PDA Regulatory Conference 2025

Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle

07 - 12 Sep 2025
Washington, DC

Networking Opportunities | Exhibit Area | Hot Topic Roundtable
Interest Groups | Educational Sessions | Training Courses and Workshops

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Get the regulatory clarity you need at the industry's most trusted CGMP conference

Gain actionable insights through focused sessions, interactive discussions, real-world case studies, and the latest 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 remains the pharmaceutical industry’s most trusted forum for open, informed dialogue between global regulators and pharmaceutical professionals.

The PDA Regulatory Conference 2025 builds on this legacy with a robust agenda focused on advancing 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 critical CGMP pillars–including quality systems, facility and process design, supplier oversight, industrial modernization, and quality risk management. Real-world case studies–many shaped by regulator insights–will demonstrate how sustainable compliance translates into consistent product quality and a reliable supply chain.

Now more than ever, don’t miss your chance to engage directly with regulators and peers, gain practical tools, and stay ahead of evolving expectations at the industry’s leading regulatory event.

Immediately following the Conference, PDA will offer a suite of in-depth workshops and training courses (11-12 Sep) to extend your learning through hands-on application:

Registration is now open–secure your spot today and take advantage of early pricing!

Agenda

Discover What's Happening Each Day
Download Full Schedule Please note that this file may take some time to download depending on your internet connection. Thank you for your patience.
Agenda is subject to change. *
Sun 07 Sep Mon 08 Sep Tue 09 Sep Wed 10 Sep Thu 11 Sep Fri 12 Sep
Sunday, 7 September

EDT Daylight Time (UTC -4:00)

Monday, 8 September

EDT Daylight Time (UTC -4:00)

Tuesday, 9 September

EDT Daylight Time (UTC -4:00)

  • Continental Breakfast

  • Presenter Ready Room Open

  • Registration Open

  • Breakfast 1: Fundamentals of Current Good Manufacturing Practices

    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.

    • CGMPs Made Practical: A Guide for New and Non-Compliance Professionals

    • 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.

    • Turning Information Into Impact

    • 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.

    • Strengthening Compliance with Smarter Systems

    • Q&A

  • IG1: Quality Systems

  • IG2: Regulatory Affairs

  • 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.

    • Advancing DI: New Challenges, Practical Solutions

    • Building Resilient Data Systems: Governance and Good Practice

    • Q&A

  • Networking Break in the Exhibit Area

  • A3: Effective Validation and Manufacturing Strategies

    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.

    • PV in Motion: Enabling Concurrent Release

    • Phase-Appropriate Approaches for ATMPs: GMP, CMC, and PV

    • Q&A

  • B3: Quality Indicators 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.

    • Making Metrics Work: A Practical Framework for Compliance Monitoring

    • Sustainable Compliance

    • Q&A

  • C3: Quality Oversight in a Modern Supply Chain

    In today’s world of increasingly complex supply chains—with many of the activities contracted to third party suppliers, manufacturers, and testing houses—the owner of the registration still retains the responsibility for product safety, quality, and efficacy. Even if they do not perform the activities they can delegate the activity but not the responsibility. It is therefore essential that there are mechanisms for maintaining oversight of the end-to-end process. This session will look at how these responsibilities can be upheld using digitalized systems to pull and filter data into meaningful data sets that can be used as real time and lagging indicators of product safety and compliance. The session will also consider how Artificial Intelligence (AI) may be used in these key activities. The session will give a regulatory and an industry perspective with case studies of systems that are already in place and also what the future may look like.

  • Lunch on Your Own

  • A4: Innovations in Facilities and Technology

    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.

    • Upgraded Facilities to Assure Quality and Compliance

    • Digitization for In-House Operational Excellence

    • Q&A

  • B4: How to Make Quality Culture Real

    Are you growing weary of hearing, “That falls under Quality’s responsibility.”? Achieving a true cultural shift around quality requires engagement from every level of the organization – from frontline employees to executive leadership. This session will present transformational strategies designed to instill a quality-focused mindset across all roles and departments. Participants will learn how to build a culture where quality is not just a department, but a shared commitment by everyone in the organization. A culture that will transform your entire organization into a high performing team where quality is consistently “priority one.”

  • 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.

