PDA Regulatory Conference 2025 - Archived

Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle

07 - 12 Sep 2025
Available In Person or Online via Livestream
Washington, DC

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

Become a Sponsor and/or Exhibitor

Learn More
Browse
Missed the most recent action? Catch up now!

Explore highlights, key moments, and insights from our recent event. Dive into the recap and stay informed!

View Event Recap
The Industry's Most Trusted CGMP Conference—Now Available Via Livestream

Whether you join us in Washington, DC or virtually from anywhere in the world, the PDA Regulatory Conference 2025 delivers the same trusted content. Gain actionable insights through focused sessions, 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.

Livestream participants benefit from:

  • Live access to all plenary and concurrent sessions
  • Interactive Q&A with FDA leaders and industry experts
  • Comprehensive coverage of regulatory trends, compliance strategies, and FDA priorities
  • On-demand session recordings to revisit key insights at your convenience
Livestream Registration

Returning to Washington, DC for the 34th year, PDA's September regulatory conference remains the pharmaceutical industry’s most trusted forum for open, informed dialogue between global regulators and industry professionals. For more than three decades, this event has provided the insights needed to strengthen compliance, advance quality systems, and protect patients worldwide.

The PDA Regulatory Conference 2025 agenda builds on this legacy with a strong focus on advancing effective quality systems across the product lifecycle, with U.S. FDA participation woven throughout. Sessions 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 perspectives, 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.

Special Pre-Conference Roundtable: Join PDA’s Capital Area Chapter on Sunday, 07 September at 16:00 EDT for a Roundtable on FDA Complete Response Letters (CRLs). 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. All roundtable registration fees will be donated to the PDA Jette Christensen Early Career Professional Grant, supporting the next generation of pharma leaders.

Extend Your Learning: Immediately following the Conference, PDA will offer a suite of in-depth workshops and training courses to translate insights into hands-on application:

Registration is now open–secure your spot today!

PDA GPS Student Experience

Volunteer at the PDA Regulatory Conference 2025 and receive complimentary registration—gain access to sessions, networking, and real-world insight into the regulatory landscape.

Sign Up Today!

Agenda

Discover What's Happening Each Day
Download Full Agenda (PDF) Explore the full program with detailed session information.
(Note: The file may take a moment to download depending on your connection.)
Download Agenda at a Glance (PDF) Get a concise overview of the event schedule with this summarized agenda.
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)

Wednesday, 10 September

EDT Daylight Time (UTC -4:00)

Thursday, 11 September

EDT Daylight Time (UTC -4:00)

  • Registration Open | PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop (Rock Creek Ballroom Registration Desk)

    Rock Creek Ballroom Registration Desk

  • PDA/PQRI Advancing Artificial Intelligence in the Pharmaceutical Industry Workshop 2025 (Rock Creek B/C) (Day 2 of 2 - Separate Registration Required)

    Rock Creek B/C

    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.

    Workshop Information and Registration

  • Aseptic Processing Essentials Workshop (MR 13) (Separate Registration Required)

    MR 13

    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 (MR 13) (Day 1 of 2, Separate Registration Required)

    MR 14

    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 (MR 12) (Separate Registration Required)

    MR 12

    This essentials workshop will dive into the practical application of contamination control strategy (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

  • Fundamentals of Quality Risk Management Training Course (MR 15) (Separate Registration Required)

    MR 15

    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

  • GxP Auditing Logistics and Inspection Readiness Training Course (Including Mock Activity) (MR 16) (Day 1 of 2, Separate Registration Required)

    MR 16

    This comprehensive training course is designed for pharmaceutical manufacturers and pharmacists who want to deepen their understanding of the auditing process. Participants will gain essential insights into how audits are conducted within the pharmaceutical industry, focusing on compliance with regulatory standards, quality management, and risk assessment.

    Training Course Information and Registration

  • Measuring Quality Culture using PDA's Assessment Tool Training Course (MR 10) (Separate Registration Required)

    MR 10

    In this training course, you will learn how to use PDA’s comprehensive Quality Culture Assessment 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 (MR 15) (Day 1 of 2, Separate Registration Required)

    MR 15

    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
Friday, 12 September

EDT Daylight Time (UTC -4:00)

  • CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course (MR 14) (Day 2 of 2, Separate Registration Required)

    MR 14

    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) (MR 16) (Day 2 of 2, Separate Registration Required)

    MR 16

    This comprehensive training course is designed for pharmaceutical manufacturers and pharmacists who want to deepen their understanding of the auditing process. Participants will gain essential insights into how audits are conducted within the pharmaceutical industry, focusing on compliance with regulatory standards, quality management, and risk assessment.

