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2023 PDA FDA JRC

2023 PDA/FDA Joint Regulatory Conference

Sep 18 - Sep 20, 2023
Washington, DC

CGMP: Quality Through Science and Innovation

  • Conference
  • The Americas
Closed
Program Highlights

CDER's Patrizia Cavazzoni, MD and CBER's Peter W. Marks, MD, PhD are confirmed as the opening and closing speakers!

 
Patrizia Cavazzoni
Patrizia Cavazzoni, MD
Director, CDER, U.S. FDA

Peter Marks

Peter W. Marks, MD, PhD
Director, CBER, U.S. FDA
 

Overview

The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 32nd year. This flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. This year's theme is CGMP: Quality Through Science and Innovation.

The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized. Case studies are presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts that improve quality and benefit the consumer are also highlighted.

PROGRAM PLANNING COMMITTEE

  • CAPT Tara Gooen Bizjak, U.S. FDA (Co-Chair)
  • Janeen Skutnik-Wilkinson, Moderna, Inc. (Co-Chair)
  • Denyse Baker, Eli Lilly and Company
  • Paul Balcer, U.S. FDA
  • Hong Cai, U.S. FDA
  • Douglas Campbell, InterPro QRA
  • Christina Capacci-Daniel, U.S. FDA
  • Daniel DeCiero, U.S. FDA
  • Nicole Deschamps, GSK
  • Rebecca Dowd, U.S. FDA
  • Christopher Downey, U.S. FDA
  • Mary Farbman, Merck & Co., Inc.
  • Irving Ford, Adaptimmune
  • Rick Friedman, U.S. FDA
  • Victor (Ray) Gaines, U.S. FDA
  • Marc Glogovsky, ValSource, Inc.
  • Sharyl Hartsock, Eli Lilly and Company
  • Andrew Hopkins, AbbVie Inc.
  • Mai Huynh, U.S. FDA
  • Ingrid Markovic, U.S. FDA
  • Kenneth Nolan, U.S. FDA
  • Jackie Veivia-Panter, BioCentriq
  • Valerie Whelan, Thermo Fisher Scientific
  • Lorraine Wood, U.S. FDA
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Agenda

  • Day 1
  • Day 2
  • Day 3

  • MONDAY, 18 SEPTEMBER

    07:00 – 19:30 | Registration Open
    Beat the Monday morning crowd by picking up your badge on Sunday, 17 September from 14:00 – 19:00!

    07:00 – 08:30 | Continental Breakfast

    08:00 – 10:00 | P1: The Future of Pharmaceutical Quality and Achieving Sustainable Compliance
    Moderator: CAPT Tara Gooen Bizjak, MBS,     Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

    FDA's Director of the Center for Drug Evaluation and Research (CDER), Dr. Patrizia Cavazzoni, will give the opening keynote address at the 2023 PDA/FDA Joint Regulatory Conference. She will share her perspectives on the latest initiatives that continue to advance the quality of drugs and prevent drug shortages, including sustainable compliance via vigilant quality systems and senior management oversight. Following Dr. Cavazzoni, Thermo Fisher Scientific's Machelle Eppler and Michelle Logan will provide insights into the synergy benefits between manufacturing and quality – from robust problem solving and team development, to addressing supply chain and contracting relationships.

    08:00 | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
    Susan J. Schniepp, Chair, PDA Board of Directors and Distinguished Fellow, Regulatory Compliance Associates Inc.
    Glenn E. Wright, President and CEO, PDA
    CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA
    Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.

    08:30 | Call to Action: Assuring Quality Through Sustainable Compliance, Vigilant Quality Systems, and Modern Manufacturing
    Patrizia Cavazzoni, MD,     Director, Center for Drug Evaluation and Research, U.S. FDA

    08:55 | Q&A with Dr. Cavazzoni

    09:10 | Industry Perspectives on The Future of Pharmaceutical Quality and Achieving Sustainable Compliance
    Machelle Eppler,     Group Vice President Pharma Services Group, Thermo Fisher Scientific and Michelle P. Logan, Vice President Drug Product Division North America, Thermo Fisher Scientific

    09:35 | Q&A with Ms. Eppler and Ms. Logan

    10:00 – 10:45 | Networking Break in the Exhibit Area

    10:45 – 12:15 | P2: The Search for Quality and Safety Across Two Realms
    Moderator: Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.

    In aerospace and pharmaceuticals – both complex and highly-regulated industries – safety is paramount. Seeking lessons for the drug industry, the first presenter, Dominic Gates, will discuss the design and quality system failures that led to two tragic Boeing 737 MAX crashes and continuing quality shortfalls in aerospace manufacturing. Just like in the aerospace industry, the importance of design and quality systems to prevent failures and improve operations is also a leitmotif of drug manufacturing. In the second presentation, Toni Manzano will present artificial intelligence (AI) as a useful mathematical tool to monitor a complex wealth of data associated with product and process operations and predict quality "red flags" prior to the manufacture of defective drug product. The presenters will be joined by CDER's Office of Policy for Pharmaceutical Quality Director, Ashley Boam, for a closing panel discussion.

    10:45 | The Devastating Impact of Design and Manufacturing Quality Lapses at Boeing
    Dominic Gates,     Aerospace Reporter, The Seattle Times

    11:10 | AI in Drug Manufacturing: Understanding the Processes from a GxP Perspective
    Toni Manzano, PhD,     Co-Founder and CSO, Aizon and Team Leader, AI in Operations (AIO), AFDO/RAPS Healthcare Products Collaborative

    11:35 | Q&A with Additional Panelist
    Ashley B. Boam, MSBE,     Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, U.S. FDA

    12:30 – 13:30 | Concurrent Interest Group (IG) Sessions
    Grab a boxed lunch and bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!