    • Ensuring Supply Chain Integrity: Case Studies in Risk Management

    • Supplier Risk Modeling and Qualification

    • Q&A

  • Networking Break in the Exhibit Area

  • A5: Inspection Readiness in Practice

    Preparing for an FDA inspection—especially a pre-approval or pre-licensing inspection—requires more than last-minute checklists. Sustained inspection readiness must be built into the fabric of a site’s operations. This session will explore proactive, facility-wide strategies for maintaining a state of continuous readiness. Speakers will share practical steps organizations can take to prepare effectively before the FDA arrives, along with best practices for building a compliance-first mindset across teams. Attendees will also hear directly from FDA on current expectations and trends in recent PAI/PLI inspections. Whether you’re preparing for your first inspection or strengthening an established program, this session offers timely insight from both industry and agency perspectives.

  • 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.

  • C5: Evolving Release Models

    Lot release processes were designed for a different era—longer timelines, centralized manufacturing, and fewer product types. Today’s accelerated vaccine and biologics production demands faster, more flexible approaches. This session will examine evolving models, from parametric and alternative release testing to real-time and just-in-time strategies, one-day disposition, and decentralized networks. The presenters will explore how to balance assurance with speed while adapting to new modalities and global supply chains.

    • Reimagining Lot Release for Vaccines: Balancing Speed, Innovation, and Assurance

    • From Parametric to Predictive: Paving the Way for Real-Time Lot Release

    • Q&A

  • Lincoln's Last Night Walking Tour (Ticket Required)

    Learn More
Wednesday, 10 September

EDT Daylight Time (UTC -4:00)

Thursday, 11 September

EDT Daylight Time (UTC -4:00)

  • 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.
    Register Today

  • Aseptic Processing Essentials Workshop (Separate Registration Required)

    The objective of aseptic processing is to prevent the microbiological contamination of sterile product manufactured using the process. The verification of the ability of the process to produce sterile product is evaluated by aseptic process simulation studies or media fills.

    This essentials workshop is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. The training course will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration, and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

    Participants will also receive a free copy of PDA Technical Report No. 22: Process Simulation for Aseptically Filled Products.

    Workshop Information and Registration

  • CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course (Day 1 of 2, Separate Registration Required)

    Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy encompasses those activities that a manufacturer is required/expected to be carried out by a regulatory authority to protect the patient from the manufactured drug product. Such activities involve Genetic Development, Process Development, Analytical Development Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs. The coordination and timely completion of all the activities by all these CMC groups is necessary for entering clinical development and for continuing to eventually obtain market approval. CMC teams have varying degrees of experience and may not fully appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for the diverse group of biopharmaceuticals – both those that are protein-based (recombinant proteins, monoclonal antibodies, bispecific antibodies, Fc fusion proteins, Fab fragments, and antibody-drug conjugates (ADCs), as well as biosimilars) and those that are nucleic acid-based (viral and non-viral gene therapy vectors, genetically modified patient cells). Examples of CMC strategies that worked and those that did not work will be discussed.

    This training course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory compliant strategy for the manufacture and control of biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The training course emphasis will include CMC regulatory guidance (FDA, EMA and ICH), as well as real-world case examples illustrating CMC regulatory compliance delays in advancing clinical development and blocking market approval.

    Training Course Information and Registration

  • Contamination Control Strategy Essentials Workshop (Separate Registration Required)

    A comprehensive contamination control strategy (CCS) transcends a mere compliance document. A CCS embodies a suite of contamination control principals integral to a company’s all-encompassing approach to managing, mitigating, and assessing contamination risks. The efficacy of each CCS component is closely tied to the collective performance, with the overall success of the CCS hinging on the cooperation of its parts to minimize contamination threats in each process. A well-implemented CCS serves as a conduit for knowledge sharing and continuous improvement.

    This workshop will dive into the practical application of CCS development, moving beyond theory to develop the essential skills for creating a comprehensive CCS. These strategies encompass every facet of production, from facility layout and utilities to environmental management, validation, monitoring, quality systems, personnel, and operational processes.

    Participants of this workshop will receive a complimentary copy of the PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR 90), a valuable resource for workshop preparation. This interactive workshop is your gateway to understanding CCS and its implementation in your manufacturing settings — a hands-on guide to formulating and executing an effective CCS.