    Training Course Information and Registration

  • Quality and Compliance Management for Virtual Companies Training Course (MR 15) (Day 1 of 2, Separate Registration Required)

    MR 15

    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

Activities and Networking Opportunities

Connect and Collaborate with Purpose
Net
Tuesday, 09 Sep | 19:00–21:00 EDT
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.

Attendance is limited to 50 participants, and this unique tour fills quickly—reserve your spot today!

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

Notes: The tour departs from the Westin lobby promptly at 19:00 EDT and returns at 21:00 EDT. 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

Tuesday, 09 Sep | 18:00–21:00 EDT
PDA Capital Area Chapter: Whiskey State of Mind—Annual Networking Social

Join the PDA Capital Area Chapter for their 4th annual Whiskey State of Mind networking social at Crimson Whiskey Bar! Open to all—whether or not you’re a Capital Area Chapter member—this event offers an evening of unforgettable connections, bringing together professionals from biotech, pharma, and the life sciences.

Attendance is limited to 250 participants, and this event sells out every year—be sure to register early!

Price: $15 per person – includes two complimentary drinks, delicious food, great music, and a vibrant venue atmosphere

Celebrate with the PDA Capital Area Chapter
Purchase a Whiskey State of Mind Ticket

Program Planning Committee

The Team Behind the Event's Agenda

  • Paul Z. Balcer

    U.S. FDA

    Consumer Safety Officer, OMQ, OC, CDER

    Read Bio

  • Tara Gooen Bizjak, MBS

    U.S. FDA

    Associate Director, GMP and Quality Standards, OC, CDER

    Read Bio

  • Zachary Bogorad

    U.S. FDA

    Compliance Officer, OC, CDER

    Read Bio

  • 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

  • Christopher Downey, PhD

    U.S. FDA

    Director, Division of Pharmaceutical Manufacturing Assessment VI, OPMA, OPQ, CDER

    Read Bio

  • Irving Ford, MSc

    Quality Leader

    Read Bio

  • Michele Forster, PhD

    U.S. FDA

    Associate Director for Manufacturing Quality, OCBQ, CBER

    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

  • Francis R.W. Godwin, MBA

    U.S. FDA

    Office Director, OMQ, OC, CDER

    Read Bio

  • Andrew D. Hopkins, PGDip

    Lachman Consultants

    Senior Director

    Read Bio

  • Mai X. Huynh, MS

    U.S. FDA

    Supervisory Chemist, ONADE, CVM

    Read Bio

  • Al Kentrup

    NPG

    Executive Advisor

    Read Bio

  • Andrea K. Kerrigan, MS

    U.S. FDA

    Branch Chief, OGAD, CVM

    Read Bio

  • Lily Y. Koo, PhD

    U.S. FDA

    Biomedical Engineer, CBER

    Read Bio

  • Shawn Larson, PhD

    U.S. FDA

    Development Coordinator, OACII, OII

    Read Bio

  • Erika A. Pfeiler, PhD

    ValSource, Inc.

    Senior Consultant - Microbiology

    Read Bio

  • Nelson E. Rivera, JD

    U.S. FDA

    Consumer Safety Officer, OC, CDER

    Read Bio

  • Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Distinguished Fellow

    Read Bio

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.

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, 22 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

Standard Registration

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.
Attendance Options

PDA offers participants the flexibility to attend the Regulatory Conference either in person in Washington, DC, or virtually via livestream. The table below outlines what is included with each option:

 IN PERSONLIVESTREAM
Plenary Sessions✓✓
Concurrent Sessions✓✓
Ability to Submit Questions for Q&A✓✓
Breakfast Sessions✓Post-conference audio recordings only
Lunch with the Regulators✓Post-conference audio recording only
Interest Group Meetings with FDA Co-Facilitators✓✗
Exhibit Area✓✗
Monday Networking Reception✓✗
In-Person Networking with Industry and Regulatory Experts✓✗

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].

