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2022 PDA/FDA Joint Regulatory Conference

Sep 12 - Sep 14, 2022
Washington, DC

Quality Evolution/Technology Revolution: Modern Quality Management Solutions

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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 31st year. This flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. 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.


  • Day 1
  • Day 2
  • Day 3
  • Monday, 12 September

    08:00 – 10:00 | P1: Looking to the Future
    Moderator: Valerie Whelan,
    Vice President Quality, Drug Substance Division, Thermo Fisher Scientific

    Dr. Peter Marks, FDA’s Director of the Center for Biologics Evaluation and Research, will kick-off the 31st PDA/FDA Joint Regulatory Conference with a presentation on the synergies between science, compliance, quality, and facility capabilities. The second presenter is Susan Hynes, the Senior Vice President of Global Supply Chain Quality at GSK. The presenters will emphasize the bright future ahead of us afforded by adopting and committing to good practices in product development, quality systems, and manufacturing performance throughout the lifecycle.

    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.
    Richard M. Johnson, MSc, President and CEO, PDA  
    Rick L. Friedman, MS, Co-Chair, PDA/FDA Joint Regulatory Conference and Deputy Director, OMQ, CDER, U.S. FDA
    Valerie Whelan, Co-Chair, PDA/FDA Joint Regulatory Conference and Vice President Quality, Drug Substance Division, Thermo Fisher Scientific

    08:30 | Emerging from Covid: An FDA Perspective
    Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA

    08:55 | Emerging from Covid: An Industry Perspective
    Susan Hynes, MA, Senior Vice President, GSC Quality, GSK

    09:25 | Q&A

    10:00 – 10:45 | Refreshment Break in Exhibit Area

    10:45 – 12:15 | P2: What Does Sustainable Compliance Look Like?
    Moderator: Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA

    This session will address why maintaining compliance with FDA requirements is so important and in the best interests of both manufacturers and patients. Presentations will provide insights into key attributes in organizations that maintain sustainable compliance, including how knowledge-driven systems and a quality assurance foundation lead to durable solutions to complex problems. The patient and business benefits of a persistent focus on a preventive (the “P” in CAPA) mindset throughout operations will be explored. The presenters will ultimately describe how this systemic approach to compliance creates the lifecycle vigilance and adaptability that provides the foundation for consistent quality and supply.

    10:45 | Sustainable Compliance
    Donald D. Ashley, JD, Director, Office of Compliance, CDER, U.S. FDA

    11:10 | Juan Andres, Chief Technical Operations and Quality Officer, Moderna, Inc.

    11:35 | Q&A with Additional Panelist
    Francis RW Godwin, MBA,
    Office Director, CDER, U.S. FDA

    12:30 – 13:30 | Concurrent Interest Group (IG) Sessions

    13:45 – 15:15 | Concurrent Sessions

    A1: How Effective Is Your GMP Training?
    Moderator: Paul Z. Balcer, Program Manager, CDER, U.S. FDA

    Training programs in industry vary in their design but all are intended to meet the CGMP requirement to ensure employees are qualified for their job function. The routine ongoing training program is also often accompanied by ad hoc retraining when a failure is attributed to them. Yet truly effective CAPA should normally include mistake-proofing and not solely stop with retraining an operator. Rethinking training may include adding competencies such as investigations, CAPA, root cause analysis, and design thinking to ensure a set of specialized personnel are able to create resilient solutions by improving systems and design, whenever needed, to prevent recurrence of problems. In this session, we will examine the key features of an effective GMP training program that builds the foundation for GMP compliance and improving training programs and strategies to better support robust quality assurance and state of control.

