XN 2021 Test Event

26 - 29 Sep 2021

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Event information coming soon.

Promotions and Press

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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.

Registration

Pricing Options

More information coming soon.

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

Meet the Experts
  • Atul J Agrawal, MS

    Atul J Agrawal, MS

    U.S. FDA

    Supervisory Consumer Safety Officer, OPQO, ORA

    Regulatory Panelist
    Read Bio
  • Maria C.H. Anderson, MS

    Maria C.H. Anderson, MS

    U.S. FDA

    Branch Chief, Biological Drug and Device Compliance Branch, OCBQ, CBER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Donald D Ashley, JD

    Donald D Ashley, JD

    U.S. FDA

    Director, OC, CDER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • John D Ayres, MD

    John D Ayres, MD

    Pharma Safety Solutions, LLC

    Risk Assessment Clinician

    Moderator
    Read Bio
  • Denyse D. Baker, PE, RAC

    Denyse D. Baker, PE, RAC

    Eli Lilly and Company

    AVP Global Quality Compliance

    Panelist
    Presenter
    Read Bio
  • Tiffany A. Baker, MBA

    Tiffany A. Baker, MBA

    ValSource, Inc.

    Senior Consultant

    Panelist
    Presenter
    Read Bio
  • Paul Z. Balcer

    Paul Z. Balcer

    U.S. FDA

    Program Manager, OMQ, OC, CDER

    Moderator
    Read Bio
  • Robert M Barbosa

    Robert M Barbosa

    U.S. FDA

    Drug Specialist and Pre-Approval Manager, OMPTO, ORA

    Regulatory Panelist
    Read Bio
  • Jeff J Bedford

    Jeff J Bedford

    GlaxoSmithKline

    Director, R&D Quality Futures

    Panelist
    Presenter
    Read Bio
  • Tara Gooen Bizjak, MBS

    Tara Gooen Bizjak, MBS

    U.S. FDA

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

    Moderator
    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Renée S. Blosser, MS

    Renée S. Blosser, MS

    U.S. FDA

    Microbiologist, ONADE, CVM

    Regulatory Panelist
    Read Bio
  • Ashley B Boam, MSBE

    Ashley B Boam, MSBE

    U.S. FDA

    Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Sandra A. Boyd

    Sandra A. Boyd

    U.S. FDA

    Drug National Expert, OMPTO, ORA

    Regulatory Panelist
    Read Bio
  • Jeff R Broadfoot, MBA

    Jeff R Broadfoot, MBA

    Emergent BioSolutions Inc.

    Senior Director, Quality

    Panelist
    Read Bio
  • Cindy L. Burnsteel, DVM

    Cindy L. Burnsteel, DVM

    U.S. FDA

    Deputy Director for Drugs and Devices, OSC, CVM

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Cristiana Campa, PhD

    Cristiana Campa, PhD

    GSK

    Technical R&D Advisor

    Panelist
    Presenter
    Read Bio
  • Douglas A. Campbell

    Douglas A. Campbell

    InterPro QRA

    Senior Consultant

    Moderator
    Read Bio
  • Monica L Casey, RVT

    Monica L Casey, RVT

    U.S. FDA

    Consumer Safety Officer, CVM

    Regulatory Panelist
    Read Bio
  • Patrizia Cavazzoni, MD

    Patrizia Cavazzoni, MD

    U.S. FDA

    Director, Center for Drug Evaluation and Research

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Gang Chen, PhD

    Gang Chen, PhD

    Regeneron Pharmaceuticals, Inc.

