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Livestream Agenda
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Livestream Agenda
Lunch with the Regulators will not be livestreamed.
All Days
Mon, Sep 8
Tue, Sep 9
Wed, Sep 10
Livestream Agenda
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Tuesday, September 9, 2025
08:30 - 10:00
ET
P3: Data Integrity at the Next Level (Potomac Ballroom)
Moderator:
Susan J. Schniepp
– Regulatory Compliance Associates Inc.
Plenary
08:30 - 10:00
ET
P3: Data Integrity at the Next Level (Potomac Ballroom)
Location: 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
A3: Effective Validation and Manufacturing Strategies (Potomac 1)
Location: 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
B3: Quality Indicators and Sustainable Compliance (Potomac 2)
Location: 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
11:00 - 12:30
ET
C3: Quality Oversight in a Modern Supply Chain (Potomac 3)
Location: 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
A4: Innovations in Facilities and Technology (Potomac 1)
Location: 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
B4: How to Make Quality Culture Real (Potomac 2)
Location: 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
14:00 - 15:30
ET
C4: Supply Chain Risk and Resilience (Potomac 3)
Location: 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
A5: Inspection Ready Facilities: Industry Practices and FDA Expectations (Potomac 1)
Location: 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
B5: Decision-Making and Knowledge Transfer (Potomac 2)
Location: 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
16:30 - 18:00
ET
C5: Evolving Release Models (Potomac 3)
Location: Potomac 3
Moderator:
Paul Z. Balcer (he/him/his)
– U.S. FDA
Supply Chain