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2023 PDA/FDA Joint Regulatory Conference

Sep 18 - Sep 20, 2023
Washington, DC

CGMP: Quality Through Science and Innovation

  • Conference
  • The Americas
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Overview

The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 32nd year. This flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. This year's theme is CGMP: Quality Through Science and Innovation.

The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized. Case studies are presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts that improve quality and benefit the consumer are also highlighted.

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Agenda

  • Day 1
  • Day 2
  • Day 3

  • MONDAY, 18 SEPTEMBER

    08:00 – 10:00 | P1: Opening Plenary

    10:00 – 10:45 | Refreshment Break in the Exhibit Area

    10:45 – 12:15 | P2

    12:30 – 13:30 | Concurrent Interest Group (IG) Sessions

    13:45 – 15:15 | Concurrent Sessions

    15:15 – 16:00 | Refreshment Break in the Exhibit Area

    16:00 – 17:30 | Concurrent Sessions

    17:45 – 18:45 | Concurrent Interest Group (IG) Sessions

    18:45 – 22:00 | Grand Opening Celebration

  • TUESDAY, 19 SEPTEMBER

    07:15 – 08:15 | Concurrent Breakfast Sessions

    08:30 – 10:15 | P3: Center Office Updates

    10:15 – 11:00 | Refreshment Break in the Exhibit Area

    11:00 – 12:45 | P4: Compliance Office Updates

    13:00 – 14:00 | Concurrent Interest Group (IG) Sessions

    14:15 – 15:45 | Concurrent Sessions

    15:45 – 16:30 | Refreshment Break in the Exhibit Area

    16:30 – 18:00 | Concurrent Sessions

  • WEDNESDAY, 20 SEPTEMBER

    07:15 – 08:15 | Concurrent Breakfast Sessions

    08:30 – 10:00 | P5: Current GMP Trends and Topics

    10:00 – 10:45 | Refreshment Break

    10:45 – 12:15 | Concurrent Sessions

    12:30 – 13:30 | Lunch with the Regulators

    13:45 – 15:15 | P6: Closing Plenary

Networking Opportunities

MONDAY, 18 SEPTEMBER

  • 10:00 – 10:45 | Refreshment Break in the Exhibit Area
  • 15:15 – 16:00 | Refreshment Break in the Exhibit Area
  • 18:45 – 22:00 | Grand Opening Celebration

TUESDAY, 19 SEPTEMBER

  • 10:15 – 11:00 | Refreshment Break in the Exhibit Area
  • 15:45 – 16:30 | Refreshment Break in the Exhibit Area
  • Open evening!

WEDNESDAY, 20 SEPTEMBER

  • 10:00 – 10:45 | Refreshment Break

Highlighted Speakers

Rick L. Friedman
Rick L. Friedman
U.S. FDA
CDR Tara Gooen Bizjak
CDR Tara Gooen Bizjak
U.S. FDA
Janeen Skutnik-Wilkinson
Janeen Skutnik-Wilkinson
Moderna
Jackie Veivia-Panter
Jackie Veivia-Panter
BioCentriq

Additional Information

  • Who Should Attend
    Departments
    • Corporate Offices, Research and Development
    • Regulatory Affairs
    • Manufacturing
    • Quality Assurance/Control
    • Marketing
    • Sales
    Job Function
    • Quality Assurance
    • Manufacturing
    • Compliance/Inspection Management
    • Supply Chain
    • Auditing
    • Executive Management
    Academia
    • Pharmaceutical sciences
    • Regulatory science
    Global Regulatory Authorities

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Livestream

Conference Elements In-Person Attendance Virtual Attendance
Plenary Sessions Yes Yes
Concurrent Sessions Yes Yes
Breakfast Sessions Yes Select sessions with audio only
Ability to Submit Questions for Q&A Yes Yes
Lunch with the Regulators Yes Yes
Interest Group Discussions with FDA Participation Yes No
Exhibit Hall Yes No
Monday Evening Networking Reception Yes No
In-Person Networking with Industry and Regulatory Participants, Presenters, and Panelists Yes No

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.


Washington, DC

  • Accommodations

    The 2023 PDA/FDA Joint Regulatory Conference hotel information will be available in March 2023.

  • Amenities

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type By 23 July In Person and Livestream 
Member $2,395
Non-Member $2,795
Gov./Health Authority/Academic (Member Only) $795
Student (Member Only) $495
Early Career Professional (Member Only) $1,295
Regular Registration
Registration Type After 23 July Livestream After 23 July In Person
Member $2,395 $2,895
Non-Member $2,795 $3,295
Gov./Health Authority/Academic (Member Only) $795 $895
Student (Member Only) $495 $595
Early Career Professional (Member Only) $1,295 $1,395

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Sponsors

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Featured Exhibitors

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Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

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Media Partners

Contact

Program Inquiries
  • Molly E. O’Neill, CMP
    Vice President
    Tel: +1 (301) 656-5900 ext. 132
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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