    IG1: GMP Links to Pharmacovigilance

    • IG Leader: Douglas A. Roepke, MD, Associate Vice President, Lilly Global Patient Safety - Medical - Device and Product Safety, Eli Lilly and Company

    IG2: Quality Risk Management

    • IG Leaders
      • Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
      • Malav Parikh, ME, Director, Global Quality Compliance and Systems, Takeda
    • FDA Co-Facilitators
      • Rick L. Friedman, MS, Deputy Director, OMQ, OC, CDER, U.S. FDA
      • Alex M. Viehmann, Division Director, OPQ, CDER, U.S. FDA (INVITED)

    IG3: Regulatory Affairs

    • IG Leader: Ruhi Ahmed, PhD, RAC, Senior Vice President, FLAG Therapeutics, Inc.
    • FDA Co-Facilitator: Hong Cai, PhD, Division Director, ONDP, OPQ, CDER, U.S. FDA (INVITED)

    13:45 – 15:15 | Concurrent Sessions

    A1: Finding the “C” in CGMP: Building a World Class Quality and Regulatory Intelligence Program
    Moderators: Denyse D. Baker, PE, RAC, Associate Vice President, External Engagement and Advocacy, Global Quality Compliance, Eli Lilly and Company and Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.

    Regulatory guidance and requirements are continuously changing across all markets. Monitoring the environment and ensuring your quality system evolves to meet these new requirements is foundational to product quality. This session will share current best practices about how to integrate newly published regulatory and quality requirements including tools, information management, and communication strategies to help you focus on generating impact assessments and not just cataloging information. This session will also explore what the future of regulatory intelligence and surveillance could look like with the advent of AI, machine learning, chatbots, and advanced analytics technology to optimize your ability to focus on interpretation and implementation not just searching and triage.

    13:45 | Current Best Practices: How to Not Spend All Your Time Searching and Typing
    Denyse D. Baker, PE, RAC,     Associate Vice President, External Engagement and Advocacy, Global Quality Compliance, Eli Lilly and Company

    14:10 | From Spreadsheets to Rocket Ships: What Could Be the Future for Regulatory Intelligence?
    Michael de la Torre, MBA,     Chief Executive Officer, Redica Systems

    14:35 | Q&A with Additional Panelist
    Victor (Ray) Gaines,     Branch Chief, OMQ, OC, CDER, U.S. FDA (INVITED)

    B1: Culture of Communication: Shop Floor to Corporate Oversight
    Moderator: Rebecca E. Dowd, MS, Director, Investigations Branch, Division 3, ORA, U.S. FDA

    Communication, by definition, invariably includes the sharing of information and is fundamental to effective leadership and quality assurance, both within an organization and amongst various external parties. As the workforce of the pharmaceutical industry is comprised of people, an organization's commitment to ensuring effective communication builds the establishment of a mature quality culture and fosters the dissemination and understanding of information. This session will explore the ways in which information sharing via communication can be enhanced and delivered in efforts to increase product quality, operational excellence, and culture. Participants will hear from industry and FDA representatives on the ways to harness effective communication strategies, and example case studies that unearth some of the potential benefits to an organization and resultant quality output to patients.

    13:45 | Culture of Communication: From Shop Floor to Senior Leadership
    Daniel VonDielingen, MBA,     Site Head - Lilly RTP, Eli Lilly and Company

    14:10 | Communications Strategies for the Shop Floor: Fostering Meaningful Peer-To-Peer Communications "In the Flow" of Work
    Martin J. Lipa, PhD,     Principal Consultant, Lipa Group LLC

    14:35 | Q&A with Additional Panelist
    Lauren N. Howard,     Drug Specialist and Pre-Approval Manager, OMPTO, ORA, U.S. FDA (INVITED)

    C1: Supplier Audit Program: Managing Risk, Handling Conflicts, and Assuring Quality
    Moderator: Douglas A. Campbell, Senior Consultant, InterPro QRA

    The obstacles to an effective supplier audit program are well-known and routinely presented at conferences. If you have been involved with a supplier audit program, then it is likely that you have experienced a reluctance to make corrections for audit observations. This session will focus on case studies and insights related to handling conflicts that are generated when there are academic or technical disagreements related to the observations that are documented during an audit. What is the best course of action when your vendor or supplier does not agree with your observation and refuses to develop a corrective action plan? How should the contract-giver document and manage the "regulatory risk" related to the outstanding corrective and preventive action (CAPA)? This session will also address methods to better develop your process for enlightenment and encouragement, while also developing methods for evaluation and assessment of key quality concepts.

    13:45 | Building Supplier Relationships Through Behavior-Based Cultural Excellence
    Tami Frederick,     Senior Director, Corporate Quality Systems and Cultural Excellence, Perrigo

    14:10 | Supply Chain Management Under an Advanced Quality System
    Nicholas A. Violand,     Investigator/Drug National Expert, OMPTO, ORA, U.S. FDA (INVITED)

    14:35 | Q&A

    15:15 – 16:00 | Networking Break in the Exhibit Area

    16:00 – 17:30 | Concurrent Sessions

    A2: Innovations in CGMP Training
    Moderator: Janeen Skutnik-Wilkinson,     Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.

    Do you still conduct training the old-fashioned way by employing "read and understand" (or is that read and forget)? Presenters in this session will discuss what it will take to transform companies into learning organizations and what do we need to do to get there.

    16:00 | Learning Culture in the Digital Age
    Nkiruka Ogbuchiekwe, MEd,     Senior Director, Leadership, Management, and Culture, Moderna University, Moderna, Inc.