    Workshop Information and Registration

  • GxP Auditing Logistics and Inspection Readiness Training Course (Including Mock Activity) (Day 1 of 2, Separate Registration Required)

    Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy encompasses those activities that a manufacturer is required/expected to be carried out by a regulatory authority to protect the patient from the manufactured drug product. Such activities involve Genetic Development, Process Development, Analytical Development Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs. The coordination and timely completion of all the activities by all these CMC groups is necessary for entering clinical development and for continuing to eventually obtain market approval. CMC teams have varying degrees of experience and may not fully appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for the diverse group of biopharmaceuticals – both those that are protein-based (recombinant proteins, monoclonal antibodies, bispecific antibodies, Fc fusion proteins, Fab fragments, and antibody-drug conjugates (ADCs), as well as biosimilars) and those that are nucleic acid-based (viral and non-viral gene therapy vectors, genetically modified patient cells). Examples of CMC strategies that worked and those that did not work will be discussed.

    This training course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory compliant strategy for the manufacture and control of biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The training course emphasis will include CMC regulatory guidance (FDA, EMA and ICH), as well as real-world case examples illustrating CMC regulatory compliance delays in advancing clinical development and blocking market approval.

    Training Course Information and Registration

  • Measuring Quality Culture using PDA's Assessment Tool Training Course (Separate Registration Required)

    Make sure your company stays ahead of the curve! Prepare for this reporting on quality culture with PDA’s comprehensive Quality Culture Assessment Tool, designed to guide your company to a better understanding of quality culture, how to assess it, and what actions to take to improve it.

    In this training course, you will learn how to use this tool to effectively collect verifiable data. As a result, the tool will allow you to facilitate positive culture changes and continuous improvement within your organization.

    The goal is to ensure that a quality mindset and behaviors are embedded into the daily work of the individuals involved in all functions to ultimately ensure the delivery of high-quality products to patients.

    Training Course Information and Registration

  • Quality and Compliance Management for Virtual Companies Training Course (Day 1 of 2, Separate Registration Required)

    Many biotech companies and some pharma companies today are small, “virtual” organizations that outsource most GxP-governed activities such as clinical trials, manufacturing, packaging, laboratory testing, and drug safety monitoring. Such companies often lack in-house knowledge of GCP, GLP and GMP requirements, or have such knowledge vested in very few people. The prospect of an FDA inspection can be a daunting one, as can ensuring that your vendors will pass FDA scrutiny.

    This training course will help you understand what you need to have in place, what the high-risk areas are, and how best to manage those risks as you grow and bring activities in-house. This training course explains the GMP, GCP and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities.

    Training Course Information and Registration

  • Fundamentals of Quality Risk Management Training Course (Separate Registration Required)

    This training course will provide an overview of the Quality Risk Management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.

    This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision-making in using a risk register and a best practice approach for building a QRM program at your company.

    Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

    Training Course Information and Registration
Friday, 12 September

EDT Daylight Time (UTC -4:00)

  • CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course (Day 2 of 2, Separate Registration Required)

    Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy encompasses those activities that a manufacturer is required/expected to be carried out by a regulatory authority to protect the patient from the manufactured drug product. Such activities involve Genetic Development, Process Development, Analytical Development Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs. The coordination and timely completion of all the activities by all these CMC groups is necessary for entering clinical development and for continuing to eventually obtain market approval. CMC teams have varying degrees of experience and may not fully appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for the diverse group of biopharmaceuticals – both those that are protein-based (recombinant proteins, monoclonal antibodies, bispecific antibodies, Fc fusion proteins, Fab fragments, and antibody-drug conjugates (ADCs), as well as biosimilars) and those that are nucleic acid-based (viral and non-viral gene therapy vectors, genetically modified patient cells). Examples of CMC strategies that worked and those that did not work will be discussed.

    This training course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory compliant strategy for the manufacture and control of biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The training course emphasis will include CMC regulatory guidance (FDA, EMA and ICH), as well as real-world case examples illustrating CMC regulatory compliance delays in advancing clinical development and blocking market approval.

