sustainable Supply Through Crisis Management and Proactive Compliance (Potomac 3)
Location: Potomac 3
Moderator:
Janeen Skutnik-Wilkinson (she/her/hers)
– Moderna
Supply Chain
16:30 - 16:55
ET
Resilient by Design: A Case Study in Rapid Recovery
Location: Potomac 3
Presenter:
Chad Minks, MBA
– Baxter
Supply Chain
16:55 - 17:20
ET
Proactive Compliance and Maturity
Location: Potomac 3
Presenter:
Carmen C. Araujo, MBA (she/her/hers)
– Takeda
Supply Chain
17:20 - 18:00
ET
Q&A with Additional Panelist
Location: Potomac 3
Panelist:
Derek S. Smith, PhD
– U.S. FDA
Panelist:
Ivy E. Sweeney, PhD (she/her/hers)
– U.S. FDA
Supply Chain
18:00 - 20:00
ET
Networking Reception (Rock Creek Ballroom)
18:00 - 20:00
ET
Networking Reception (Rock Creek Ballroom)
Location: Rock Creek Ballroom
