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Full Agenda

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Full Agenda

  • Sunday, September 7, 2025
  • 11:30 - 13:00 ET
    Advisory Board Luncheon (River Birch A) (Invite Only)
  • 13:00 - 17:00 ET
    Advanced Therapy Medicinal Products Advisory Board (MR 14) (Invite Only)
    AB Chair: Friedrich von Wintzingerode, PhD (he/him/his) – Genentech, a Member of the Roche Group
    AB Vice-Chair: Monica Markovski Commerford, PhD – Thermo Fisher Scientific
  • 13:00 - 17:00 ET
    Biopharmaceutical Advisory Board (MR 15) (Invite Only)
    AB Chair: Maxwell De Long, MS, MechE (he/him/his) – Genentech
    AB Vice-Chair: Peter J. Makowenskyj, MEng – G-CON
  • 13:00 - 17:00 ET
    Regulatory Affairs and Quality Advisory Board (MR 16) (Invite Only)
    AB Chair: Eva M. Urban, MSc (she/her/hers) – Bristol Myers Squibb
    AB Vice-Chair: Vinny Browning, MS – Amgen
  • 13:00 - 17:00 ET
    Science Advisory Board (MR 13) (Invite Only)
    AB Chair: Ivy Louis, MPharm, MBA(HRM) – Vienni Training & Consulting LLP
    AB Vice-Chair: Ken Paddock – Merz Aesthetics
  • 14:00 - 19:00 ET
    Registration Open (Rock Creek Ballroom Registration Desk)
  • 15:00 - 18:00 ET
    Presenter Ready Room Open (Meeting Planner Office B)
  • 16:00 - 17:30 ET
    PDA Capital Area Chapter Roundtable: FDA Complete Response Letters: A Growing Industry Challenge with Big Impacts (Rock Creek B)
    Moderator: Glenn E. Wright, MA – PDA
  • Monday, September 8, 2025
  • 07:00 - 08:30 ET
    Continental Breakfast (Ballroom Foyers)
  • 07:00 - 16:15 ET
    Presenter Ready Room Open (Meeting Planner Office B)
  • 07:00 - 19:00 ET
    Registration Open (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
  • 10:00 - 11:00 ET
    Networking Break in the Exhibit Area (Ballroom Foyers)
  • 10:00 - 16:30 ET
    Exhibit Area Open (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
  • 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
    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
  • 15:30 - 16:30 ET
    Networking Break in the Exhibit Area (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
    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
  • 18:00 - 20:00 ET
    Networking Reception (Rock Creek Ballroom)
  • Tuesday, September 9, 2025
  • 07:00 - 08:30 ET
    Continental Breakfast (Ballroom Foyers)
  • 07:00 - 16:45 ET
    Presenter Ready Room Open (Meeting Planner Office B)
  • 07:00 - 18:00 ET
    Registration Open (Rock Creek Ballroom Registration Desk)
  • 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
  • 07:15 - 08:15 ET
    IG1: Quality Systems (Anacostia D)

    Interest Group Leader: Ghada N. Haddad, PhD – Kite Pharma

    Interest Group Leader: Michele Simone, PhD – Bracco

    Interest Group Leader: Eva M. Urban, MSc – Bristol Myers Squibb

  • 07:15 - 08:15 ET
    IG2: Regulatory Affairs (Anacostia E)

    Interest Group Leader: Ruhi Ahmed, PhD, RAC – FLAG Therapeutics, Inc.

  • 08:30 - 10:00 ET
    P3: Data Integrity at the Next Level (Potomac Ballroom)
    Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
    Plenary
  • 10:00 - 11:00 ET
    Networking Break in the Exhibit Area (Ballroom Foyers)
  • 10:00 - 16:30 ET
    Exhibit Area Open (Ballroom Foyers)
  • 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
  • 12:30 - 14:00 ET
    Lunch on Your Own
  • 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
  • 15:30 - 16:30 ET
    Networking Break in the Exhibit Area (Ballroom Foyers)
  • 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
  • 18:00 - 21:00 ET
    PDA Capital Area Chapter: Whiskey State of Mind – Annual Networking Social (Crimson Whiskey Bar) (Ticket Required)
  • 19:00 - 21:00 ET
    Lincoln's Last Night Walking Tour (Ticket Required)
  • Wednesday, September 10, 2025
  • 07:00 - 08:30 ET
    Continental Breakfast (Ballroom Foyers)
  • 07:00 - 11:00 ET
    Presenter Ready Room Open (Meeting Planner Office B)
  • 07:00 - 15:00 ET
    Registration Open (Rock Creek Ballroom Registration Desk)
  • 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
  • 07:15 - 08:15 ET
    IG3: Data Governance, Management, Integrity, and Digitalization (Anacostia D)