    Vice President

    Panelist
    Read Bio
  • David L Chesney, MSJ

    David L Chesney, MSJ

    DL Chesney Consulting, LLC

    Principal and General Manager

    Moderator
    Read Bio
  • Jette Christensen, MSc

    Jette Christensen, MSc

    Novo Nordisk A/S

    Scientific Director

    Chairperson
    Read Bio
  • Alicia D Collins

    Alicia D Collins

    Bristol Myers Squibb

    Senior Director, Cell Therapy Global Product Supply Planning and Management

    Panelist
    Presenter
    Read Bio
  • Conor C. Collins, PhD, MBA, MSc

    Conor C. Collins, PhD, MBA, MSc

    GlaxoSmithKline

    Head of Validation/PLM for Pharma Supply Technical

    Presenter
    Read Bio
  • Carl-Helmut Coulon, PhD

    Carl-Helmut Coulon, PhD

    INVITE GmbH

    Head of Future Manufacturing Concepts

    Panelist
    Presenter
    Read Bio
  • Darrin J Cowley, PhD

    Darrin J Cowley, PhD

    AstraZeneca

    Vice President Head of Developmental Quality, Biologics

    Panelist
    Presenter
    Read Bio
  • Alonza E. Cruse

    Alonza E. Cruse

    U.S. FDA

    Director, Office Pharmaceutical Quality Operations, ORA

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Biswarup Dasgupta, MS

    Biswarup Dasgupta, MS

    Vertex Pharmaceuticals

    Site Quality Head, VMC

    Panelist
    Presenter
    Read Bio
  • Pamela C De Moor, MS, PhD

    Pamela C De Moor, MS, PhD

    Vir Biotechnology, Inc

    Senior Director, Formulations and Drug Product Development

    Panelist
    Presenter
    Read Bio
  • Kathy A Demarest

    Kathy A Demarest

    Amgen Inc.

    Executive Director, Quality

    Panelist
    Presenter
    Read Bio
  • Andrew Dick, MS

    Andrew Dick, MS

    KDC/One

    Vice President Global Hygiene and Microbiology

    Panelist
    Presenter
    Read Bio
  • Denise M DiGiulio

    Denise M DiGiulio

    Genentech

    Head of Global Audit and Inspection Management

    Moderator
    Read Bio
  • Rebecca E. Dowd, MS

    Rebecca E. Dowd, MS

    U.S. FDA

    Program Division Director, OPQO3, ORA

    Moderator
    Read Bio
  • Derek I Duncan, PhD

    Derek I Duncan, PhD

    LIGHTHOUSE Instruments

    Director Product Lines

    Panelist
    Presenter
    Read Bio
  • Michael T Edey, Mr

    Michael T Edey, Mr

    Pfizer Inc.

    Senior Principal Engineer

    Panelist
    Presenter
    Read Bio
  • Paul Edson

    Paul Edson

    Johnson & Johnson

    Vice President, J&J Regulatory Compliance

    Panelist
    Read Bio
  • Mary E. Farbman, PhD

    Mary E. Farbman, PhD

    Merck & Co., Inc.

    Associate Vice President, Global Quality Compliance

    Moderator
    Read Bio
  • Travis A Frick, MSc

    Travis A Frick, MSc

    Biologics / Cell & Gene Therapy Manufacturing

    Manufacturing & Quality Operations Leader

    Panelist
    Presenter
    Read Bio
  • Rick L Friedman, MS

    Rick L Friedman, MS

    U.S. FDA

    Deputy Director, OMQ, OC, CDER

    Moderator
    Regulatory Panelist
    Read Bio
  • Mirko Gabriele, PhD

    Mirko Gabriele, PhD

    InfiniteVision

    CEO

    Panelist
    Presenter
    Read Bio
  • Victor (Ray) Gaines

    U.S. FDA

    Branch Chief, OMQ, OC, CDER

    Regulatory Panelist
    Read Bio
  • Francis RW Godwin, MBA

    Francis RW Godwin, MBA

    U.S. FDA

    Office Director, OMQ, OC, CDER

    Co-Chair
    Moderator
    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Dennis E Guilfoyle, MS, PhD

    Dennis E Guilfoyle, MS, PhD

    Johnson & Johnson

    Senior Director, Microbiology Regulatory Compliance

    Panelist
    Presenter
    Read Bio
  • Maria T Gutierrez Lugo, PhD

    Maria T Gutierrez Lugo, PhD

    U.S. FDA

    Supervisory Chemist, CDER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Sharyl D Hartsock

    Sharyl D Hartsock

    Eli Lilly and Company

    Vice President, US Parenteral Quality

    Moderator
    Read Bio
  • Kir F. Henrici

    Kir F. Henrici

    The Henrici Group

    Chief Executive Officer

    Co-Presenter
    Panelist
    Read Bio
  • Brooke K. Higgins, MS

    Brooke K. Higgins, MS

    U.S. FDA

    Branch Chief, OC, CDER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Peter J Hotez, MD, PhD

    Peter J Hotez, MD, PhD

    Baylor College of Medicine

    Dean National School of Tropical Medicine

    Panelist
    Presenter
    Read Bio
  • Patricia F Hughes, PhD

    Patricia F Hughes, PhD

    U.S. FDA

    Senior Scientific Advisor, OPQ, CDER

    Moderator
    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Clarice H Hutchens, PhD, MA, DM

