PDA FDA 2024

PDA/FDA Joint Regulatory Conference 2024

Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity

09 - 11 September 2024
Westin Washington, DC Downtown
Washington, DC

Educational Sessions | Interest Groups | Networking Opportunities | Exhibit Area

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  • Milind Ganjawala MS, MBA

    U.S. FDA

    Division Director, DDQ2, OMQ, OC, CDER

    Read Bio
  • Janeen Skutnik-Wilkinson

    Moderna, Inc.

    Director, Global Quality, Regulatory Surveillance & External Engagement

    Read Bio

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Amplify Your Presence and Reach Your Customers!

Become a supporter and/or exhibitor at the only co-sponsored pharmaceutical Current Good Manufacturing Practice (CGMP) conference offered in the United States. As a supporter and/or exhibitor, you'll have unparalleled opportunities to connect with industry leaders, showcase your products and services, and establish your company as a part of the industry.

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Schedule

Discover What's Happening Each Day
PDA/FDA Day 109 Sep PDA/FDA Day 210 Sep PDA/FDA Day 311 Sep PDA Workshop11-12 Sep PDA Training12-13 Sep

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

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

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

Location and Travel

Venue Details and Accommodations

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.

Conference Venue & Hotel Accommodations

Cancellation Policy
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.
The Westin Washington DC

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 hotel in Washington, DC. From the National Mall to Chinatown, Capital One Arena to the CityCenterDC outdoor shopping area, the best of the city awaits outside the doors. Unwind in inviting guest rooms, featuring the renowned Heavenly® Bed. Ignite your passion in the expansive 10,000 sq. ft. fitness center, the largest in Washington, D.C. Indulge in locally sourced culinary delights that will invigorate your senses. The hotel’s 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 (currently 15.95%)
Cut-Off Date: Friday, 09 August 2024
How to Get Here
By Air The Westin Washington, DC Downtown is accessible from three major airports: Ronald Reagan Washington National Airport (DCA - approx. 5 miles/8 km), the Washington Dulles International Airport (IAD - approx. 28 miles/45 km), and the Baltimore/Washington International Thurgood Marshall Airport (BWI - approx. 34 miles/55 km).
By Car The Westin Washington, DC Downtown is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($48+/day) and valet parking ($65+/day) are available.
By Other Options The Westin Washington, DC Downtown is easily accessible from the following Metro stops: Gallery Place-Chinatown (Green, Red, and Yellow Lines, 7th St. & H St., NW exit - approx. 0.2 miles/0.3 km) and Metro Center (Blue, Orange, Red, and Silver Lines, 11th St. and G St., NW exit - approx. 0.4 miles/0.6 km).

Registration

Pricing Options

Early Registration

Register by 17 July 2024

Member Price

$2,395

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$2,795

Standard Registration

Register after 17 July 2024

Member Price

$2,895

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$3,295

Livestream Registration

Livestream Details

Member Price

$2,395

GovernmentMember Only

$895

Health AuthorityMember Only

$895

Early Career ProfessionalMember Only

$1,395

StudentMember Only

$595

AcademicMember Only

$895

Non-Member

$2,795

See Qualifying Criteria for Member Types.

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 registration@pda.org.


 

Activities and Networking Opportunities

Connect and Collaborate
Tuesday, 10 September 2024

Monuments by Moonlight Trolley Tour

See DC’s most popular monuments in a different light! On the Monuments by Moonlight Trolley Tour, be transported to many of the city’s most famous sights while enjoying the tranquil night and evening breeze.

Date and time

Tuesday, 10 September / 18:45 – 21:00 ET

Cost

$52 per person, includes private trolley tour and professional live tour guide.

Limit

35 people Max.

About this tour

See DC’s most popular monuments in a different light! On the Monuments by Moonlight Trolley Tour, be transported to many of the city’s most famous sights while enjoying the tranquil night and evening breeze. Along the way, a professional tour guide will take you back in time as they share historic tales and anecdotes about the city’s fascinating history. Learn about the curse of the Hope Diamond and its legacy of death and despair and hear about the Medal of Honor winner who donated his amputated leg to a museum (and often visited it!). You haven’t seen DC until you’ve seen it at night!

Monuments include the Franklin Delano Roosevelt Memorial, the Korean War Veterans Memorial, the Lincoln Memorial, the Marine Corps War Memorial, the Martin Luther King, Jr. Memorial, the Thomas Jefferson Memorial, the United States Capitol, the Vietnam Veterans Memorial, and the Washington Monument.

Timeline
  • 18:45 Tour participants meet PDA staff in Westin Washington, DC Downtown lobby
  • 19:00 Tour departs from Westin Washington, DC Downtown
  • 21:00 Tour returns to Westin Washington, DC Downtown

Program Planning Committee

The Team Behind the Event's Agenda
  • Denyse D. Baker, PE, RAC

    Eli Lilly and Company

    Associate Vice President, External Engagement and Advocacy, Global Quality Compliance

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  • Paul Z. Balcer

    U.S. FDA

    Program Manager, OMQ, OC, CDER

    Read Bio
  • Tara Gooen Bizjak, MBS

    U.S. FDA

    Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER

    Read Bio
  • Francesco Cicirello, PharmD, MSc

    BioNTech

    Senior Director Quality Compliance

    Read Bio
  • Daniel DeCiero

    U.S. FDA

    Consumer Safety Officer, OCBQ, CBER

    Read Bio
  • Nicole Deschamps, PhD

    GSK

    Senior Director, External Development Operations and Process Excellence

    Read Bio
  • Rebecca E. Dowd, MS

    U.S. FDA

    Director, Investigations Branch, Division 3, OPQO, ORA

    Read Bio
  • Mary E. Farbman, PhD

    Merck & Co., Inc.

    Associate Vice President, Global Quality Compliance

    Read Bio
  • Irving Ford, MSc

    Adaptimmune

    VP of Quality

    Read Bio
  • Rick L. Friedman, MS

    U.S. FDA

    Deputy Director, OMQ, OC, CDER

    Read Bio
  • Marc Glogovsky, MS

    ValSource, Inc.

    Business Unit Manager - Microbiology

    Read Bio
  • Andrew D. Hopkins, PGDip

    AbbVie Inc.

    Director, Operation Quality QA Audit and Compliance

    Read Bio
  • Mai X. Huynh, MS

    U.S. FDA

    Supervisory Chemist, ONADE, CVM

    Read Bio
  • Al Kentrup

    Consultant

  • Patrick J. Lynch, PhD

    U.S. FDA

    Division Director, OPQ, CDER

  • Ingrid Markovic, PhD

    U.S. FDA

    Senior Science Advisor, Office of the Center Director, ORO, CBER

    Read Bio
  • Erika A. Pfeiler, PhD

    U.S. FDA

    Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER

    Read Bio
  • Jackie Veivia-Panter

    Consultant

    Read Bio
  • Photo coming soon

    Kenneth Nolan

    U.S. FDA

    Senior Advisor

  • Photo coming soon

    Lorraine D. Wood, MS

    U.S. FDA

    Health Science Project Manager

Supporters

Supporters and Collaborators
  • Diamond
  • Silver

Exhibitors

Exhibitors and Innovators