    16:25 | Transformational Change in Training
    Nicole King, MBA, Associate Director, GMP Training Transformation, AstraZeneca

    16:50 | Q&A with Additional Panelists
    Paul Z. Balcer,     Program Manager, OMQ, OC, CDER, U.S. FDA
    Vishal Sharma, MS, Cofounder - Director, Vienni Training & Consulting LLP
    David B. Talmage, MBA, Vice President, Education, PDA

    B2: Upgrading and Updating Aging Facilities: Quality and Business Advantages
    Moderator: Christina A. Capacci-Daniel, PhD, Consumer Safety Officer, OMQ, OC, CDER, U.S. FDA

    The "current" in CGMP shifts with contemporary technology and practices in the industry, so that what was once sufficient may no longer be. Whether it is an aging filling suite, veteran site, or newly acquired facility, improvement may be needed to bring manufacturing to contemporary standards. In this session, the presenters will make the case for these small to large-scale changes based on the obvious impact on product quality and the sometimes less obvious but significant business impact of the investment.

    16:00 | Increasing Patient Safety by Implementing Updated Technologies
    Maik W. Jornitz,     Principal Consultant, BioProcess Resources LLC

    16:25 | The Upside of "Current"
    Shelley M. Preslar, MBA,     President and COO, Azzur Training Center Raleigh LLC

    16:50 | Q&A with Additional Panelists
    Rick L. Friedman, MS,     Deputy Director, OMQ, OC, CDER, U.S. FDA (INVITED)
    Erica C. Fullam, MS, Senior Director, Production, GSK
    Karolyn Gale, VP Regulatory Affairs, Emergent BioSolutions

    C2: Supplier Risk Management: Translating Risk Signals into Actions to Sustain Resilient Supply Chains
    Moderator: Nicole Deschamps, PhD, Senior Director, External Development Operations and Process Excellence, GSK

    This session will focus on taking external environmental signals and translating them into action. Presentations will include case studies on how scanning for socio-economic, environmental, and other risks have been used to predict and assess supply chain challenges, drive internal actions, and build resilient supply chains.

    16:00 | Scan, Focus, Act... For Patients
    Eric L. Berg,     Interim Quality Site Head, Amgen Inc.

    16:25 | Grappling with the New Normal: Supplier Risk Management Post-Pandemic
    Dionne Dosa, MHL,     Executive Director, CMC Procurement, Moderna, Inc.

    16:50 | Q&A with Additional Panelists
    Ernest F. Bizjak,     Compliance Officer/Team Leader, OMQ, OC, CDER, U.S. FDA
    Brooke A. Trump, MS,     Director of Quality, External Manufacturing, Large Molecule, GSK

    17:45 – 18:45 | Concurrent Interest Group (IG) Sessions
    Bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!

    IG4: Annex 1 Implementation and GXP Auditing & Inspections

    • Annex 1 Implementation IG Leaders
      • Marcia C. Baroni, MBA, Vice President Enterprise GxP Compliance & Systems, Emergent BioSolutions
      • Gabriele Gori, SVP Global Quality Head and Chief Quality Officer, Biogen
      • Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.
    • GXP Auditing & Inspections IG Leaders
      • Gabriele Gori, SVP Global Quality Head and Chief Quality Officer, Biogen
      • Ghada N. Haddad, PhD, Executive Director, Global Quality Transformation, Merck & Co., Inc.
    • FDA Co-Facilitators
      • Brooke K. Higgins, MS, Acting Branch Chief, OC, CDER, U.S. FDA
      • Timothy J. Pohlhaus, PhD, Consumer Safety Officer, OC, CDER, U.S. FDA

    IG5: Process Validation

    • IG Leaders
      • Robert Dream, Managing Director, HDR Company LLC
      • Mauro Giusti, MSc, Senior Director, Site External Network, Eli Lilly and Company

    IG6: Vaccines

    • IG Leaders
      • Jane L. Halpern, PhD, Executive Director, IAVI
      • Sabrina Restrepo, PhD, Director, Vaccines- Technical Product Leadership, Merck & Co., Inc.
    • FDA Co-Facilitators
      • Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER, U.S. FDA (INVITED)
      • Ingrid Markovic, PhD, Senior Science Advisor, ORO, CBER, U.S. FDA (INVITED)

    19:00 – 22:00 | Grand Opening Reception

  • TUESDAY, 19 SEPTEMBER

    07:00 – 18:00 | Registration Open

    07:00 – 08:30 | Continental Breakfast

    07:15 – 08:15 | Concurrent Breakfast Sessions

    Breakfast 1: Building Quality Science: Insights from St. Gallen's Research
    Moderator: Paul Z. Balcer,     Program Manager, OMQ, OC, CDER, U.S. FDA

    The St. Gallen University presents the latest results from a 2-year research project via a grant funded by U.S. FDA. The St. Gallen team applied advanced machine learning methods deriving the importance of quality management practices with the intent to comply with CGMP requirements. Based on this deeper understanding, St. Gallen University has developed a true excellence model that could help with continuous improvement in drug manufacturing. A member of the FDA team will provide FDA's perspective on the project results.

    07:15 | Building Quality Science: Insights from St. Gallen's Research
    Thomas Friedli, PhD,     Director, Institute of Technology Management, University of St. Gallen

    07:40 | Q&A with Additional Panelists
    Victor (Ray) Gaines,     Branch Chief, OMQ, OC, CDER, U.S. FDA
    Obinna Ugwu-Oju, MS, Division Director, OPQ, CDER, U.S. FDA
    John H. Wan, MBA, Supervisor, OPQ, CDER, U.S. FDA

    Breakfast 2: Contamination Control: A Tabletop Exercise
    Moderator: Sharyl D. Hartsock,     Vice President, US Parenteral Quality, Eli Lilly and Company

    A contamination control strategy (CCS) is not just a document you approve to meet a compliance requirement. The CCS highlights the many contamination control principles that a company establishes as part of a holistic approach to designing, controlling, and evaluating various contamination risks. The success of any one CCS element is intrinsically linked to the others, and the success of the CCS depends upon how well the individual elements work together to reduce the contamination hazards for a specific process. When executed well, the CCS facilitates knowledge management and drives continuous improvement. In this breakfast session, participants will learn about the key elements of a robust contamination control strategy as outlined in PDA's newly approved Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR90). The presenter will guide the audience through a scenario-based case study followed by a session debrief.

