PDA/FDA Joint Regulatory Conference 2024
Current Good Manufacturing Practice (CGMP): Leading with Quality and Integrity
Educational Sessions | Interest Groups | Networking Opportunities | Exhibit Area
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Registration Options
Individual Registration
Livestream Registration
Group Registration
Benefit from the Only Co-Sponsored Pharmaceutical Drug CGMP Conference Offered in the United States
Gain in-depth knowledge, practical understanding and real-world experiences via sessions, discussions and case studies demonstrating how CGMP establishes the foundation for drug product quality.
Current Good Manufacturing Practice (CGMP) assures the safety and efficacy of drug products and ultimately protect patients.
Become a Supporter
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.
Become a SupporterSchedule
Discover What's Happening Each Day
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
PDA GMP Comparison Workshop 2024
11 Sep - 12 Sep
PDA 529 Technical Report No. 54: Foundations of Quality Risk Management
TBAPDA 374 Technical Report No. 22: Process Simulation for Aseptically Filled Products
12 SepPDA 279 Biotechnology: Overview of Principles, Tools, Processes and Products
12 Sep - 13 SepPDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making
TBAPDA 576 Root Cause Investigation for CAPA
TBA
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
Westin Washington, DC
999 9th Street, NWWashington, DC 20001, United States
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 feesCut-Off: Friday, 09 August 2024
How to Get Here
By Air
The two 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)
Registration
Pricing Options
Early Registration
Register by 17 July 2024
Member Price
$2,395GovernmentMember 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
$2,895GovernmentMember Only
$995
Health AuthorityMember Only
$995
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$995
Non-Member
$3,295
Livestream Registration
Member Price
$2,395GovernmentMember Only
$895
Health AuthorityMember Only
$895
Early Career ProfessionalMember Only
$1,395
StudentMember Only
$595
AcademicMember Only
$895
Non-Member
$2,795
Activities and Networking Opportunities
Connect and Collaborate
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 event
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 hotel lobby
- 19:00 Tour departs from Westin hotel
- 21:00 Tour returns to Westin hotel
Program Planning Committee
The Team Behind the Event's Agenda
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Denyse Baker PE, RAC
Eli Lilly and Company
Associate Vice President, External Engagement and Advocacy, Global Quality Compliance
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Nicole Deschamps PhD
GSK
Senior Director, External Development Operations and Process Excellence
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Tara Gooen Bizjak MBS
U.S. FDA
Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
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