    13:45 | Human Error = Equipment Failure
    Jim Vesper, 
    Director, Learning Solutions, Valsource, LLC

    14:10 | After You Rule Out Human Error...
    Tracie H. Sharp, MHA, Branch Chief, OC, CDER, U.S. FDA

    14:35 | Q&A

    B1: Speed vs. Quality: Advantages and Pitfalls of Just-In-Time Manufacturing
    Moderator: Valerie Whelan, Vice President Quality, Drug Substance Division, Thermo Fisher Scientific

    How often have you found yourself in a fire fighting situation with a project, a lot/batch, a customer audit or inspection where you are doing a significant clean up after the fact with a situation that could have been avoided if there had been a greater willingness to slow down, design, and plan properly before you started?

    As the intensity within our industry and focus on speed-to-market for new therapies continues to increase, the natural inclination is to just try to go faster when, in reality, we need to “go slow to go fast.”

    In this session, presenters will leverage case studies from industry to demonstrate the value of taking this type of approach versus one focused on speed and share examples from the regulator’s perspective on how robust planning helps ensure success.

    13:45 | Haste Makes Waste: Lessons Learned for How to Avoid a Crisis
    Douglas A. Campbell,
    Senior Consultant, InterPro QRA

    14:10 | Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA (INVITED)

    14:35 | Q&A

    C1: Recently Published Guidances on CGMP and Quality
    Moderator: CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    New policy, guidance, procedures, oh my! FDA has published many new documents over the past year. In this all-FDA presenter session, participants will hear a high-level overview about new quality guidance. Presentations will also include a case-related dive into the draft Guidance for Industry on Inspection of Injectable Products for Visible Particulates (Dec 2021), to be followed by a multi-center panel Q&A.

    13:45 | Tina Kiang, PhD, Director, Division of Regulation, Guidance, and Standards, CDER, U.S. FDA (INVITED)

    14:10 | Timothy J. Pohlhaus, PhD, Consumer Safety Officer, OC, CDER, U.S. FDA

    14:35 | Q&A with Additional Panelists
    CDR John W. Diehl, MS, Director, Chief, Medical Products and Tobacco Policy Branch, ORA, U.S. FDA (INVITED)
    J. Kevin Rice, PhD, CVM Facilities Assessment Program, CVM, U.S. FDA
    Anita F. Richardson, MAS, Associate Director for Policy, OCBQ, CBER, U.S. FDA

    15:15 – 16:00 | Refreshment Break in Exhibit Area

    16:00 – 17:30 | Concurrent Sessions

    A2: Human Error: Effectively Resolving the Most Common Cause of Quality Failures
    Moderator: Rosemary Orciari,
    Director of Quality Operations, Advanced Manufacturing, Pfizer

    Human error is the most common reason for manufacturing quality failures, but we often stop at addressing this symptom rather than addressing the actual root causes. In this session, practical presentations will detail why training alone is not the answer to human error reduction. Real-life examples will address the roles of risk analysis, process performance monitoring, CAPA, digital tools and continual improvement in minimizing human error and its impact.

    16:00 | Training Won't Fix This
    Kenneth A. Whitehead,
    Vice President - Global Manufacturing Services, Eli Lilly and Company

    16:25 | Human Error in GMP: A Regulator's Perspective
    Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

    16:50 | Q&A with Additional Panelist
    Leah M. Randall,
    Deviation Manager, AstraZeneca

    B2: The Digital Automation Revolution: Implementation and Validation
    Moderator: Mike G. Labruto, MS, Executive Director, Quality Assurance, Gene Therapy Program, University of Pennsylvania

    Appropriate use of data is critical throughout process development; it helps inform a firm's lifecycle problem recognition, control strategy improvements, risk evaluations, and CAPAs. In this session, participants will hear how the use of artificial intelligence (AI) has been applied within the biopharm process validation stages. The validity and efficiency of the analytical methods employed during the continued process validation (CPV) require extensive knowledge of the process. The challenge for new processes exists as there is limited knowledge available. This will include a case study demonstrating the suitability of methods based on machine learning/artificial intelligence (ML/AI) for the CPV applied across a 5L bioprocess monitoring program and demonstration of cell physiological control. The case study will also include examples and considerations for managing AI using quality systems to ensure the integrity of the data is properly controlled.