    07:15 | Tabletop Exercise Introduction
    Frederic B. Ayers,     Senior Consultant - Microbiology, ValSource, Inc.

    07:25 | Tabletop Exercise

    07:55 | Q&A

    Breakfast 3: Knowledge Management
    Moderator: Marc Glogovsky, MS,     Business Unit Manager/Senior Consultant – Microbiology, ValSource, Inc.

    This interactive session will provide attendees with an update of the work by the PDA Knowledge Management (KM) Roadmap Task Force, including a brief introduction to KM followed by an overview of the team's progress, key insights to date, and planned activities to follow.

    The Task Force will engage the audience to solicit feedback and ideas regarding the proposed roadmap, as well as potential case studies and best practices to uncover, to better understand the needs of industry and of regulatory agencies as this Task Force continues to advance understanding and competency in KM for the industry.

    07:15 | Charting PDA's Path to Advance Knowledge Management
    James L. Vesper, PhD, MPH,     Director, Learning Solutions, ValSource, Inc.

    07:40 | Q&A with Additional Panelists
    Milind Ganjawala, MS, MBA,     Division Director, OC, CDER, U.S. FDA (INVITED)
    Martin J. Lipa, PhD, Principal Consultant, Lipa Group LLC

    Breakfast 4: Continuous Manufacturing and Publication of ICH Q13
    Moderator: Christopher Downey, PhD,     Director, Division of Biotechnology Manufacturing, OPMA, OPQ, CDER, U.S. FDA

    With the implementation of ICH Q13 - Continuous Manufacturing of Drug Substances and Drug Products in 2023, the big question becomes: what barriers to the development of continuous manufacturing processes remain? Advanced manufacturing technology, including continuous manufacturing, has the potential to improve product quality and reliability, lower costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Because of this potential, FDA and others have encouraged and prioritized development of continuous manufacturing. However, so far, the opportunities presented by advanced manufacturing have not yet been realized as significant numbers of applications.

    This session will discuss the remaining challenges in the development and implementation of continuous manufacturing processes now that ICH Q13 is in place. Presenters will offer perspectives and discussion on the technical and regulatory hurdles, both real and perceived, that remain to realizing the potential of continuous manufacturing technology for commercial drugs and biologics.

    07:15 | Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA (INVITED)

    07:40 | Q&A with Additional Panelist
    Christina A. Capacci-Daniel, PhD, Consumer Safety Officer, OMQ, OC, CDER, U.S. FDA (INVITED)

    08:30 – 10:15 | P3: Center Office Updates
    Moderator: Rick L. Friedman, MS,     Deputy Director, OMQ, OC, CDER, U.S. FDA

    The global regulatory landscape is evolving. How will the U.S. FDA continue to optimize its strategies and actions to accomplish its mission to safeguard the quality, safety, and effectiveness of medicines for patients, even with current manufacturing and supply challenges? After introductory presentations on current Center activities, your questions will be posed to executive management from various FDA Centers! In a roundtable format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space.

    08:30 | CBER Updates
    Peter W. Marks, MD, PhD,     Director, CBER, U.S. FDA

    08:45 | CDER Updates
    Jacqueline Corrigan-Curay, JD, MD,     Principal Deputy Center Director, OCD, CDER, U.S. FDA (INVITED)

    09:00 | CVM Updates
    Tracey H. Forfa, JD,     Center Director, CVM, U.S. FDA

    09:15 | ORA Updates
    Carol Cave,     Acting Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA (INVITED)

    09:30 | Q&A

    10:15 – 11:00 | Networking Break in the Exhibit Area

    11:00 – 12:45 | P4: Compliance Office Updates
    Moderator: Janeen Skutnik-Wilkinson,     Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.

    Featuring Office of Compliance leaders from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. In a roundtable format, FDA's top leaders in compliance and enforcement will describe their programs, initiatives, and recent actions related to inspections and compliance. Current regulatory challenges and FDA's current enforcement strategy for a wide array of medical products will be addressed. This is a great opportunity for you to understand FDA's thinking and expectations for industry compliance. In addition, there will be ample time for the audience to ask questions of FDA's senior leadership.

    11:00 | CBER Compliance Updates
    Melissa J. Mendoza, JD,     Acting Director, Office of Compliance and Biologics Quality, CBER, U.S. FDA

    11:15 | CDER Compliance Updates
    Jill Furman, JD,     Director, OC, CDER, U.S. FDA

    11:30 | CVM Compliance Updates
    Cindy L. Burnsteel, DVM,     Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM, U.S. FDA

    11:45 | ORA Compliance Updates
    Alonza E. Cruse,     Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA (INVITED)

    12:00 | Q&A

    13:00 – 14:00 | Concurrent Interest Group (IG) Sessions
    Grab a boxed lunch and bring your comments, questions, and ideas to these interactive IG discussions. Participants will vote on their top discussion topic and then a timed, lively discussion will ensue. When the timer goes off, the group will move on to the next hot discussion topics. IGs are your opportunity to make your voice heard!