    Interest Group Leader: Kir F. Henrici – The Henrici Group

    Interest Group Leader: Ulrich Koellisch, PhD – GxP-CC

  • 07:15 - 08:15 ET
    IG4: Quality Risk Management (Anacostia E)

    Interest Group Leader: Hue Kwon, PhD – SOBI

    Interest Group Leader: Amanda McFarland, MS – ValSource, Inc.

    Interest Group Leader: Malav Parikh, ME – Takeda

  • 08:30 - 10:30 ET
    P4: Agency Updates: Regulatory Priorities and Enforcement Outlook (Potomac Ballroom)
    Moderator: Karyn M. Campbell – AbbVie Inc.
    Plenary
  • 10:30 - 11:00 ET
    Networking Break (Ballroom Foyers)
  • 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
  • 16:00 - 18:30 ET
    PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop 2025 (Rock Creek B/C) (Day 1 of 2 - Separate Registration Required)
    Post-Conference Workshop
  • Thursday, September 11, 2025
  • 07:00 - 16:00 ET
    Registration Open | PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop (Rock Creek Ballroom Registration Desk)
  • 08:00 - 16:00 ET
    PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop 2025 (Rock Creek B/C) (Day 2 of 2 - Separate Registration Required)
    Post-Conference Workshop
  • 08:30 - 16:00 ET
    Aseptic Processing Essentials Workshop (MR 13) (Separate Registration Required)
    Instructor: Hal Baseman, MBA – ValSource, Inc.
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course (MR 14) (Day 1 of 2, Separate Registration Required)
    Instructor: John Geigert, PhD – BioPharmaceutical Quality Solutions
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    Contamination Control Strategy Essentials Workshop (MR 12) (Separate Registration Required)
    Instructor: Frederic B. Ayers (he/him/his) – ValSource, Inc.
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    Fundamentals of Quality Risk Management Training Course (MR 15) (Separate Registration Required)
    Instructor: Virginia Andreotti-Jones (she/her/hers) – ValSource, Inc.
    Instructor: Tiffany A. Baker, MBA (she/her/hers) – ValSource, Inc.
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    GxP Auditing Logistics and Inspection Readiness Training Course (Including Mock Activity) (MR 16) (Day 1 of 2, Separate Registration Required)
    Instructor: Iris J. Lugo Irizzary – Amgen
    Instructor: Jeaneen C. Wallis, MBA, PhD – J. Wallis Consulting
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    Measuring Quality Culture using PDA's Assessment Tool Training Course (MR 10) (Separate Registration Required)
    Instructor: Danielle Duran, MA – Nestlé Health Science
    Instructor: Amanda McFarland, MS (she/her/hers) – ValSource, Inc.
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    Quality and Compliance Management for Virtual Companies Training Course (MR 15) (Day 1 of 2, Separate Registration Required)
    Instructor: Kevin J. Slatkavitz, PhD – ThinkQuality, LLC
    PDA Training and Research Institute
  • Friday, September 12, 2025
  • 08:30 - 16:00 ET
    CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course (MR 14) (Day 2 of 2, Separate Registration Required)
    Instructor: John Geigert, PhD – BioPharmaceutical Quality Solutions
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    GxP Auditing Logistics and Inspection Readiness Training Course (Including Mock Activity) (MR 16) (Day 2 of 2, Separate Registration Required)
    Instructor: Iris J. Lugo Irizzary – Amgen
    Instructor: Jeaneen C. Wallis, MBA, PhD – J. Wallis Consulting
    PDA Training and Research Institute
  • 08:30 - 16:00 ET
    Quality and Compliance Management for Virtual Companies Training Course (MR 15) (Day 1 of 2, Separate Registration Required)
    Instructor: Kevin J. Slatkavitz, PhD – ThinkQuality, LLC
    PDA Training and Research Institute