PDA Regulatory Conference 2025
Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle
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Benefit from the premier pharmaceutical CGMP conference in Washington, DC
Gain in-depth knowledge and practical insight through focused sessions, interactive discussions, case studies, and regulatory updates from U.S. FDA regulators – all designed to help you apply Current Good Manufacturing Practice (CGMP) principles with confidence and precision.
Returning to Washington, DC for the 34th year, PDA’s annual September regulatory conference continues to serve as the industry’s most trusted forum for open, informed dialogue between global regulators and pharmaceutical professionals.
The PDA Regulatory Conference 2025 builds on this legacy, delivering impactful content that advances the development and implementation of effective quality systems across the product lifecycle. Sessions will explore proven strategies for managing manufacturing and quality risks while driving operational excellence and sustainable compliance.
With strong U.S. FDA participation woven throughout the program, the Conference will spotlight the critical role of robust quality systems, facility and process design, supplier and raw material oversight, industrial modernization, and quality risk management as essential pillars of CGMP commpliance.
Case studies – many shaped by regulator insights – will showcase real-world applications of sustainable compliance that lead to consistent product quality and reliable supply.
This year more than ever, don't miss your opportunity to engage directly with regulators and industry leaders at the event designed to inform, educate, and guide you through today's most pressing regulatory challenges.
In addition to the Regulatory Conference, PDA is offering a variety of workshops and training courses on Thursday and Friday (11-12 Sep) – giving attendees the opportunity to deepen their learning through practical, hands-on application.
- PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop 2025
- Aseptic Processing Essentials Workshop
- CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course
- Contamination Control Strategy Essentials Workshop
- Decision-Making in Pharma Manufacturing: Ethics, Compliance, and Resilience Training Course
- Fundamentals of Quality Risk Management Training Course
- GxP Auditing Logistics and Inspection Readiness Training Course (Including Mock Activity)
- Measuring Quality Culture using PDA's Assessment Tool Training Course
- Quality and Compliance Management for Virtual Companies Training Course
The PDA Regulatory Conference 2025 remains your trusted source for CGMP insights. Registration is now open with early pricing!
Agenda
Discover What's Happening Each Day
14:00 – 19:00 | Registration Open
15:00 – 18:00 | Presenter Ready Room Open
16:00 – 17:30 | PDA Roundtable: FDA Complete Response Letters: A Growing Industry Challenge with Big Impacts (Ticket Required) In recent years, the industry has seen a sharp rise in FDA Complete Response Letters (CRLs) tied to manufacturing and facility related issues—letters that can delay approvals, disrupt supply chains, and impact patient access. This session will examine the increased frequency and significance of these CRLs, providing a timely overview of the challenges they present and the implications for regulatory strategy and operational readiness. Attendees will gain insight into PDA’s ongoing efforts to analyze and understand the underlying issues causing the CRL trends and recommended actions being proposed to reduce the trend. The session will feature perspectives from PDA leadership, legal experts, and regulatory affairs professionals, and will conclude with an interactive discussion on next steps for industry action. All roundtable registration fees will be donated to the PDA Foundation’s Jette Christensen Memorial Early Career Professional Fund, supporting the next generation of pharma leaders. Learn more |
16:00 | Welcome and Introductory Remarks 16:05 | CRL Recap 16:20 | CRL Impacts and Current Issues 16:50 | Q&A with Additional Panelist 17:20 | Closing Remarks |
MONDAY, 08 SEPTEMBER
07:00 – 19:00 | Registration Open
07:00 – 08:30 | Continental Breakfast
07:00 – 16:15 | Presenter Ready Room Open
08:30 – 10:00 | P1: Quality in Advanced Therapies and Global Collaboration This opening plenary will explore how quality assurance and sustainable compliance drive innovation in advanced therapies. A senior industry leader and a patient advocate will offer powerful perspectives on how quality systems enable global collaboration, manufacturing evolution, and public trust. Together, these voices will illustrate both the operational and human impact of quality in a rapidly shifting therapeutic landscape. |