    IG7: Biopharmaceutical Manufacturing and Facilities & Engineering

    • Biopharmaceutical Manufacturing IG Leaders
      • Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON Manufacturing, Inc.
      • Toni Manzano, PhD, Co-Founder and CSO, Aizon and Team Leader, AI in Operations (AIO), AFDO/RAPS Healthcare Products Collaborative
    • Facilities & Engineering IG Leader
      • Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC
    • FDA Co-Facilitators
      • Christina A. Capacci-Daniel, PhD, Consumer Safety Officer, OMQ, OC, CDER, U.S. FDA (INVITED)
      • Rebecca E. Dowd, MS, Director, Investigations Branch, Division 3, ORA, U.S. FDA (INVITED)

    IG8: Data Integrity and Technology Transfer

    • Data Integrity IG Leader
      • Kir F. Henrici, Chief Executive Officer, The Henrici Group
    • Technology Transfer IG Leader
      • Beth J. Haas, MChE, Owner/Consultant, Haas Pharma Consulting
    • FDA Co-Facilitators
      • Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, OC, CDER, U.S. FDA (INVITED)
      • Nicholas A. Violand, Investigator/Drug National Expert, OMPTO, ORA, U.S. FDA (INVITED)

    IG9: Pharmacopeial

    • IG Leaders
      • Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services
      • Gina M. Marsee, Director, Compendial Compliance and Advocacy, Merck & Co., Inc.
      • Janeen Skutnik-Wilkinson, Director, Global Quality, Regulatory Surveillance & External Engagement, Moderna, Inc.

    14:15 – 15:45 | Concurrent Sessions

    A3: The New ICH Q9 Guideline: The Next Generation of Quality Risk Management
    Moderator: Rick L. Friedman, MS,     Deputy Director, OMQ, OC, CDER, U.S. FDA

    Earlier this year, a major revision of ICH Q9 Quality Risk Management was published. This internationally harmonized guideline provides invaluable updates relating to lifecycle management of quality risks, based on practical industry and regulatory experience gained with the original guideline. Improved guidance and training materials on minimizing subjectivity, shortage risks, formality, and risk-based decision making, hazard identification and risk reviews. This session will provide insights from the ICH workgroup who prepared the revised guidance, and industry insights on implementation.

    14:15 | Overview of Changes to the ICH Q9R1 Guideline: Critical Evolutions in Risk Management
    Alex M. Viehmann,     Division Director, OPQ, CDER, U.S. FDA

    14:40 | Lifecycle Management of Risks to Ensure an Ongoing State of Control
    Denise M. DiGiulio,     Head of Global Audit and Inspection Management, Genentech

    15:05 | Q&A

    B3: Recently Published Guidances on CGMP and Quality
    Moderator: Victor (Ray) Gaines,     Branch Chief, OMQ, OC, CDER, U.S. FDA

    In this session, participants will learn about recent FDA guidance documents that promote improved CGMP compliance, quality, and protect public health. While guidance documents are not enforceable, they are important tools to provide clarity on compliance issues and they are a mechanism for FDA to publicly comment on, and to provide actionable steps to address compliance and high-risk topics. Presentations will include specific cases, to be followed by an extended panel Q&A.

    14:15 | What’s New in Pharmaceutical Quality (v. 2023)
    Tina Kiang, PhD,     Director, Division of Regulation, Guidance, and Standards, OPPQ, OPQ, CDER, U.S. FDA (INVITED)

    14:40 | Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: FDA Draft Guidance for Industry
    Timothy J. Pohlhaus, PhD,     Consumer Safety Officer, OC, CDER, U.S. FDA (INVITED)

    15:05 | Q&A with Additional Panelist
    J. Kevin Rice, PhD,     CVM Pre-Approval Facilities Assessment Program, ONADE, CVM, U.S. FDA (INVITED)

    C3: Lifecycle Risk Management and CGMP Adaptations to Prevent Nitrosamine Impurity Formation
    Moderator: Hong Cai, PhD,     Division Director, ONDP, OPQ, CDER, U.S. FDA

    The recent unexpected finding of nitrosamine impurities, which are probable human carcinogens, in human drugs has caused a global safety concern for industries, health authorities, and patients and even resulted in batch recalls or delayed marketing for some drugs. This session will discuss the current understanding of the potential root causes of nitrosamine impurities. It will address the important role of CGMP compliance, and the impact of drug components, supply chains, manufacturing facility competencies, ongoing testing, and other quality risk management strategies to detect, prevent, and mitigate nitrosamine impurities in drug products based on sound science for delivery of consistent quality drugs for patients.

    14:15 | Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View
    Sander Van Gessel, MEng,     Business Unit Director, DFE Pharma

    14:35 | A Case Study in Mitigating Nitrosamines Challenges
    Mark Mowery, PhD,     Associate Vice President, Analytical Chemistry in Development and Supply, Merck & Co., Inc.

    14:55 | Milind Ganjawala, MS, MBA, Division Director, OC, CDER, U.S. FDA (INVITED)

    15:15 | Q&A

    15:45 – 16:30 | Networking Break and Passport Drawing in the Exhibit Area

    16:30 – 18:00 | Concurrent Sessions

    A4: Data Integrity: A Key to Innovation
    Moderator: Sharyl D. Hartsock,     Vice President, US Parenteral Quality, Eli Lilly and Company

    The recent release of two FDA discussion papers addressing ML/AI highlights the unique opportunities arising in drug development and manufacturing through application of advanced digital technologies. Rapid, technological leaps in the way we collect, manage, exchange, and analyze data have transformed the data value chain, empowering a seismic shift in the way we create/manage knowledge. Fundamental to enabling data as our most valuable asset is assuring data integrity. With digital transformation, industry has shifted from data integrity compliance to data integrity by-design, adopting data governance principles to integrate data control strategies. This evolution has positioned organizations to proactively seize the ability to harness their data. In this session, presenters will reflect on the data integrity (DI) journey and discuss practical ways where adopting data integrity and governance principles enable organizations to realize data as an empowered asset. The presentations will be followed by a panel discussion with both industry and agency representation.
    16:30 | Data Integrity: Journey from Compliance to Competitive Advantage
    Kir F. Henrici,     Chief Executive Officer, The Henrici Group