    The second presentation will highlight the aspects of data controls within PDA Technical Report No. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations, including the importance of data criticality. It will also provide recent data from observations related to data integrity/management from recent inspections.

    16:00 | Evolution of Biopharma Processes Rely upon Robust Data Quality: Case Study on Usage of AI in Continued CPV
    Toni Manzano,
    Chief Security Officer, Aizon

    16:25 | Agency’s View on Data Criticality and Control Mechanisms to Support Data Integrity Program, Including Recent Data Integrity Observations
    Rebecca Parrilla,
    Consumer Safety Officer, OC, CDER, U.S. FDA

    16:50 | Q&A

    C2: Building Quality into Complex Drug Products
    Moderator: Bing Cai, PhD, Division Director, CDER, U.S. FDA

    This session will focus primarily on building quality into the drug product development throughout the lifecycle management, including product development, manufacturing process design, and quality controls, with tools of risk assessment of critical quality attributes (CQAs) and assurance of reliable supply chain. During this session, participants will learn how this strategy is used for complex drug products and novel continuous manufacturing process features, real-time process control strategy, including rapid assessment of process parameters and material attributes, and adequate control of the product quality and performance. Participants will also learn how to achieve commercial quality readiness and sustainable production with the establishment of a reliable supply chain and business continuity planning.

    16:00 | Continuous Manufacturing of Liposomes and Lipid Nanoparticles: Control Strategy on the Product Quality
    Tony Costa, PhD, Chief Executive Officer, DIANT Pharma Inc.

    16:25 | Drug Product Development Technical Review and Stage Processes and the PAI Connection
    Eric Thostesen, Senior Director, Regulatory Compliance, Johnson & Johnson

    16:50 | Q&A with Additional Panelists
    Arwa El Hagrasy, PhD,
    Associate Director, Regulatory Affairs (CMC), Alnylam Pharmaceuticals
    Peter Wojciechowski, PhD,
    Knowledge Management, Technical Development, Moderna, Inc.

    17:45 – 18:45 | Concurrent Interest Group (IG) Sessions

    19:00 – 22:00 | Grand Opening Reception

  • Tuesday, 13 September

    07:15 – 08:15 | Concurrent Breakfast Sessions

    Breakfast 1: Digital Twins
    Moderator: Nicole Deschamps, PhD, Product Quality Director, GSK

    In this session, participants will gain a fundamental understanding of what digital twins are and an appreciation of their power in accelerating process development, ensuring robust production, and improving quality.

    07:15 | Impact and Potential of Digital Twins in The Development and Launch of Medicines and Vaccines
    Matt Harrison,
    Vice President, Projects & Digital Sciences, GSK

    07:40 | Q&A

    Breakfast 2: GMP at a Distance: The Present and The Future of Remote Regulatory Assessments
    Moderator: Ekaterina Allen, Consumer Safety Officer, CBER, U.S. FDA

    Are you wondering if your facility is a good candidate for a remote regulatory assessment (RRA)? Want to learn more about different types of approaches regulators use or the best ways to prepare for them? Curious if you should even care about RRAs, now that travel has largely resumed? These questions (and more!) will be addressed in this session where participants will discuss the lessons learned from two years of using this regulatory tool and its utility in the post-pandemic world.

    07:15 | Susan Laska, MS, Deputy Chairperson, Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Deputy Assistant Commissioner, OMPTO, ORA, U.S. FDA (INVITED)

    07:40 | Q&A with Additional Panelists
    Milind Ganjawala, MS, MBA, Division Director, CDER, U.S. FDA
    Priscilla María Pastrana López, Consumer Safety Officer, ORA, U.S. FDA (INVITED)

    Breakfast 3: Using Audit Observations to Predict Problems
    Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    Supplier audits, self-audits, regulatory audits, and client audits are all part of any company’s audit program. The normal reaction to observations related to audits is to respond to the auditor with the actions taken to correct the noted observation. The question is: Can we also use the collective observations to try and predict problems that may result in down time, quality issues, or, at worst, drug shortages? This session will explore how to use all the information from the various audits as a predictive tool for potential problems as a part of a comprehensive quality risk management program.