08:30 | Welcome and Opening Remarks 08:50 | The Power of Quality 09:10 | The Human Impact 09:30 | Q&A |
10:00 – 11:00 | Networking Break in the Exhibit Area
11:00 – 12:30 | P2: Current GMP Compliance Trends and Topics What are the most common GMP compliance challenges facing the industry today—and what can we learn from them? This session will examine recent inspection trends, 483 observations, and enforcement actions. Attendees will take away practical insights to strengthen quality systems and manage regulatory risks more effectively. |
11:00 | Drug Compliance Trends and Topics 11:25 | Biologics Compliance Trends and Topics 11:50 | Q&A with Additional Panelists |
12:30 – 14:00 | Lunch Break
14:00 – 15:30 | Concurrent Sessions
A1: Competency-Based Training and Digital Learning This session will focus on building skill-based training models that go beyond checkbox compliance. Speakers will explore how organizations are aligning training with real-world performance and leveraging digital tools to deliver more relevant, responsive learning. |
14:00 | Building Quality Through Competency-Based Training 14:25 | Innovative Approaches to CGMP Education and Workforce Development 14:50 | Q&A |
B1: Data Integrity As data systems grow more complex, maintaining integrity becomes more critical—and more challenging. This session will examine today’s data governance realities, including the root causes of DI failures and what regulators are looking for during inspections. |
14:00 | DI: The Unbreakable Chain – Is Yours Strong Enough? 14:25 | DI Under Scrutiny: Strategies for Sustainable Compliance 14:50 | Q&A |
C1: Contractor and Supplier Oversight Strong quality oversight doesn’t end at your facility's walls. This session will highlight how companies are strengthening compliance through robust quality agreements, risk-based oversight, and clearer roles and responsibilities in outsourced operations. |
14:00 | Ensuring CGMP Compliance in Contract Manufacturing 14:25 | Defining Roles and Responsibilities in Quality Agreements 14:50 | Q&A |
15:30 – 16:30 | Networking Break in the Exhibit Area
16:30 – 18:00 | Concurrent Sessions
A2: Leveraging AI in Audits This session will explore how artificial intelligence (AI) is being integrated into internal audit programs to identify risks faster, improve coverage, and focus human efforts where they matter most. Speakers will discuss both the potential and the practical limitations of these tools. |
16:30 | Quality Oversight in the Age of Data Integrity and AI 16:55 | Digitalization and the Evolving Role of Quality Oversight 17:20 | Q&A |
B2: Mastering Visual Inspection Visual inspection (VI) may be a legacy process, but innovation hasn't stopped. This session will examine new approaches, automation technologies, and evolving expectations for particulate control in both manual and automated settings. |
16:30 | Modernizing VI: Trends and Tactics for Success 16:55 | Advancing Inspection Technologies Through Deep Learning and Automation 17:20 | Q&A |
C2: Crisis Management and Resilience When disruption strikes, quality leaders must respond with clarity and speed. This session will feature strategies and case studies in contingency planning, cross-functional coordination, and maintaining GMP control under pressure. |
16:30 | Proactive Operational Compliance: Strengthening Site Preparedness and Resilience 16:55 | Crisis Management Partnerships: Ensuring Quality Through Disruption 17:20 | Q&A |
18:00 – 20:00 | Networking Reception
TUESDAY, 09 SEPTEMBER
07:00 – 18:00 | Registration Open
07:00 – 08:30 | Continental Breakfast
07:00 – 16:45 | Presenter Ready Room Open
07:15 – 08:15 | Concurrent Breakfast Sessions
Breakfast 1: Fundamentals of CGMPs Designed for newer professionals and cross-functional attendees, this session will offer a practical overview of Current Good Manufacturing Practices (CGMPs) and their application across the product lifecycle. |
07:15 | CGMPs Made Practical: A Guide for New and Non-Compliance Professionals 07:40 | Q&A |
Breakfast 2: Knowledge Sharing Best Practices This session will focus on how to create effective knowledge-sharing systems within regulated environments—highlighting approaches that support learning, consistency, and performance across teams and sites. |
07:15 | Turning Information Into Impact 07:40 | Q&A |
Breakfast 3: Using Digital Technologies to Assess and Ensure Compliance From audit preparation to ongoing monitoring, this session will show how digital tools are being used to streamline compliance activities, surface risk signals, and support proactive quality oversight. |
07:15 | Strengthening Compliance with Smarter Systems 07:40 | Q&A |