Presenters

PDA events bring together top-notch industry experts, innovators, and practitioners who are shaping the future of pharmaceutical science and manufacturing. Our presenters are selected for their experience, insight, and commitment to elevating the global community through knowledge sharing.

  • Maan Abduldayem, MBA

    Maan Abduldayem, MBA

    U.S. FDA

    Supervisor, OC, CDER

    Panelist
    Read Bio
  • Nidia Acevedo, PhD

    Nidia Acevedo, PhD

    Eli Lilly and Company

    Senior Vice President, Global Quality Compliance

    Presenter
    Read Bio
  • Ruhi Ahmed, PhD, RAC

    Ruhi Ahmed, PhD, RAC

    FLAG Therapeutics, Inc.

    Senior Vice President

    Interest Group Leader
    Read Bio
  • Ekaterina Allen, PhD, RAC

    Ekaterina Allen, PhD, RAC

    U.S. FDA

    Pharmaceutical Scientist, OPQ, CDER

    Panelist
    Presenter
    Read Bio
  • Kristen L. Anderson, PhD

    Kristen L. Anderson, PhD

    U.S. FDA

    Microbiologist, ONADE, CVM

    Panelist
    Read Bio
  • Carmen C. Araujo, MBA

    Carmen C. Araujo, MBA

    Takeda

    Senior Vice President, Head Global Quality Audit and Supplier Quality

    Presenter
    Read Bio
  • Peter Baker, MS

    Peter Baker, MS

    Live Oak Quality Assurance LLC

    President

    Presenter
    Read Bio
  • Anamitro Banerjee, PhD

    Anamitro Banerjee, PhD

    AstraZeneca

    Director, CMC Regulatory Affairs

    Panelist
    Read Bio
  • Sarah R. Barkow, PhD

    Sarah R. Barkow, PhD

    AstraZeneca

    Senior Director Proactive Compliance and Innovation

    Presenter
    Read Bio
  • Elif Seyma Bayrak, PhD

    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

    Committee Member
    Moderator
    Panelist
    Presenter
    Read Bio
  • Jeff Broadfoot, MBA

    Jeff Broadfoot, MBA

    Emergent BioSolutions Inc.

    Vice President, Quality Operations

    Panelist
    Read Bio
  • Vinny Browning, MS

    Vinny Browning, MS

    Amgen

    Executive Director Quality Assurance

    Presenter
    Read Bio
  • Cindy L. Burnsteel, DVM

    Cindy L. Burnsteel, DVM

    U.S. FDA

    Deputy Director for Drugs and Devices, OSC, CVM

    Presenter
    Read Bio
  • Cristiana Campa, PhD

    Cristiana Campa, PhD

    GSK

    External CMC Intelligence Lead

    Panelist
    Presenter
    Read Bio
  • Christina Capacci-Daniel, PhD

    Christina Capacci-Daniel, PhD

    U.S. FDA

    Compliance Officer, OMQ, OC, CDER

    Panelist
    Read Bio
  • Tamika D Cathey

    Tamika D Cathey

    National Sanitation Foundation

    Global Principal Program Lead - Pharma Biotech

    Panelist
    Read Bio
  • Sanat Chattopadhyay

    Sanat Chattopadhyay

    Merck & Co., Inc.