    16:55 | Undertaking Data Governance to Enable End-to-End Data Capability
    Andy Clark,     Director, Digital Quality, AbCellera

    17:20 | Q&A with Additional Panelist
    Carmelo Rosa, PsyD,     Division Director, Office of Manufacturing and Product Quality, OC, CDER, U.S. FDA (INVITED)

    B4: PQS Effectiveness: CAPA Effectiveness and Beyond
    Moderator: Andrew D. Hopkins,     Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    This session will begin with an industry presentation highlighting a case study showing a company that has recently been through a large acquisition and the integration of two quality systems. This first talk will include a focus on the processes, pitfalls, and some of the advantages experienced during the acquisition and integration. The second presentation, by U.S. FDA, will address measuring the effectiveness of the pharmaceutical quality system (PQS) from a regulator's point of view and linking back to the ICH Q10 principles. It will also include some of the more common observations regarding PQS effectiveness as well as investigators' best practices to avoid similar issues.

    16:30 | A Tale of Two Quality Systems
    Sean McEwen, MEng,     Vice President Quality Assurance, AbbVie Inc.

    16:55 | PQS Effectiveness is the Open Secret
    CAPT Tara Gooen Bizjak, MBS,     Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

    17:20 | Q&A with Additional Panelist
    Robin Kumoluyi, MS,     Vice President and Chief Quality Officer, Pharmaceuticals, Johnson & Johnson

    C4: Excipients are Drugs, Too!
    Moderator: Mary E. Farbman, PhD,     Associate Vice President, Global Quality Compliance, Merck & Co., Inc.

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines components of drugs as drugs. Excipients, a special class of components, must be manufactured in accordance with Current Good Manufacturing Practice (CGMP), but there are no federal regulations stipulating exactly what this means. In this session, the presenters will review the standards that are applied to excipient manufacturing and how drug product manufacturers can ensure their excipient suppliers provide high quality ingredients. Recent inspection and enforcement trends as well as a case study involving resolution of quality challenges at an excipient supplier through collaboration and communication will also be presented.

    16:30 | Excipient Quality and Recent Cases
    Joseph B. Pham, JD,     Regulatory Counsel, OC, CDER, U.S. FDA (INVITED)

    16:55 | Excipient GMPs and Excipient Production
    Priscilla Zawislak,     Global Regulatory Affairs Advocacy Manager, IFF

    17:20 | Q&A

    18:00 – 21:00 | PDA Capital Area Chapter Reception

  • WEDNESDAY, 20 SEPTEMBER

    07:00 – 15:00 | Registration Open

    07:00 – 08:30 | Continental Breakfast

    07:15 – 08:15 | Concurrent Breakfast Sessions

    Breakfast 5: Data-Driven Approaches to Improving Manufacturing and Quality Systems
    Moderator: Victor (Ray) Gaines,     Branch Chief, OMQ, OC, CDER, U.S. FDA

    Data and metrics drive decisions and manufacturing operations in all types of pharmaceutical and biological firms. Evaluating data in a meaningful way and understanding trends, and other human and process parameters, then acting to improve those processes is critical to meeting quality standards and to improve the overall quality system. Defining useful process metrics and managing the product lifecycle through feedback mechanisms will improve quality. Real-time dashboards and live displays keep production operators and quality personnel updated with the latest information. This session will focus on defining a process and the advanced techniques to establish useful metrics that fit the process and of their outcomes – including production, quality, and how individuals react and act on the data.

    07:15 | Bioprocess Development and Operation in the Digital Age
    Moritz von Stosch, PhD,     Chief Innovation Officer and Board Member, DataHow AG

    07:40 | Q&A with Additional Panelist
    Richard N. Love,     Director of Business Intelligence/Principal, L7 Informatics/HarborView LLC

    Breakfast 6: Fungi 101
    Moderator: Paul Z. Balcer,     Program Manager, OMQ, OC, CDER, U.S. FDA

    There has been a renewed interest and a hot topic as of late in both scientific and entertainment industries about fungi. On our screens, Pedro Pascal and Bella Ramsey are facing the threat of fungal apocalypse in the HBO series, The Last of Us and in the real world, scientists are facing the ever-present threat of potential fungal contamination of pharmaceutical manufacturing facilities. In this session, the presenter will discuss how ubiquitous fungi pose risk to products and patients, the relevance of mold in non-sterile and sterile environments, understanding where the potential blind spots are in microbial contamination, how the presence of fungi in facilities can lead to contaminated products, conducting thorough investigations and CAPA, and effective cleaning and disinfection. Participants will leave this breakfast with a better understand fungus among us.

    07:15 | The Infamous and Misjudged Fungi
    Ziva Abraham, PhD,     CEO, Microrite, Inc.

    07:40 | Q&A with Additional Panelist
    Brooke K. Higgins, MS,     Acting Branch Chief, OC, CDER, U.S. FDA (INVITED)

    Breakfast 7: MRA: The Story So Far and What's Next
    Moderator: Andrew D. Hopkins,     Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

    This breakfast session will highlight how and why the Mutual Recognition Agreement (MRA) came about, including the drivers and the process of assessing capabilities, as well as discuss challenges, next steps.

    07:15 | FDA's Mutual Recognition Agreements: Furthering Our International Collaboration
    Kathleen M. Sinninger, OMPTO International Inspection Liaison, OMPTO, ORA, U.S. FDA (INVITED)

    07:40 | Q&A with Additional Panelists
    Julianne McCullough,     Senior Mutual Recognition Program Officer, OMPTO, ORA, U.S. FDA (INVITED)
    J. Kevin Rice, PhD, CVM Pre-Approval Facilities Assessment Program, ONADE, CVM, U.S. FDA

    Breakfast 8: Cells to Sales: Ensuring Quality in the Cell Therapy Terrain
    Moderator: Irving Ford, MSc,     VP of Quality, Adaptimmune

    The journey from clinical to commercial for cell therapies can be challenging. Many manufacturing and regulatory roadblocks, detours, and setbacks may be encountered on the way to the destination. If this is a journey for which you have or planned to embark, this session is just for you. Attend this breakfast to hear from an experienced guide who will help you navigate the best possible routes to bypass and avoid many of the barriers encountered by those who have successfully conquered the journey.