    Training Course Information and Registration

  • GxP Auditing Logistics and Inspection Readiness Training Course (Including Mock Activity) (Day 2 of 2, Separate Registration Required)

    Chemistry, Manufacturing & Control (CMC) regulatory compliance strategy encompasses those activities that a manufacturer is required/expected to be carried out by a regulatory authority to protect the patient from the manufactured drug product. Such activities involve Genetic Development, Process Development, Analytical Development Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs. The coordination and timely completion of all the activities by all these CMC groups is necessary for entering clinical development and for continuing to eventually obtain market approval. CMC teams have varying degrees of experience and may not fully appreciate the significant differences and extra challenges in the CMC regulatory compliance strategy for the diverse group of biopharmaceuticals – both those that are protein-based (recombinant proteins, monoclonal antibodies, bispecific antibodies, Fc fusion proteins, Fab fragments, and antibody-drug conjugates (ADCs), as well as biosimilars) and those that are nucleic acid-based (viral and non-viral gene therapy vectors, genetically modified patient cells). Examples of CMC strategies that worked and those that did not work will be discussed.

    This training course will provide insights and practical guidance for the CMC teams to develop a cost-effective, risk-based CMC regulatory compliant strategy for the manufacture and control of biopharmaceuticals from first-in-human (FIH) clinical studies through market approval. The training course emphasis will include CMC regulatory guidance (FDA, EMA and ICH), as well as real-world case examples illustrating CMC regulatory compliance delays in advancing clinical development and blocking market approval.

    Training Course Information and Registration

  • Quality and Compliance Management for Virtual Companies Training Course (Day 2 of 2, Separate Registration Required)

    Many biotech companies and some pharma companies today are small, “virtual” organizations that outsource most GxP-governed activities such as clinical trials, manufacturing, packaging, laboratory testing, and drug safety monitoring. Such companies often lack in-house knowledge of GCP, GLP and GMP requirements, or have such knowledge vested in very few people. The prospect of an FDA inspection can be a daunting one, as can ensuring that your vendors will pass FDA scrutiny.

    This training course will help you understand what you need to have in place, what the high-risk areas are, and how best to manage those risks as you grow and bring activities in-house. This training course explains the GMP, GCP and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities.

    Training Course Information and Registration

  • Decision-Making in Pharma Manufacturing: Ethics, Compliance, and Resilience Training Course

    Ethics stands at the core of pharmaceutical manufacturing excellence. When ethical standards falter, the consequences extend beyond regulatory penalties to patient harm, facility closures, and lasting damage to industry trust.

    PDA’s new comprehensive training course empowers professionals to strengthen ethical decision-making capabilities essential for patient safety, organizational integrity, and industry advancement. PDA President and CEO Glenn E. Wright has shared that “This new course offering fills a critical gap that we identified during our industry wide review of available courses, regulatory inspection reports, and action letters. It’s the foundation that everything our industry is built upon.”

    Training Course Information and Registration

Activities and Networking Opportunities

Connect and Collaborate with Purpose
Net
Tuesday, 09 September
Lincoln's Last Night Walking Tour

Trace the events of one of America’s most infamous nights on this immersive walking tour through downtown Washington, DC. Led by an expert guide, you’ll explore the three-pronged conspiracy to bring down the U.S. government with coordinated attacks on President Lincoln, Secretary Seward, and Vice President Johnson.

Visit key sites like the White House, Lafayette Square, Seward’s home, the Kirkwood House Hotel, Ford’s Theatre, and Peterson’s Boarding House—where Lincoln spent his final hours. Along the way, uncover lesser-known stories of the conspirators’ escape through Baptist Alley, a failed kidnapping plot, and the personal toll on Lincoln’s family.

This unforgettable tour blends history, tragedy, and resilience—offering a powerful look at the night that changed America.

Price: $40 per person – includes private guided walking tour with professional, live tour guides

Limit: 50 people max.

Time: 19:00 – 21:00 EDT
19:00 Tour departs from Westin lobby
21:00 Tour returns to Westin

Notes: A jacket or sweater is recommended as evening temperatures can dip as low as 55°F (13°C)

Already Registered?
Add Tour to Existing Registration

Program Planning Committee

The Team Behind the Event's Agenda

  • Karyn M. Campbell

    AbbVie Inc.

    Senior Director, QA Audit and Compliance

    Read Bio

  • Francesco Cicirello, PharmD, MSc

    BioNTech

    Senior Director Global BioNTainer Quality Compliance

    Read Bio

  • Irving Ford, MSc

    Adaptimmune

    VP of Quality

    Read Bio

  • Marc Glogovsky, MS

    ValSource, Inc.