    Executive Vice President & President, Merck Manufacturing Division

    Presenter
    Read Bio
  • Thomas J Cosgrove, JD

    Thomas J Cosgrove, JD

    Covington & Burling LLP

    Partner

    Presenter
    Read Bio
  • Shaun Crofts

    Shaun Crofts

    Gilead

    Executive Director, External Quality Operations

    Presenter
    Read Bio
  • Matthew Cushing

    Matthew Cushing

    Nelson Labs

    Vice President, Quality and Science

    Panelist
    Read Bio
  • Elizabeth David, MS

    Elizabeth David, MS

    Johnson & Johnson

    Vice President, IM Supply Chain Quality, Advanced Therapies

    Presenter
    Read Bio
  • Maya Davis, PhD

    Maya Davis, PhD

    ELIQUENT Life Sciences

    Senior Vice President, Regulatory Compliance

    Presenter
    Read Bio
  • Laura K. DeMaster, PhD

    Laura K. DeMaster, PhD

    U.S. FDA

    Gene Therapy CMC Reviewer, OTP, CBER

    Panelist
    Read Bio
  • Matthew R. Dionne, PharmD, MBA, BCPS

    Matthew R. Dionne, PharmD, MBA, BCPS

    U.S. FDA

    Regulatory Officer, OC, CDER

    Panelist
    Read Bio
  • Hesha J. Duggirala, PhD, MPH

    Hesha J. Duggirala, PhD, MPH

    U.S. FDA

    Epidemiologist and AI Center Lead, OSC, CVM

    Panelist
    Read Bio
  • Katharine K. Duncan, PhD

    Katharine K. Duncan, PhD

    GSK

    Director CMC Policy and Advocacy

    Panelist
    Read Bio
  • Josh Eaton, MS

    Josh Eaton, MS

    PDA

    Senior Director, Scientific and Regulatory Affairs

    Panelist
    Read Bio
  • Ossama Eissa, MBA

    Ossama Eissa, MBA

    Cellares

    Chief Operating Officer

    Presenter
    Read Bio
  • Donald B. Ertel, MS, MT (ASCP)

    Donald B. Ertel, MS, MT (ASCP)

    U.S. FDA

    Branch Chief / Program Manager, OCBQ, CBER

    Panelist
    Read Bio
  • Constance Y. Fears, JD, PhD

    Constance Y. Fears, JD, PhD

    Polymath Regulatory Consultants

    CEO and Principal Consultant

    Panelist
    Read Bio

  • Rebecca Frey-Cooper, PhD

    U.S. FDA

    Associate Director for Regulatory Programs, OC, CDER

    Panelist
  • Jill Furman, JD

    Jill Furman, JD

    U.S. FDA

    Director, OC, CDER

    Presenter
    Read Bio
  • Abhinay Gajula, MBA

    Abhinay Gajula, MBA

    ComplianceQuest

    Manager - Product Marketing & Technology

    Panelist
    Read Bio
  • Milind Ganjawala, MS, MBA

    Milind Ganjawala, MS, MBA

    U.S. FDA

    Division Director, DDQ, OMQ, OC, CDER

    Panelist
    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

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Patrick Gregorowicz

    Patrick Gregorowicz

    bioMérieux

    Sr. Director Operations

    Presenter
    Read Bio
  • Michael D. Grischeau

    Michael D. Grischeau

    AbbVie Inc.

    Director of Data Analytics and Management Review

    Presenter
    Read Bio
  • Markus A. Gruell, MSc

    Markus A. Gruell, MSc

    Autolus Ltd.

    Senior Vice President Head of Quality

    Presenter
    Read Bio
  • Ghada N. Haddad, PhD

    Ghada N. Haddad, PhD

    Kite Pharma

    Head of Global Quality Systems and Quality Processes

    Interest Group Leader
    Panelist
    Presenter
    Read Bio
  • Lothar Halmer, PhD