    07:15 | Panel Discussion
    Bob Buhlmann,
    Head of Quality Digital Systems, AstraZeneca
    CDR John W. Diehl, MS,
    Chief, Medical Products and Tobacco Policy Branch, ORA, U.S. FDA (INVITED)
    Valerie Whelan,
    Vice President Quality, Drug Substance Division, Thermo Fisher Scientific

    Breakfast 4: Got 483?
    Moderator: Jay Jariwala, Senior Director, Regulatory Compliance, Sidley Austin LLP

    After receiving an FDA Form 483, Inspectional Observations (FDA-483) companies may wonder, “How should I respond? What should a response contain? How does it affect FDA’s decision making?” In this session, participants will learn what a firm should do after receiving FDA-483 as well as what steps firms should take, including importance of a closeout meeting, how to analyze observations, elements of an effective response, and the importance of responding to verbal observations.

    07:15 | The FDA-483: History, Law, and Policy Perspectives
    David L. Chesney, MSJ, 
    Principal and General Manager, DL Chesney Consulting, LLC

    07:40 | Q&A with Additional Panelist
    CAPT Tara Gooen Bizjak, MBS,
    Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    08:30 – 10:15 | Plenary 3: Center Office Updates
    Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    The global regulatory landscape is evolving, and innovative approaches to product life cycle and quality paradigms are met by new real-life challenges and complexities every day – patient-individualized medicines, supply challenges for legacy products, transition to new technologies, highly globalized supply chains. How will the U.S. FDA continue to optimize its mission to safeguard the quality, safety, and effectiveness of medicines for patients even with these manufacturing and supply challenges? After introductory presentations, your questions on these and other issues will be posed to FDA 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, CDER, U.S. FDA

    09:00 | CVM Updates
    Steven M. Solomon, DVM, MPH, Director, CVM, U.S. FDA

    09:15 | ORA Updates
    Judith A. McMeekin, PharmD, Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA

    09:30 | Q&A

    10:15 – 11:00 | Refreshment Break in Exhibit Area

    11:00 – 12:45 | Plenary 4: Compliance Office Updates
    Moderator: Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck – Co., 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 inspection and compliance. Current regulatory challenges and FDA’s current enforcement strategy for a wide array of medical products will be addressed. This is the best possible opportunity for you to understand FDA’s thinking and expectations for industry compliance. Most importantly, 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, Deputy Director, Office of Compliance and Biologics Quality, CBER, U.S. FDA

    11:15 | CDER Compliance Updates
    Donald D. Ashley, JD, Director, Office of Compliance, 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 and Inspectional Activity Updates
    Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA

    12:00 | Q&A

    13:00 – 14:00 | Concurrent Interest Group (IG) Sessions

    14:15 – 15:45 | Concurrent Sessions

    A3: Warning Letters and Consent Decree: How to Avoid Them by Staying in Compliance
    Moderator: Denise M. DiGiulio, Senior Director, Johnson & Johnson

    Are you struggling with an uptick of quality problems and regulatory scrutiny; challenges that can lead to costly regulatory consequences such as a warning letter or worse yet a consent decree? As companies’ product portfolios have become more complex and supply chains more global, regulators have heightened concerns about patient safety, product quality, and drug shortages. This session will discuss insights into preventing the conditions that result in regulatory actions, and why this is far better than reactive and costly remediation. We will leverage a case study from industry to demonstrate a proactive approach to managing quality and compliance risks. An experienced quality executive will share their knowledge, experience, and lessons learned in the remediation of several consent decrees and warning letters. Both topics will demonstrate how putting quality first helps senior leadership transform the quality culture to establish and sustain quality and CGMP compliance for the long haul.