08:30 – 10:00 | P3: Data Integrity at the Next Level With digital systems advancing rapidly, traditional approaches to data integrity need a rethink. This session will explore how modern manufacturing environments are addressing data governance, mistake-proofing, and evolving expectations for compliance in a tech-enabled world. |
08:30 | Advancing DI: New Challenges, Practical Solutions 08:55 | Building Resilient Data Systems: Governance and Good Practice 09:20 | Q&A |
10:00 – 11:00 | Networking Break in the Exhibit Area
11:00 – 12:30 | Concurrent Sessions
A3: Innovation in Validation and Manufacturing New products and technologies demand new validation strategies. This session will spotlight how teams are rethinking process validation (PV) and GMP alignment for high-risk or emerging modalities, all while staying inspection-ready. |
11:00 | PV in Motion: Enabling Concurrent Release 11:25 | Phase-Appropriate Approaches for ATMPs: GMP, CMC, and PV 11:50 | Q&A |
B3: Metrics and Sustainable Compliance Metrics can do more than track performance—they can shape it. This session will explore how meaningful metrics are being used to influence behavior, drive decision-making, and embed long-term compliance into daily operations. |
11:00 | Making Metrics Work: A Practical Framework for Compliance Monitoring 11:25 | Sustainable Compliance 11:50 | Q&A |
C3: Quality Oversight in a Digitized Supply Chain As supply chains grow more complex and interconnected, digital oversight becomes essential. This session will explore how organizations are using lab systems, supplier dashboards, and real-time data to manage quality beyond their own walls. |
11:00 | QC Laboratory Issues 11:25 | Supply Chain Surveillance Dashboards 11:50 | Q&A |
12:45 – 13:45 | Lunch with the Experts
14:00 – 15:30 | Concurrent Sessions
A4: Innovations in Facility and Technology Strategy As facilities evolve to meet the demands of modern manufacturing, so must the strategies that support them. This session will look at how physical upgrades and digital systems are being integrated to elevate GMP performance, reduce compliance risk, and enable smarter, more agile operations. |
14:00 | Upgraded Facilities to Assure Quality and Compliance 14:25 | Digitization for In-House Operational Excellence 14:50 | Q&A |
B4: How to Make Quality Culture Real What does quality culture actually look like in practice? This session will focus on turning an abstract ideal into daily behaviors and systems. From onboarding to audits, presenters will examine how organizations are embedding quality expectations into every level of work—making “quality ownership” real, measurable, and lasting. |
14:00 | The Q Also Applies to U 14:25 | A Commonsense Approach to Compliance 14:50 | Q&A |
C4: Supply Chain Risk and Resilience Disruption is inevitable—how you prepare makes the difference. This session will highlight approaches to identifying supply chain vulnerabilities before they lead to failure. Through case studies and modeling examples, presenters will show how to build in resilience through risk-based qualification, proactive monitoring, and scenario planning. |
14:00 | Ensuring Supply Chain Integrity: Case Studies in Risk Management 14:25 | Supplier Risk Modeling and Qualification 14:50 | Q&A |
15:30 – 16:30 | Networking Break and Passport Drawing in the Exhibit Area
16:30 – 18:00 | Concurrent Sessions
A5: Inspection Readiness in Practice This session will explore how companies maintain a daily state of readiness for regulatory inspections. From internal audits and systems alignment to facility-level training, presenters will highlight the real-world challenges and solutions that support proactive inspection planning—long before the agency arrives. |
16:30 | AbbVie Inspection-Readiness Program 16:55 | Real-World Lessons in Inspection Preparation 17:20 | Q&A |
B5: Decision-Making and Knowledge Transfer In today’s complex manufacturing environments, quality decisions must be both risk-informed and timely. This session will examine how companies are capturing institutional knowledge and structuring decision-making frameworks that adapt to change without compromising control. |
16:30 | Quality and Knowledge Management 16:55 | Enhancing Decision Making through Quality Systems in a VUCA World 17:20 | Q&A |
C5: Evolving Release Models in a Visual and Digital Era Global expectations for lot release are changing—driven by new technologies, product types, and regional approaches. This session will look at how digital tools, visual inspection (VI) evolution, and shifting global practices are redefining how products move from manufacturing to market. |
16:30 | Reimagining Lot Release for Vaccines: Balancing Speed, Innovation, and Assurance 16:55 | VI in a Changing Manufacturing Landscape 17:20 | Q&A |
18:00 – 21:00 | PDA Capital Area Chapter Reception (Separate Sign-Up Required) More information coming soon! |