    Lothar Halmer, PhD

    Boehringer Ingelheim

    Chief Quality Officer

    Panelist
    Read Bio
  • Kir Henrici

    Kir Henrici

    The Henrici Group

    President

    Interest Group Leader
    Read Bio
  • Brooke K. Higgins, MS

    Brooke K. Higgins, MS

    ELIQUENT Life Sciences

    Senior Vice President, Regulatory Compliance

    Panelist
    Read Bio
  • Paul Houri, MS, MBA

    Paul Houri, MS, MBA

    Bristol Myers Squibb

    Senior Vice President, Chief Quality Officer

    Panelist
    Read Bio
  • Richard Jaenisch, MPH

    Richard Jaenisch, MPH

    Open Biopharma Research and Training Institute

    Senior Director of Education, Outreach and Digital Experience

    Presenter
    Read Bio
  • Martin S. Jenkins, PMP

    Martin S. Jenkins, PMP

    Circle MJ Consulting

    Senior Project Manager, Qualification and Validation

    Presenter
    Read Bio
  • Juan Jimenez, JD

    Juan Jimenez, JD

    U.S. Food and Drug Administration, CVM, CGMP Compliance

    Consumer Safety Officer

    Panelist
    Read Bio
  • Rebecca D. Jordan

    Rebecca D. Jordan

    Bristol Myers Squibb

    Director, Global Cell Therapy Sterility Assurance Lead

    Presenter
    Read Bio
  • J. Paul Kirwan, PhD

    J. Paul Kirwan, PhD

    Amgen

    Senior Manager, Global Regulatory Affairs CMC

    Panelist
    Read Bio
  • Michael R. Klapal, MSc

    Michael R. Klapal, MSc

    U.S. FDA

    Consumer Safety Officer, OC, CDER

    Panelist
    Read Bio
  • Ulrich Koellisch, PhD

    Ulrich Koellisch, PhD

    GxP-CC

    Partner

    Interest Group Leader
    Read Bio
  • Andrea Kurz

    Andrea Kurz

    F. Hoffmann-La Roche Ltd.

    Senior Director External Advocacy Europe and Middle East

    Presenter
    Read Bio
  • Shawn Larson, PhD

    Shawn Larson, PhD

    U.S. FDA

    Development Coordinator, OACII, OII

    Committee Member
    Moderator
    Panelist
    Read Bio
  • Eric A. Levenson, PhD

    Eric A. Levenson, PhD

    U.S. FDA

    Biological Reviewer, OTP, CBER

    Panelist
    Read Bio
  • Robin Levis, PhD

    Robin Levis, PhD

    U.S. FDA

    Deputy Director, Division of Viral Products, OVRR, CBER

    Panelist
    Read Bio
  • Eric T. Ludewig, MBA

    Eric T. Ludewig, MBA

    Takeda

    Head, Operational Compliance, Global Quality Audit and Supplier Quality

    Presenter
    Read Bio
  • Toni Manzano, PhD

    Toni Manzano, PhD

    Aizon

    CSO and Compliance Officer

    Presenter
    Read Bio
  • Amanda McFarland, MS

    Amanda McFarland, MS

    ValSource, Inc.

    Senior Consultant

    Interest Group Leader
    Read Bio
  • Scott Meikle, MS

    Scott Meikle, MS

    Ecolab

    SVP Global Technical Organization

    Presenter
    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

    Associate Director, Emerging Technologies and Advanced Manufacturing, Medical Products Inspectorate, OII

    Panelist
    Read Bio
  • Benjamin Mills

    Benjamin Mills

    Rx-360

    Senior Director, Operations (Joint Audit Program/Quality)

    Panelist
    Read Bio
  • Chad Minks, MBA

    Chad Minks, MBA

    Baxter

    Sr. Director - Site Quality Head

    Presenter
    Read Bio
  • Christopher A. Murdock, PhD, CQA

    Christopher A. Murdock, PhD, CQA

    Eli Lilly and Company

    VP, Sterility Assurance and Microbiology Support

    Presenter
    Read Bio
  • Jimi Olaghere

    Jimi Olaghere

    Sugarloaf Capital

    Gene Editing Recipient and Patient Advocate

    Presenter
    Read Bio
  • 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
    Read Bio
  • Maja H. Pedersen, MSc

    Maja H. Pedersen, MSc

    FUJIFILM Biotechnologies

    Chief Technology Officer, EVP

    Panelist
    Read Bio
  • Marla A. Phillips, PhD

    Marla A. Phillips, PhD

    Pathway for Patient Health

    CEO and President

    Panelist
    Presenter
    Read Bio
  • Olufemi Rabiu, PhD

    Olufemi Rabiu, PhD

    Innoviva Specialty Therapeutics

    SVP, Head of Quality

    Presenter
    Read Bio
  • Nandini Rakala, PhD

    Nandini Rakala, PhD

    U.S. FDA

    Data Scientist | Visiting Associate, OPQ, CDER

    Panelist
    Read Bio
  • Adrian (Ad) Rawcliffe

    Adrian (Ad) Rawcliffe

    Adaptimmune

    Chief Executive Officer

    Panelist
    Read Bio
  • Sabrina Restrepo, PhD

    Sabrina Restrepo, PhD

    Merck & Co., Inc.