    14:15 | Consent Decree Remediation Success, A Sustainable Quality System
    Ron Branning, MBA,
    Chief Executive Officer, GXP Quality Systems, LLC

    14:40 | Compliance Premediation
    Mary E. Farbman, PhD,
    Executive Director, Global Quality Compliance, Merck & Co., Inc.

    15:05 | Q&A with Additional Panelists
    Peter E. Baker, MS,
    President, Live Oak Quality Assurance
    Carmelo Rosa, PsyD,
    Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

    B3: Innovative Manufacturing: Pathways to Implementation for Biologics and Biotech
    Moderator: Denyse D. Baker, PE, RAC, Senior Director of Global Regulatory Policy, AstraZeneca

    The scope of innovative manufacturing can be so much more than continuous processing of tablets. Come to this session for an interactive opportunity to learn about successfully bringing new technology into your biologics and biotech manufacturing operations including gaining regulatory acceptance. Experts will discuss how industry can have early interactions with their CBER Advanced Technology Team (CATT) to de-risk the implementation of advanced technologies, including case studies, and how they are supporting the adoption of new technology through extramural research. Then, the head of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) will share case studies on how the institute is partnering with industry and academic institutions to enable and encourage the adoption of new technology and overcome perceived barriers.

    14:15 | The CBER Advanced Technologies Team (CATT): Promoting the Adoption of Advanced Manufacturing Technologies
    Manuel Osorio, PhD,
    Senior Scientist for Emerging Technologies and Medical Countermeasures, CBER, U.S. FDA

    14:40 | Accelerating Manufacturing Innovation: Shared Understanding and Going First Together 
    Kelvin H. Lee, PhD,
    Institute Director,  National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL)

    15:05 | Q&A with Additional Panelist
    Lily Y. Koo, PhD,
    Biomedical Engineer, CBER, U.S. FDA

    C3: Contamination Control Strategy: It’s Just Good Business
    Moderator: Sharyl D. Hartsock, Senior Director Quality, Global Quality Systems, Eli Lilly and Company

    The Annex I update has gone through multiple sets of industry review, comment, and revision. One aspect that has remained constant through those updates is the requirement for implementation of a contamination control strategy (CCS). This session will focus on key elements of CCS and highlight how robust application serves as a competitive advantage within the industry. Both agency and industry microbiologists will discuss critical prevention and detection controls to minimize microbial and particulate risk along with an evaluation of effectiveness as part of an overall program aimed at driving continuous improvement. They will also discuss how the CCS enables rapid detection of an issue that may be investigated quickly, to prevent product contamination, in accordance with PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry.

    14:15 | Contamination Control Strategy: Case Study on Microbiological Application
    Frederic B. Ayers,
    Advisor - Global Quality Systems, Eli Lilly and Company

    14:40 | Innovative Technologies to Support Contamination Control Strategies
    Maik W. Jornitz, MSEng,  
    President and CEO, G-CON Manufacturing

    15:05 | Q&A with Additional Panelists
    Thomas J. Arista,
    Consumer Safety Officer, ORA, U.S. FDA (INVITED)
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA

    15:45 – 16:30 | Refreshment Break in Exhibit Area

    16:30 – 18:00 | Concurrent Sessions

    A4: Pre-Approval Inspections: Facility Deviations, Findings, and FDA 483 Responses
    Moderator: Paresma R. Patel, Supervisory Chemist, CDER, U.S. FDA

    In this session, participants will gain familiarity with prior approval inspections and tools utilized by FDA to assess manufacturing facilities, including remote evaluation. An industry case study will be presented along with lessons learned with respect to FDA’s risk-based prior approval inspections of manufacturing facilities.
    16:30 | PAI Findings
    Nicole Oliynyk,
    Executive Director Regulatory Affairs, Ocular Therapeutix

    16:55 | PAI Case Study
    Madushini N. Dharmasena,
    Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

    17:20 | Q&A with Additional Panelists
    Michele L. Obert, Pre-Approval Manager, ORA, U.S. FDA
    Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, CDER, U.S. FDA

    B4: How ICH Enables Modernization and Innovation
    Moderator: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA

    International Council for Harmonisation (ICH) has a key role in promoting regulatory convergence of quality standards. Rapid advancements in science and technology, expanding global markets, and the onset of the pandemic underscored the need for convergence working in sync with continuous improvement and innovation, mitigating supply chain vulnerabilities, and enabling patient access to breakthrough therapies.