    Pfizer

    Senior Director

    Moderator
    Read Bio
  • Mai X. Huynh, MS

    Mai X. Huynh, MS

    U.S. FDA

    Supervisory Chemist, ONADE, CVM

    Moderator
    Read Bio
  • Maik W. Jornitz

    Maik W. Jornitz

    BioProcess Resources LLC

    Principal Consultant

    Panelist
    Presenter
    Read Bio
  • Amin Khan, PhD

    GreenLight Biosciences, Inc.

    Chief Science Officer, Human Health

    Panelist
    Read Bio
  • Lily Y Koo, PhD

    Lily Y Koo, PhD

    U.S. FDA

    Biomedical Engineer, CBER

    Regulatory Panelist
    Read Bio
  • Thomas R Kreil, PhD

    Thomas R Kreil, PhD

    Takeda

    Vice President, Global Pathogen Safety

    Panelist
    Presenter
    Read Bio
  • Suzanne Kuiper, PhD

    Suzanne Kuiper, PhD

    Lighthouse Instruments

    Application Manager

    Poster Presenter
    Read Bio
  • Mike G Labruto, MS

    Mike G Labruto, MS

    University of Pennsylvania/Gene Therapy Program

    Executive Director

    Moderator
    Read Bio
  • Stephen E. Langille, PhD

    Stephen E. Langille, PhD

    ValSource, Inc.

    Senior Microbiology Consultant

    Panelist
    Read Bio
  • Michele Lastro, MS, PhD

    Michele Lastro, MS, PhD

    Regeneron Pharmaceuticals, Inc.

    Executive Director

    Panelist
    Presenter
    Read Bio
  • Sau (Larry) L Lee, PhD

    Sau (Larry) L Lee, PhD

    U.S. FDA

    Deputy Director of Science, OPQ, CDER

    Regulatory Panelist
    Read Bio
  • Matthew A. Lucia, DVM

    Matthew A. Lucia, DVM

    U.S. FDA

    Director, Office of New Animal Drug Evaluation, CVM

    Regulatory Panelist
    Read Bio
  • Nicholas F Lyons, MS

    Nicholas F Lyons, MS

    U.S. FDA

    Director of Compliance, Office of Pharmaceutical Quality Operations, ORA

    Regulatory Panelist
    Read Bio
  • Ingrid Markovic, PhD

    Ingrid Markovic, PhD

    U.S. FDA

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

    Moderator
    Read Bio
  • Peter W. Marks, MD, PhD

    Peter W. Marks, MD, PhD

    U.S. FDA

    Director, Center for Biologics Evaluation and Research

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Judith A McMeekin, PharmD

    Judith A McMeekin, PharmD

    U.S. FDA

    Associate Commissioner for Regulatory Affairs, ORA

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • John M McShane, MBA

    John M McShane, MBA

    Lachman Consultant Services, Inc.

    Vice President, BIologics

    Panelist
    Presenter
    Read Bio
  • Melissa J. Mendoza, JD

    Melissa J. Mendoza, JD

    U.S. FDA

    Director, OCBQ, CBER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Frank Montgomery, PhD

    Frank Montgomery, PhD

    AstraZeneca

    Vice President CMC RA

    Panelist
    Presenter
    Read Bio
  • Lisa Newcombe-Dierl

    Lisa Newcombe-Dierl

    Amgen Inc.