    Business Unit Manager - Microbiology

    Read Bio

  • Andrew D. Hopkins, PGDip

    Lachman Consultants

    Senior Director

    Read Bio

  • Al Kentrup

    CISPAC LLC

    Owner

    Read Bio

  • Erika A. Pfeiler, PhD

    ValSource, Inc.

    Senior Consultant - Microbiology

    Read Bio

  • Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Distinguished Fellow

    Read Bio

  • Eva M. Urban, MSc

    Bristol Myers Squibb

    Senior Director, Risk Management

    Read Bio

Promotions and Press

Promote the Conference
Get Shareable Images and Posts
Request Press Pass
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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.

The Westin DC Downtown

999 9th Street, NW
Washington, 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 Logistics Team to inquire about a sub-block.

Make a Reservation Online

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
By Air

The Westin DC Downtown is accessible from three (3) major airports:

  • DCA (Ronald Reagan Washington National Airport – approx. 5 miles/8 km)
  • IAD (Washington Dulles International Airport – approx. 29 miles/47 km)
  • BWI (Baltimore/Washington International Thurgood Marshall Airport – approx. 32 miles/51 km)
By Car

On-site parking is available at the Westin DC Downtown at the following rates:

  • Hourly Self-Park: $11 USD
  • Daily Self-Park: $48 USD
  • Valet: $69 USD
By Other Options

The closest Metro stops to the Westin DC Downtown are:

  • Gallery Place-Chinatown (Green/Red/Yellow lines - approx. 0.3 mile/0.5 km)
  • Metro Center (Blue/Orange/Red/Silver lines - approx. 0.4 mile/0.6 km)

The closest train station to the Westin DC Downtown is Union Station DC (WAS – approx. 1 mile/2 km), which is serviced by:

  • Amtrak
  • MARC (Maryland Rail Commuter Service)
  • VRE (Virginia Railway Express)
  • Metro (Washington Metropolitan Area Transit Authority)
Area Attractions

Registration

Pricing Options

Early Registration

Register by 05 August 2025

Member Price

$2,395

GovernmentMember 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

$2,895

GovernmentMember Only

$895

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$895

Non-Member

$3,295

See Qualifying Criteria for Member Types.
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.

Presenters

Meet the Experts
  • Ruhi Ahmed, PhD, RAC

    Ruhi Ahmed, PhD, RAC

    FLAG Therapeutics, Inc.

    Senior Vice President

    Interest Group Leader
    Read Bio

  • Carmen C. Araujo, MBA

    Takeda

    Senior Vice President, Head Global Quality Audit and Supplier Quality

    Presenter
  • Anamitro Banerjee, PhD

    Anamitro Banerjee, PhD

    AstraZeneca

    Director, CMC Regulatory Affairs

    Panelist
    Read Bio

  • Elif Seyma Bayrak, PhD

    Amgen

    Director, Data Sciences

    Presenter
  • Tara Gooen Bizjak, MBS

    Tara Gooen Bizjak, MBS

    U.S. FDA

    Associate Director, GMP and Quality Standards, OC, CDER

    Moderator
    Presenter
    Read Bio
  • Jeff R. Broadfoot, MBA

    Jeff R. Broadfoot, MBA

    Emergent BioSolutions Inc.

    Senior Director, Quality

    Panelist
    Read Bio

  • Sanat Chattopadhyay

    Merck & Co., Inc.

    Executive Vice President & President, Merck Manufacturing Division

    Presenter
    Read Bio

  • Matthew Cushing

    Nelson Labs

    Vice President, Quality and Science

    Panelist
  • Elizabeth David, MS

    Elizabeth David, MS

    Johnson & Johnson

    Vice President, IM Supply Chain Quality, Advanced Therapies

    Presenter
    Read Bio
  • Josh Eaton, MS

    Josh Eaton, MS

    PDA

    Senior Director, Scientific and Regulatory Affairs

    Panelist
    Read Bio

  • Constance Y. Fears, JD, PhD

    Polymath Regulatory Consultants

    CEO and Principal Consultant

    Panelist
  • Jill Furman, JD

    Jill Furman, JD

    U.S. FDA

    Director, OC, CDER

    Presenter
    Read Bio
  • Charles Gibbons

    Charles Gibbons

    Lachman Consultants

    Director, Data Integrity & Data Governance

    Presenter
    Read Bio
  • Marc Glogovsky, MS

    Marc Glogovsky, MS

    ValSource, Inc.