19:00 – 21:00 | Lincoln's Last Night Walking Tour ($40 per person) |
WEDNESDAY, 10 SEPTEMBER
07:00 – 15:00 | Registration Open
07:00 – 08:30 | Continental Breakfast
07:00 – 11:00 | Presenter Ready Room Open
07:15 – 08:15 | Concurrent Breakfast Sessions
Breakfast 4: Building a Strong Quality Culture This panel discussion will explore what it takes to create and sustain a meaningful quality culture—one that goes beyond slogans and scorecards. Industry leaders will share insights on aligning behavior, leadership, and systems with a shared vision for quality excellence. |
07:15 | Framing the Conversation 07:25 | Panel Discussion 07:50 | Q&A |
Breakfast 5: Post-Approval Changes and Lifecycle Management This session will highlight how post-approval changes (PACs) fit into broader lifecycle strategy and sustainable compliance. Presenters will discuss practical considerations, regulatory expectations, and how proactive planning supports long-term success. |
07:15 | Managing PACs 07:40 | Q&A |
Breakfast 6: GxP Inspections Around the World: What’s Changing? This session will spotlight recent changes and emerging trends in GxP inspections across global regions. Panelists will provide a snapshot of evolving expectations, inspection harmonization efforts, and what manufacturers should prepare for in today’s international landscape. |
07:15 | Framing the Conversation 07:25 | Panel Discussion 07:50 | Q&A |
08:30 – 10:30 | P4: Agency Updates: Regulatory Priorities and Enforcement Outlook The regulatory environment continues to evolve, with agencies and industry alike adapting to meet new and ongoing challenges. This session will feature updates on current priorities, inspection and enforcement trends, and cross-cutting issues affecting the life sciences sector. Attendees will hear practical insights into how regulatory expectations are shifting—and how organizations can stay ready. |
08:30 | Biologics Updates 08:50 | Drug Updates 09:10 | Veterinary Medicine Updates 09:30 | Inspections and Investigations Updates 09:50 | Q&A |
10:30 – 11:00 | Networking Break
11:00 – 12:15 | P5: Regulatory Updates |
11:00 | Hot Topic Updates 11:25 | Guidance Updates 11:50 | Q&A |
12:30 – 13:30 | Lunch with the Regulators |
13:45 – 15:15 | P6: The “Q” Also Applies to “U” This closing plenary will spotlight the essential role of executive leadership in shaping and sustaining a culture of quality. With a focus on ownership, mindset, and accountability at the highest levels, the session will challenge leaders to lead by example and embed quality across every layer of their organization. Attendees will leave energized and aligned around the idea that quality is not just a function—it’s a shared responsibility that starts at the top. |
13:45 | Driving Quality from the Top: Leadership That Sets the Standard 14:10 | Culture Starts at the Top: A Conversation with Quality Leaders 15:10 | Closing Remarks from the Conference Co-Chairs |
16:00 – 18:30 | PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop 2025 (Day 1 of 2 - Separate Registration Required) Learn by doing! This hands-on workshop delivers practical tools and real-world strategies to help you explore, evaluate, and implement AI solutions that enhance quality, efficiency, and control in your organization. |
THURSDAY, 11 SEPTEMBER
07:00 – 16:45 | Registration Open
08:00 – 16:00 | PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop 2025 (Day 2 of 2 - Separate Registration Required) Learn by doing! This hands-on workshop delivers practical tools and real-world strategies to help you explore, evaluate, and implement AI solutions that enhance quality, efficiency, and control in your organization. |
08:30 – 16:45 | PDA Training and Research Institute Essentials Workshops and Training Courses (Separate Registration Required) |
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FRIDAY, 12 SEPTEMBER
07:30 – 16:00 | Registration Open
08:30 – 16:00 | PDA Training and Research Institute Training Courses (Separate Registration Required) |
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Activities and Networking Opportunities
Connect and Collaborate with Purpose
Lincoln's Last Night Walking Tour
Step into the shadows of history on a walking tour that traces the dramatic and chilling events of one of America's most infamous nights. Led by an expert guide, this immersive experience unpacks the three-pronged conspiracy aimed at decapitating the U.S. government through the coordinated attacks on President Abraham Lincoln, Secretary of State William Seward, and Vice President Andrew Johnson. As you stroll past landmarks like the White House and Lafayette Square, the stage is set for a gripping story of political ambition, betrayal, and tragedy that has captivated the world for more than a century.
