PDA/FDA Joint Regulatory Conference 2024

GMP: Leading with Quality and Integrity

Washington, DC
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Celebrate the 33rd annual PDA/FDA Joint Regulatory Conference this September!

This CGMP conference will emphasize 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 vital role of robust quality systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized as fundamental to CGMP compliance.

Case studies presented throughout the conference will provide practical insights and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts to improve quality and benefit consumers will also be highlighted.

Program Planning Committee

  • Milind Ganjawala, U.S. FDA (Co-Chair)
  • Janeen Skutnik-Wilkinson, Moderna (Co-Chair)
  • Denyse Baker, Eli Lilly and Company
  • Paul Balcer, U.S. FDA
  • Tara Gooen Bizjak, U.S. FDA
  • Francesco Cicirello, BioNTech
  • Dan DeCiero, U.S. FDA
  • Nicole Deschamps, GSK
  • Becky Dowd, U.S. FDA
  • Mary Farbman, Merck & Co., Inc.
  • Irving Ford, Adaptimmune
  • Rick Friedman, U.S. FDA
  • Marc Glogovsky, ValSource, Inc.
  • Andy Hopkins, AbbVie Inc.
  • Mai Huynh, U.S. FDA
  • Al Kentrup, Takeda
  • Patrick Lynch, U.S. FDA
  • Ingrid Markovic, U.S. FDA
  • Ken Nolan, U.S. FDA
  • Erika Pfeiler, U.S. FDA
  • Jackie Veivia-Panter, BioCentriq
  • Lorraine Wood, U.S. FDA

More information coming soon.

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].

Day 1

MONDAY, 09 SEPTEMBER

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

10:00 - 10:45 | Networking Break in the Exhibit Area

10:45 – 12:30 | P2: Center Office Updates

The global regulatory landscape is evolving. How will the U.S. FDA continue to optimize its strategies and actions to accomplish its mission to safeguard the quality, safety, and effectiveness of medicines for patients, even with current manufacturing and supply challenges? After introductory presentations on current Center activities, your questions will be posed to executive management from various FDA Centers! In a roundtable format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space.

10:45 | CBER Updates

11:00 | CDER Updates

11:15 | CVM Updates

11:30 | ORA Updates

11:45 | Q&A

12:30 - 14:00 | Lunch on Own

14:00 - 15:30 | Concurrent Sessions

A1: Proactive vs. Reactive Compliance and Addressing Symptoms Signals Early

B1: Updates in Pharmaceutical CGMP Guidance and Policy

C1: Selecting a Supplier: Manufacturing Performance and Data Integrity

15:30 – 16:15 | Networking Break in the Exhibit Area

16:15 - 17:45 | Concurrent Sessions

A2: CGMP and Data Integrity: Identifying and Filling the Gaps

B2: Sterile Manufacturing Facilities and Quality Risk Management: Current Issues and Solutions

C2: Review of Notable Investigations and Recalls

19:00 – 22:00 | Grand Opening Reception

Day 2

TUESDAY, 10 SEPTEMBER

07:15 - 08:15 | Breakfast Sessions

Breakfast 1: Effective Quality Systems

Breakfast 2: Microbiology

Breakfast 3: Disaster Recovery Planning

Breakfast 4: Dealing with Particulates in ATMPs

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

Featuring Office of Compliance leaders from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. In a roundtable format, FDA's top leaders in compliance and enforcement will describe their programs, initiatives, and recent actions related to inspections and compliance. Current regulatory challenges and FDA's current enforcement strategy for a wide array of medical products will be addressed. This is a great opportunity for you to understand FDA's thinking and expectations for industry compliance. In addition, there will be ample time for the audience to ask questions of FDA's senior leadership.

08:30 | CBER Compliance Updates

08:45 | CDER Compliance Updates

09:00 | CVM Compliance Updates

09:15 | ORA Compliance Updates

09:30 | Q&A

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

11:00 - 12:30 | Concurrent Sessions

A3: Strategic Communication: A Blueprint for Preventing Aging Facility Pitfalls

B3: Quality Enabling Behaviors

C3: Cybersecurity Hygiene in Pharma: Lessons from the Digital Battlegrounds

12:30 – 14:00 | Lunch on Own

14:00 - 15:30 | Concurrent Sessions

A4: The Importance of Independence and Authority for the Quality Unit

B4: CGMP Considerations for Implementation of Emerging Technologies: Modeling for Control Strategy and Process Validation

C4: De-Risking Your Quality Control Laboratory

15:30 – 16:15 | Networking Break and Passport Drawing in the Exhibit Area

16:15 - 17:45 | Concurrent Sessions

A5: Expanding Quality Ownership Beyond the Quality Department: How to Engrain It Across the Organization

B5: Innovations in GMP Compliance: Regulatory Perspectives on Embracing Digital Technologies

C5: Improving Auditing Programs: Going Beyond a Checkbox Approach

Day 3

WEDNESDAY, 11 SEPTEMBER

07:15 - 08:15 | Breakfast Sessions

Breakfast 5: Platform Technologies Development for ATMPs and Vaccines: GMP and CMC Considerations

Breakfast 6: AI in the GMP Space

Breakfast 7: X-Ray Technology

08:30 – 10:00 | P4: Current GMP Compliance Trends and Topics

This "can't miss" session will include presentations from CDER and CBER and will provide more than just the "Top Ten 483 observations." Participants will gain an understanding of the most recent trends from violative inspections and enforcement actions. This session routinely provides several key topics for attendees to consider and take back for discussion with their team members and colleagues.

08:30 | CDER Updates

08:55 | CBER Updates

09:20 | Q&A

10:00 – 10:30 | Networking Break

10:30 – 12:00 | P5: Operationalizing Quality Risk Management and Knowledge Management

12:15 – 13:15 | Lunch with the Regulators

Bring questions for U.S. FDA investigators, reviewers, and compliance officers to this lunch Q&A session that will allow for direct input and will provide you with insights regarding inspection trends and center initiatives.

13:30 - 15:00 | P6: Closing Plenary

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.

The Westin, DC Downtown

999 9th Street, NW
Washington, DC 20001, United States

+1 (202) 898-9000

Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.

Discover the vibrant heart of the city at the new Westin Washington, DC Downtown—an energizing gathering place bursting with fresh ideas. Immerse yourself in the allure of iconic experiences, just steps away from the family-friendly hotel in Washington, D.C.. From the National Mall to Chinatown, Capital One Arena to CityCenterDC, the best of the city awaits outside our doors. Unwind in our inviting guest rooms, featuring the renowned Heavenly® Bed. Ignite your passion in our expansive 10,000 sq. ft. fitness center, the largest in Washington, D.C. Indulge in locally sourced culinary delights that will invigorate your senses. With over 70,000 sq. ft. of flexible meeting space, including a 19,000 sq. ft. grand ballroom, we cater to a variety of gatherings. Our complete transformation has given rise to inspiring spaces, where Westin guests thrive, finding productivity and rejuvenation in perfect harmony.

Rate: $331 plus applicable taxes and fees
Reservation Link:
Reservation Phone:
Cut-Off: Friday, 09 August 2024

How to Get Here
By Air The three airports closest to the Westin, DC Downtown are Ronald Reagan Washington National Airport (DCA - approx. 5 miles/8 km), the Washington Dulles International Airport (IAD - approx. 28 miles/45 km)