    Business Unit Manager - Microbiology

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Francis R.W. Godwin, MBA

    Francis R.W. Godwin, MBA

    U.S. FDA

    Office Director, OMQ, OC, CDER

    Presenter
    Read Bio
  • Michael D. Grischeau

    Michael D. Grischeau

    AbbVie Inc.

    Director of Data Analytics and Management Review

    Presenter
    Read Bio
  • Ghada N. Haddad, PhD

    Ghada N. Haddad, PhD

    Kite Pharma

    Head of Global Quality Systems and Quality Processes

    Interest Group Leader
    Read Bio
  • Kir F. Henrici

    Kir F. Henrici

    The Henrici Group

    Chief Executive Officer

    Interest Group Leader
    Read Bio

  • Paul Houri, MS, MBA

    Bristol Myers Squibb

    Senior Vice President, Chief Quality Officer

    Panelist
  • Richard Jaenisch, MPH

    Richard Jaenisch, MPH

    Open Biopharma Research and Training Institute

    Director of Education and Outreach

    Presenter
    Read Bio

  • J. Paul Kirwan, PhD

    Amgen

    Senior Manager, Global Regulatory Affairs CMC

    Panelist
  • Andrea Kurz

    Andrea Kurz

    F. Hoffmann-La Roche Ltd. / EFPIA

    Senior Director External Advocacy Europe and Middle East

    Presenter
    Read Bio
  • Hue Kwon, PhD

    Hue Kwon, PhD

    SOBI

    Global Head Quality External Operations

    Interest Group Leader
    Read Bio
  • Toni Manzano, PhD

    Toni Manzano, PhD

    Aizon

    Co-Founder and CSO

    Presenter
    Read Bio
  • Amanda McFarland, MS

    Amanda McFarland, MS

    ValSource, Inc.

    Senior Consultant

    Interest Group Leader
    Read Bio
  • Melissa J. Mendoza, JD

    Melissa J. Mendoza, JD

    U.S. FDA

    Director, OCBQ, CBER

    Presenter
    Read Bio
  • Jeffrey D. Meng, MSE

    Jeffrey D. Meng, MSE

    U.S. FDA

    Program Division Director, OII

    Panelist
    Read Bio

  • Chad Minks, MBA

    Baxter

    Senior Director, Quality

    Presenter
  • Malav Parikh, ME

    Malav Parikh, ME

    Takeda

    Director, Quality Risk Management, Global Quality Compliance and Systems

    Interest Group Leader
    Read Bio
  • Karin Ann Payne, MBA, MLS

    Karin Ann Payne, MBA, MLS

    Bristol Myers Squibb

    Vice President, Corporate Quality

    Presenter

  • Maja Herold Pedersen, MSc

    FUJIFILM Biotechnologies

    Chief Quality Officer

    Panelist

  • Adrian (Ad) Rawcliffe

    Adaptimmune

    Chief Executive Officer

    Panelist
  • Melissa S. Seymour, MBA

    Melissa S. Seymour, MBA

    Eli Lilly and Company

    EVP and Chief Quality Officer

    Presenter
    Read Bio
  • Michele Simone

    Michele Simone

    Bracco

    Director, Corporate Quality Compliance, Risk Management, and Continual Improvement

    Interest Group Leader
    Read Bio

  • Ivy E. Sweeney, PhD

    U.S. FDA

    Deputy Director, Office of Human and Animal Drug Inspectorate, OII

    Presenter
  • Eva M. Urban, MSc

    Eva M. Urban, MSc

    Bristol Myers Squibb

    Senior Director, Risk Management

    Committee Member
    Interest Group Leader
    Moderator
    Read Bio

  • Sara Voit

    Eli Lilly and Company

    Associate Vice President, Global MQ Learning & Development

    Presenter

  • Brad Warsen

    Biogen

    Executive Director, Corporate Quality

    Presenter
  • Alicja Wolska, MS

    Alicja Wolska, MS

    Merck & Co., Inc.

    Executive Director, Digital & Data Quality

    Presenter

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