Visit the very sites tied to the conspiracy—from Seward’s home, where he narrowly survived a brutal attack, to the Kirkwood House Hotel, connected to the plot against the Vice President. Walk in the footsteps of Lincoln on the night of his assassination, from Ford’s Theatre to Peterson’s Boarding House, where he drew his last breath. Along the way, hear the untold stories of the conspirators’ escape route through Baptist Alley, the failed kidnapping plot that preceded the assassination, and the deeply personal toll on Lincoln’s family. This is more than a tour – it’s a powerful exploration of resilience, history, and the enduring impact of a single night.
Price$40 per person – includes private guided walking tour with professional, live tour guides
Limit50 people max.
Time19:00 – 21:00 EDT
Timeline19:00 Tour departs from Westin lobby
21:00 Tour returns to Westin
A jacket or sweater is recommended as evening temperatures can dip as low as 55°F (13°C)
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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.
The Westin DC Downtown
999 9th Street, NWWashington, DC 20001 USA
+1 800-228-9290
Reservation Instructions
Welcome to the Westin DC Downtown hotel — an energizing gathering place bursting with fresh ideas and the headquarter hotel for the PDA Regulatory Conference 2025. From the National Mall to Chinatown, Capital One Arena to City Center DC, the best of Washington, DC awaits just outside the doors.
- Rate per Night: $339 USD + 15.95% tax (subject to change) + fees
- Cut-Off Date: Friday, 08 August 2025
- Check-In: 16:00 EDT
- Check-Out: 12:00 EDT
- Note: No more than two (2) room reservations may be made under the same guest name. If you are interested in making more than two (2) hotel reservations, please contact the PDA Registration Team to inquire about a sub-block.
Cancellation Policy: All cancellations must be received by 23:59 ET three (3) days before arrival to avoid a penalty of one (1) night's room and tax.
How to Get Here
Area Attractions
- National Museum of Women in the Arts (approx. 0.3 mile/0.5 km)
- National Portrait Gallery (approx. 0.3 mile/0.5 km)
- Planet Word (approx. 0.3 mile/0.5 km)
- Ford's Theatre (approx. 0.5 mile/0.8 km)
- National Building Museum (approx. 0.5 mile/0.8 km)
Registration
Pricing Options
Early Registration
Register by 05 August 2025
Member Price
$2,395GovernmentMember Only
$695
Early Career ProfessionalMember Only
$1,395
StudentMember Only
$595
AcademicMember Only
$695
Non-Member
$2,795
Standard Registration
Register after 05 August 2025
Member Price
$2,895GovernmentMember Only
$895
Early Career ProfessionalMember Only
$1,495
StudentMember Only
$695
AcademicMember Only
$895
Non-Member
$3,295
Tuesday Evening Walking Tour
$40 per person
Tuesday, 09 September
19:00-21:00 EDT
50 tickets available
Includes private guided walking tour with professional, live tour guides
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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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Boost your brand and visibility by becoming an exhibitor at the PDA Regulatory Conference 2025! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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