    Vice President Corporate Quality

    Panelist
    Presenter
    Read Bio
  • Roger Nosal, MA

    Roger Nosal, MA

    Pfizer

    Vice President, GCMC

    Panelist
    Presenter
    Read Bio
  • Kevin J O'Donnell, PhD

    Kevin J O'Donnell, PhD

    Health Products Regulatory Authority

    Market Compliance Manager

    Presenter
    Regulatory Panelist
    Read Bio
  • Pat C O'Sullivan, MBA

    Pat C O'Sullivan, MBA

    Sanofi

    Vice President Supply Chain for Sanofi Genzyme

    Panelist
    Read Bio
  • Erika A. Pfeiler, PhD

    Erika A. Pfeiler, PhD

    U.S. FDA

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

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Michele H Piepoli

    Michele H Piepoli

    Johnson & Johnson

    Senior Quality Consultant

    Panelist
    Presenter
    Read Bio
  • Simone E. Pitts, MS

    Simone E. Pitts, MS

    U.S. FDA

    National Expert, Pharmaceutical, ORA

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Laura A Plumb

    Laura A Plumb

    Bionique Testing Laboratories

    Associate Scientist

    Poster Presenter
    Read Bio
  • Jim N. Polarine, MA

    Jim N. Polarine, MA

    STERIS

    Principal Consultant

    Poster Presenter
    Read Bio
  • Keduo Qian, PhD

    U.S. FDA

    Chemist, CDER

    Moderator
    Read Bio
  • Mahesh R. Ramanadham, PharmD, MBA

    Mahesh R. Ramanadham, PharmD, MBA

    CDER/OPQ/US FDA

    Deputy Director

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Emabelle Ramnarine, PhD

    Emabelle Ramnarine, PhD

    Boehringer Ingelheim

    Executive Director, Product Management & Development Operations

    Panelist
    Presenter
    Read Bio
  • Sabrina Restrepo, PhD

    Sabrina Restrepo, PhD

    Merck & Co., Inc.

    Executive Director - Quality Assurance

    Panelist
    Presenter
    Read Bio
  • Bethany B Rexing, MS

    Bethany B Rexing, MS

    Eli Lilly and Company

    M&Q Data Management Director

    Panelist
    Presenter
    Read Bio
  • Dr. Carmelo Rosa

    Dr. Carmelo Rosa

    U.S. FDA

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

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Abriana Rozentsvayg, MA

    Pfizer

    Director Packaging Project Engineering, GTS Packaging and Device SVCS

    Co-Presenter
    Read Bio
  • David Santillan, MBA

    David Santillan, MBA

    Lonza

    Product Manager

    Poster Presenter
    Read Bio
  • Susan J. Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Distinguished Fellow

    Moderator
    Panelist
    Presenter
    Read Bio
  • Kimberly LW Schultz, PhD

    Kimberly LW Schultz, PhD

    U.S. FDA

    GTB CMC Reviewer, CBER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Melissa S. Seymour, MBA

    Melissa S. Seymour, MBA

    Eli Lilly and Company

    EVP and Chief Quality Officer

    Panelist
    Presenter
    Read Bio
  • Pahala Simamora, PhD

    Pahala Simamora, PhD

    U.S. FDA

    Division Director, OPQ, CDER

    Moderator
    Read Bio
  • Steven M Solomon, DVM, MPH

    Steven M Solomon, DVM, MPH

    U.S. FDA

    Director, CVM

    Regulatory Presenter
    Read Bio
  • CDR Emily T Thakur, RPh

    CDR Emily T Thakur, RPh

    U.S. FDA

    Team Leader, CDER

    Regulatory Panelist
    Read Bio
  • Douglas R. Throckmorton, MD

    Douglas R. Throckmorton, MD

    U.S. FDA

    Deputy Director of Regulatory Programs, CDER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Weida Tong, PhD

    Weida Tong, PhD

    U.S. FDA

    Director, Division of Bioinformatics and Biostatistics, NCTR

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Alex M. Viehmann

    U.S. FDA

    Division Director, OPQ, CDER

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • Nicholas A Violand

    Nicholas A Violand

    Johnson & Johnson

    Director, Enterprise Regulatory Compliance

    Regulatory Panelist
    Regulatory Presenter
    Read Bio
  • James C Weber

    James C Weber

    Eli Lilly and Company

    Advisor IT - Digital Manufacturing

    Panelist
    Presenter
    Read Bio
  • Valerie Whelan

    Valerie Whelan

    Thermo Fisher Scientific

    Vice President, Quality

    Co-Chair
    Moderator
    Read Bio
  • David Wolton

    David Wolton

    Takeda

    Engineering Technology Lead

    Panelist
    Presenter
    Read Bio
  • Glenn E. Wright, MA

    Glenn E. Wright, MA

    PDA

    President and CEO

    Panelist
    Read Bio
  • Ravi Yalamanchili, MS, MBA

    Ravi Yalamanchili, MS, MBA

    Merck & Co., Inc.

    Executive Director Global Quality

    Panelist
    Presenter
    Read Bio

Sponsors

Sponsors and Collaborators

Exhibitors

Exhibitors and Innovators
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Tel: +1 (240) 688-4405

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