    This session will discuss how ICH helps enable modernization and innovation viewed through the lens of the quality discussion group (QDG). QDG reinforced holistic views of quality risk management and science accommodating advanced technologies and approaches such as automation, isolation, digital technology, AI, modeling, knowledge management through data clouds and structured data formats, portable manufacturing, etc., across ICH quality guidelines and therapeutic modalities.

    The session will also discuss current perspectives on ICH Q12 implementation, with a goal of facilitating utilization and realizing the benefits of enhanced science, controls, and quality systems in streamlining post approval change implementation.

    16:30 | ICH QDG 2022: Global Harmonization via Improved ICH Implementation
    Roger Nosal, MA, Vice President, GCMC, Pfizer

    16:55 | FDA Perspective on ICHQ12 Implementation
    Mahesh R. Ramanadham, PharmD, MBA,
    Associate Director Scientific Operations, CDER U.S. FDA

    17:20 | Q&A with Additional Panelists
    Frank Montgomery, PhD,
    Vice President CMC RA, AstraZeneca
    Kevin J. O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

    C4: Managing External Suppliers: Complexities and Knowledge Management
    Moderator: Jay Jariwala, Senior Director, Regulatory Compliance, Sidley Austin LLP

    Globalization and the need for manufacturing flexibility have given rise to use of external suppliers and contract manufacturing organizations (CMOs) throughout pharmaceutical manufacturing.  The use of CMOs comes with practical risks. Effective governance sees sourcing and managing CMOs as a win-win approach where the benefit of all stakeholders is considered, providing a strategic partner that shares the same quality and patient safety values, rather than a transactional focus. As such, a distributed supply chain amplifies the need for vigilance that ensure that quality exercises throughout the product lifecycle. This session will focus on areas that are essential in cultivating a strong, agile, and sustainable ecosystem of CMOs: a smart supply chain, communication and collaboration to avoid data silos, a strong governance structure, risk management, and data-driven and quality-focused metrics and analytics. Presenters will also discuss strategies firms should consider during selection, managing lifecycle risks, and paradigm shift with strategies and integrated use of highly capable technology for ongoing assurance due to physical supplier audit limitations.

    16:30 | Your Suppliers' Risk Is Your Risk: Things to Consider While Developing a Robust Supplier Management Program
    Ernest F. Bizjak, 
    Compliance Officer/Acting Team Leader, OMQ, CDER, U.S. FDA

    16:55 | Data Driven Supplier Knowledge: Management and Governance
    Lisa Gibson,
    Director of QA – New Site Integration, Thermo Fisher Scientific

    17:20 | Q&A with Additional Panelist
    Brooke K. Higgins, MS,
    Senior Policy Advisor, CDER, U.S. FDA
  • Wednesday, 14 September

    07:15 – 08:15 | Concurrent Breakfast Sessions

    Breakfast 5: Reinventing the Efficiency and Reliability of the Microbiology Lab
    Moderator: Sharyl D. Hartsock,
    Senior Director Quality, Global Quality Systems, Eli Lilly and Company

    There are many opportunities for the microbiology laboratory to transform its often 20th century manual infrastructure by leveraging automation and digitization. The efficiencies and quality advantages of a 21st century laboratory are substantial, including better method reliability, preventing common manual errors, digital capture of data instead of transcription, more efficient batch release, and built-in data integrity security. The presenter will discuss the need to improve microbiology laboratory reliability to assure quality, CGMP compliance, and availability of safe and effective drugs for patients.