    Executive Director - Quality Assurance

    Presenter
    Read Bio
  • Nelson E. Rivera, JD

    Nelson E. Rivera, JD

    U.S. FDA

    Consumer Safety Officer, OC, CDER

    Committee Member
    Moderator
    Panelist
    Read Bio
  • Dr. Carmelo Rosa

    Dr. Carmelo Rosa

    U.S. FDA

    Division Director, Office of Manufacturing and Product Quality, OC, CDER

    Panelist
    Presenter
    Read Bio

  • Jason A. Rossi, MS

    U.S. FDA

    Chemist, ONAPE, CVM

    Panelist
    Read Bio
  • Anil D. Sawant, PhD

    Anil D. Sawant, PhD

    Merck & Co., Inc.

    Senior Vice President, Global Quality Transformation

    Panelist
    Read Bio
  • Sebastian Scheler, MSc

    Sebastian Scheler, MSc

    Innerspace

    Managing Director

    Panelist
    Read Bio
  • Susan J. Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Distinguished Fellow

    Committee Member
    Moderator
    Presenter
    Read Bio
  • Melissa S. Seymour, MBA

    Melissa S. Seymour, MBA

    Eli Lilly and Company

    EVP and Chief Quality Officer

    Presenter
    Read Bio
  • Vishal Sharma, MS

    Vishal Sharma, MS

    Vienni Training & Consulting LLP

    Co-Founder - Director

    Interest Group Leader
    Read Bio
  • Michele Simone, PhD

    Michele Simone, PhD

    Bracco

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

    Interest Group Leader
    Read Bio
  • Derek S. Smith, PhD

    Derek S. Smith, PhD

    U.S. FDA

    Deputy Director, OPMA, OPQ, CDER

    Panelist
    Presenter
    Read Bio
  • Jennifer Stone, MBA

    Jennifer Stone, MBA

    PTC Therapeutics

    SVP, Quality

    Presenter
    Read Bio
  • Ivy E. Sweeney, PhD

    Ivy E. Sweeney, PhD

    U.S. FDA

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

    Panelist
    Presenter
    Read Bio
  • Jonathan G Swoboda, PhD

    Jonathan G Swoboda, PhD

    U.S. FDA

    Consumer Safety Officer, OCBQ, CBER

    Presenter
    Read Bio

  • Stelios C Tsinontides, PhD, FAIChE

    Merck & Co., Inc.

    Vice President, Global Quality, Quality Management Systems, Transformation & External Advocacy

    Panelist
    Read Bio
  • Eva M. Urban, MSc

    Eva M. Urban, MSc

    Bristol Myers Squibb

    Senior Director, Risk Management

    Interest Group Leader
    Moderator
    Read Bio
  • Swati Verma, PhD

    Swati Verma, PhD

    U.S. FDA

    Biologist, OVRR, CBER

    Panelist
    Read Bio
  • Sara Voit, MSPH

    Sara Voit, MSPH

    Eli Lilly and Company

    Associate Vice President, Global MQ Learning & Development

    Presenter
    Read Bio
  • Brad Warsen

    Brad Warsen

    Biogen

    Executive Director, Corporate Quality

    Presenter
    Read Bio
  • Alicja Wolska, MS

    Alicja Wolska, MS

    Merck & Co., Inc.

    Executive Director, Digital & Data Quality

    Presenter
    Read Bio
  • Dillard H. Woody

    Dillard H. Woody

    U.S. FDA

    Branch Chief, OSC, CVM

    Panelist
    Read Bio
  • Glenn E. Wright, MA

    Glenn E. Wright, MA

    PDA

    President and CEO

    Moderator
    Presenter
    Read Bio

Sponsors

Sponsors and Collaborators

Exhibitors

Exhibitors and Innovators
Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA's conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become a Sponsor and/or Exhibitor

Amplify Your Presence and Reach Your Customers!
Become a Sponsor

Elevate your brand and maximize your exposure by becoming a sponsor at the PDA Regulatory Conference 2025 - Archived! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.

Request Information
Become an Exhibitor

Boost your brand and visibility by becoming an exhibitor at the PDA Regulatory Conference 2025 - Archived! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

Request Information

Promotions and Press

Request Press Pass
Submit Your Information

Explore Our Global Events Calendar

Stay Connected with Our Upcoming Events!
Global Events Calendar
Contact Us
Have a question or need assistance?

Send us a message, and our team will get back to you shortly. We're here to help!

Contact

Program Inquiries
Tel: +1 (301) 656-5900
Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405
Training Course Inquiries
Tel: +1 (301) 656-5900
Registration Customer Care
Tel: +1 (301) 656-5900