    07:15 | Successfully Navigating Global Cell Therapy Requirements
    Humberto Vega, PhD,     Executive Director, Bristol Myers Squibb

    07:40 | Q&A

    08:30 – 10:00 | P5: Current GMP Compliance Trends and Topics
    Moderator: Douglas A. Campbell,     Senior Consultant, InterPro QRA

    This "can't miss" session will include presentations from CDER and CBER and will provide more than just the "Top Ten 483 observations." Participants will gain an understanding of the most recent trends from violative inspections and enforcement actions. This session routinely provides several key topics for attendees to consider and take back for discussion with their team members and colleagues.

    08:30 | CDER Update
    Francis RW Godwin, MBA,     Office Director, OMQ, OC, CDER, U.S. FDA

    08:55 | CBER Compliance Update
    Daniel DeCiero,     Consumer Safety Officer, OCBQ, CBER, U.S. FDA

    09:20 | Q&A with Additional Panelists
    Marea K. Harmon, Consumer Safety Officer, OSC, CVM, U.S. FDA
    Barbara J. Wilimczyk-Macri, MS, Senior Compliance Officer, OMPTO, ORA, U.S. FDA (INVITED)

    10:00 – 10:45 | Networking Break

    10:45 – 12:15 | Concurrent Sessions

    A5: Quality and Efficiency: Achieving Both Through Process Knowledge
    Moderator: Daniel DeCiero,     Consumer Safety Officer, OCBQ, CBER, U.S. FDA

    The process knowledge that comes from process validation is often thought of as being useful for quality only. A deep knowledge of your process can also be used to improve efficiency while maintaining or improving quality. In this session, participants will learn the fundamentals of process validation principles along with real-world examples of using process validation knowledge to improve quality and efficiency.

    10:45 | Process Validation: Getting the Full Picture
    Brooke K. Higgins, MS,     Acting Branch Chief, OC, CDER, U.S. FDA (INVITED)

    11:15 | Process Validation for CAR-T Products: A Continuous Journey
    Bassem Gayed, PhD,     Senior Technical Director, CAR-T Process Engineering, Manufacturing Science & Technology, Bristol Myers Squibb

    11:45 | Q&A

    B5: Revisiting Investigation Specialization: Building a World Class Investigation Process/Program
    Moderator: Valerie Whelan,     Vice President, Quality, Thermo Fisher Scientific

    Significant events in our industry rarely have a single cause. Rather, they are initiated by the unexpected interaction of multiple small, seemingly unimportant human errors, technology failures, or bad decisions combined with enabling conditions to produce the event. Becoming normalized to these latent errors remains the single biggest risk we face every day. In this session, participants will learn how some companies are driving culture changes to drive greater action on these latent errors, build world class investigation programs, and avoid disasters.

    10:45 | Does Your Problem-Solving Strategy Increase Anxiety and Leave Users Feeling Overwhelmed?
    Sophia Finckbone,     Deviations & CAPA Global Process Owner, GSC Quality, GSK

    11:10 | Barbara J. Wilimczyk-Macri, MS, Senior Compliance Officer, OMPTO, ORA, U.S. FDA (INVITED)

    11:35 | Q&A

    C5: Managing Suppliers' Corrective and Preventive Actions
    Moderator: Mai X. Huynh, MS,     Supervisory Chemist, ONADE, CVM, U.S. FDA

    This session will address the roles of owner(s) and supplier(s) for ensuring compliance with CGMP for the manufacturing activities it performs. A case study will be presented to include the implementation of supplier's oversight over the manufacture of drugs, in particular when a Corrective and Preventive Action (CAPA) plan or change controls are initiated. The role of the owner and supplier or contract facility in managing the risk of the implementation of proposed CAPAs will be discussed, including documentation of actions, findings, and/or changes to the CAPA plan and the communication that should occur to allow effectiveness measurements of such actions.

    10:45 | Effective CAPA Management Through Supplier Oversight
    Bina Nair,     Vice President, Operations Compliance Readiness, Pfizer Global Supply, Pfizer

    11:10 | Don't Jump to Conclusions: Ensuring Effectiveness of Supplier CAPAs
    Philippe de Vilmorin,     Head of Materials Science, Biogen

    11:35 | Q&A with Additional Panelists
    Kristen L. Anderson, PhD,     Microbiologist, ONADE, CVM, U.S. FDA (INVITED)
    Nicholas A. Violand, Investigator/Drug National Expert, OMPTO, ORA, U.S. FDA (INVITED)

    12:30 – 13:30 | Lunch with the Regulators
    Moderators: Rebecca E. Dowd, MS,     Director, Investigations Branch, Division 3, ORA, U.S. FDA and Mary E. Farbman, PhD, Associate Vice President, Global Quality Compliance, Merck & Co., Inc.

    Grab your boxed lunch and bring questions for U.S. FDA investigators, reviewers, and compliance officers to this Q&A session that will allow for direct input and will provide you with insights regarding inspection trends and center initiatives.