    07:15 | The Microbiology Lab of the 21st Century: Efficiency and Reliability through Automation and Digitization
    Robert Spignesi, MBA,
    CEO, Rapid Micro Biosystems

    07:40 | Q&A with Additional Panelist
    Kham Nguyen,
    Director of Validation, Rapid Micro Biosystems

    Breakfast 6: FDA’s Next Steps in Advancing Quality Metrics and Maturity
    Moderator: Denyse D. Baker, PE RAC, Senior Director of Global Regulatory Policy, AstraZeneca

    FDA has issued two important publications in 2022 in the area of quality maturity and metrics, 1) an update to the metrics program where FDA has suggested a menu of options for establishments to select, define, and report metrics; and 2) the Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals. Bring your questions to this breakfast session and hear from FDA leaders on the progress with both programs and what are the next steps toward implementation.

    07:15 | Advancing Regulatory Oversight: An Overview of Initiatives from the Office of Quality Surveillance
    Alex M. Viehmann,
    Division Director, OPQ, CDER, U.S. FDA

    07:40 | Q&A with Additional Panelists
    Jean Chung, Chemist, OPQ, CDER, U.S. FDA
    Jennifer A. Maguire, PhD, Director, Office of Quality Surveillance, OPQ, CDER, U.S. FDA

    Breakfast 7: Achieving Zero Defects
    Moderator: John D. Ayres, MD Risk Assessment Clinician, Pharma Safety Solutions, LLC

    The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. An important part of this effort is the control of particles that may emanate from the primary packaging materials. The scope of this PDA working group's activities will be discussed, including test and inspection methods, acceptance criterion considerations, and training opportunities.

    07:15 | PDA "Achieving Zero Defects for Visible Particles in Injectables" Working Group Update
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    07:40 | Q&A with Additional Panelist
    Ravi Patel,
    Director, Quality Engineering & Metrology, West Pharmaceutical Services, Inc.

    Breakfast 8: Water Systems
    Moderator: Mary Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc.

    Generating and delivering pharmaceutical grade water to our manufacturing processes remains a challenge despite decades of experience with this ubiquitous drug component. In this session, presenters will review case studies of how water system design, control, and maintenance can pose challenges to product quality and to compliance – and how improvements in our water system design, upkeep, and monitoring programs can help protect our products and patients.

    07:15 | Water System Design and Maintenance Case Study
    Cynthia L. Lake, Executive Director, Merck & Co., Inc.

    07:40 | Q&A with Additional Panelist
    Rebecca E. Dowd, MS,
    Supervisory Investigator, ORA, U.S. FDA

    08:30 – 10:00 | P5: Current GMP Compliance Trends and Topics
    Moderator: David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

    In this perennial “standing room only” session, presenters from CDER and CBER CGMP management will provide insights beyond the usual “Top 10” 483 observations. Attendees will learn about major CGMP issues and notable warning letters.

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

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

    09:20 | Q&A with Additional Panelists
    Lance M. De Souza, MBA, Director, Compliance Branch, OMPTO, ORA, U.S. FDA
    Marea K. Harmon, Consumer Safety Officer, CVM, U.S. FDA

    10:00 – 10:45 | Refreshment Break

    10:45 – 12:15 | Concurrent Sessions

    A5: Strong Investigations and CAPA
    Moderator: Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA

    Successful handling of manufacturing and quality problems requires a robust quality system that executes timely actions. Deviations, defects, complaints, and out of specification results are among the areas that require careful investigation to prevent marketed product recalls and supply shortfalls. Participants will learn about root cause analyses, deficiencies noted in audits, developing an effective Corrective and Preventive Actions (CAPA) plan, and how to properly evaluate such actions to incorporate adaptations that safeguard future batch production cycles of the product. This session will also discuss “What, Why, and How,” in order to scope out and close an investigation. Learn how to get all the information you need to correct a quality event and remain compliant.