    PANELISTS
    Brooke K. Higgins, MS,     Acting Branch Chief, OC, CDER, U.S. FDA
    Laura S. Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, CVM, U.S. FDA
    Anthony F. Lorenzo, Branch Chief, OCBQ, CBER, U.S. FDA
    Nicholas A. Violand, Investigator/Drug National Expert, OMPTO, ORA, U.S. FDA (INVITED)

    13:45 – 14:45 | P6: Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies
    Moderator: Ingrid Markovic, PhD,     Senior Science Advisor, Immediate Office of Regulatory Operations, CBER, U.S. FDA

    Cell and gene therapy (C&GT) is a rapidly expanding field offering to deliver curative therapies for many diseases including some rare and ultra-rare conditions. Scientific discovery has been essential to overcoming common challenges resulting from uniquely individualized approaches, associated logistics, and post Covid-related complexities. With growing numbers of regulatory submissions worldwide, innovation in this area has driven changes across the biopharmaceutical sector. This closing plenary will feature world leaders sharing their thoughts on how the field utilizes scientific discovery and innovation to mitigate manufacturing speed bumps, overcoming some of the common pitfalls to achieve robust quality for patients, and streamlining patient access to safe and effective C&GTs.

    13:45 | Turning Genes Into Medicines: Scientific Advances Fueling Product Development
    Katherine High, MD, Visiting Professor, Allen and Frances Adler Laboratory of Blood and Vascular Biology, The Rockefeller University

    14:05 | CAR T Cells: Living Drugs for Immunotherapy
    Michel Sadelain, MD, PhD,     Director, Center for Cell Engineering; Stephen and Barbara Friedman Chair, Memorial Sloan Kettering Cancer Center

    14:25 | Accelerating the Pace of Gene Therapy Development for Rare Diseases
    Peter W. Marks, MD, PhD,     Director, CBER, U.S. FDA

    14:45 | Q&A

    15:10 | Closing Remarks from Conference Co-Chairs

Networking Opportunities

MONDAY, 18 SEPTEMBER

  • 10:00 – 10:45 | Break in the Exhibit Area
  • 15:15 – 16:00 | Break in the Exhibit Area
  • 18:45 – 22:00 | Grand Opening Celebration

TUESDAY, 19 SEPTEMBER

WEDNESDAY, 20 SEPTEMBER

  • 10:00 – 10:45 | Break

Highlighted Speakers

CAPT Tara Gooen Bizjak
CAPT Tara Gooen Bizjak
U.S. FDA
Alonza E. Cruse
Alonza E. Cruse
U.S. FDA
Machelle Eppler
Machelle Eppler
Thermo Fisher Scientific
Dominic Gates
Dominic Gates
The Seattle Times
Katherine High
Katherine High
The Rockefeller University
Michelle P. Logan
Michelle P. Logan
Thermo Fisher Scientific
Toni Manzano
Toni Manzano
Aizon and AFDO/RAPS Healthcare Products Collaborative
Michel Sadelain
Michel Sadelain
Memorial Sloan Kettering Cancer Center
View All

Additional Information

  • Who Should Attend
    Departments
    • Corporate Offices, Research and Development
    • Regulatory Affairs
    • Manufacturing
    • Quality Assurance/Control
    • Marketing
    • Sales
    Job Function
    • Quality Assurance
    • Manufacturing
    • Compliance/Inspection Management
    • Supply Chain
    • Auditing
    • Executive Management
    Academia
    • Pharmaceutical sciences
    • Regulatory science
    Global Regulatory Authorities

Got a Question? We have answers

Contact Us

Livestream

Conference
Elements		 In-Person
Attendance		 Livestream
Attendance
Plenary Sessions Yes Yes
Concurrent Sessions Yes Yes
Breakfast Sessions Yes Select sessions with audio only
Ability to Submit Questions for Q&A Yes Yes
Lunch with the Regulators Yes Yes
Interest Group Discussions with FDA Participation Yes No
Exhibit Hall Yes No
Monday Evening Networking Reception Yes No
In-Person Networking with Industry and Regulatory Participants, Presenters, and Panelists Yes No

Travel

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.

Renaissance Washington, DC Downtown

999 9th Street, NW
Washington, DC

Make a Reservation
Renaissance Washington, DC Downtown
  • Accommodations
    The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA/FDA Joint Regulatory Conference!

    The Conference hotel room block is closed. We recommend calling the Renaissance for reservations or booking online for the best available rate.

    Reservations

    Phone: +1 (202) 898-9000
    Online:     Click on the reservation link above

  • Amenities
    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. From museums to entertainment, this is the perfect base for exploring downtown DC. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi. Steps from shopping, dining, nightlife and sports, this hotel places the best of DC at your doorstep. Expect the extraordinary at Renaissance Washington, DC Downtown Hotel.

How to Get Here

By Air

The airports closest to the Renaissance Washington, DC Downtown hotel are Reagan National Airport (DCA, 4.6m/7.4km), Dulles International Airport (IAD, 27.8m/46.2km), and Baltimore-Washington International Airport (BWI, 32.1m/51.7km).

By Car

The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($35+/day) and valet parking ($61+/day) are available.

Other Options

The metro stations closest to the Renaissance Washington, DC Downtown hotel are Mount Vernon Square (yellow/green line, 0.4m/0.6km), Gallery Place (red/yellow/green, 0.3m/0.5km), and Metro Center (red/blue/orange/silver, 0.4m/0.6km). Please visit www.wmata.com for fare and schedule information.

Directions

Registration Fees

Early Registration
Registration Type By 23 July
In Person OR Livestream
Member $2,395
Non-Member $2,795
Gov./Health Authority/Academic (Member Only) $795
Student (Member Only) $495
Early Career Professional (Member Only) $1,295
Regular Registration
Registration Type After 23 July
Livestream 		After 23 July
In Person
Member $2,395 $2,895
Non-Member $2,795 $3,295
Gov./Health Authority/Academic (Member Only) $795 $895
Student (Member Only) $495 $595
Early Career Professional (Member Only) $1,295 $1,395

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].

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    Tel: +1 (301) 656-5900 ext. 132
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