    10:45 | Investigations Related to Media Fills and Sterility Testing
    Nicholas A. Violand,
    Investigator/Drug National Expert, ORA, U.S. FDA (INVITED)

    11:10 | A Case Study: Closed Loop Investigation System Ensures Identification and Remediation of True Root Cause
    Lori F. Hirsch, JD,
    Vice President, Regulatory Compliance and External Engagement, Bristol-Myers Squibb

    11:35 | Q&A with Additional Panelists
    Renée S. Blosser,
    Microbiologist, CVM, U.S. FDA (INVITED)
    Rebecca Parrilla, Consumer Safety Officer, OC, CDER, U.S. FDA

    B5: Understanding the Capability of Your Facility to Improve Quality Output
    Moderator: Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA

    Aging facilities and associated risks (“hazards”) therein have been a regulatory focus for many years. The potential impact of these risks on pharmaceutical operations and drug supply are just some of the many affecting consumer confidence and patient safety. Error prevention in equipment, facility, and process design is paramount to ensuring regulatory compliance and reliable supply, yet accurate determination of the root cause of errors can often present a challenge in aging facilities. Through case studies, the presenters will explore example ways to understand the capability of a facility, assess the risks within facilities, leverage existing technologies to modernize operations, and explore innovations that encourage flexibility, reliability, and sustainable compliance.

    10:45 | Leveraging Current Technology and Quality Signals to Unlock Bottlenecks in Production while Enhancing Quality Output
    Kurt E. Davies,
    Quality Site Lead, AstraZeneca

    11:10 | Proactive Assessment of Equipment Design to Enable Quality Improvements and Reliable Drug Supply
    Mark Wittrig,
    Director of Quality Operations, Pfizer (INVITED)

    11:35 | Q&A with Additional Panelist
    Carmelo Rosa, PsyD,
    Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

    C5: Lifecycle Management of Risks: From Original Application Approval to Post-Approval
    Moderator: Patricia F. Hughes, PhD, Senior Scientific Advisor, CDER, U.S. FDA

    This session will discuss the new FDA assessment tool, Knowledge-aided Assessment and Structured Application (KASA), which is intended to capture and manage knowledge during product lifecycle. KASA is a modernization tool to improve CMC structured data management and should allow for consistent product quality assessments, facilitate the use of new technological and manufacturing advances and improve product supplies during lifecycle. FDA will provide updates on KASA and related PQ/CMC initiatives and discuss progress made on CMC data structuring and use. Examples from industry on how to build CMC structured data for sharing, submission review, and post-approval management will be presented.

    10:45 | Role of KASA and Other Related Initiatives (PQ/CMC) to Manage Application Assessments and Post-Approval Lifecycle Management
    Lawrence Yu, PhD,
    Director, Office of New Drug Products, OPQ, CDER, U.S. FDA

    11:10 | Industry Perspective on CMC Data Structuring to Manage Knowledge During Product Lifecycle
    Michael J. Abernathy, MS, RAC,
    Executive Director, Regulatory Affairs, Amgen Inc.

    11:35 | Q&A

    12:30 – 1:30 | Lunch with the Regulators
    Moderators: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA and Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates 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.

    Brooke K. Higgins, MS,
    Senior Policy Advisor, CDER, U.S. FDA
    Laura S. Huffman, MS, Senior Policy Advisor, CVM, U.S. FDA
    Jeffrey D. Meng, MSE, Program Division Director, OPQO, ORA, U.S. FDA (INVITED)
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA
    Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA
    Wei Wang, PhD,
    Microbiologist, CBER, U.S. FDA

    13:45 – 14:45 | P6: Moving Forward
    Moderator: CAPT Tara Gooen Bizjak, MBS,
    Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    This thought-provoking closing session will discuss how collaboration, innovation, and applying lessons learned to advance industrial quality management are essential to our future success.

    13:45 | Moving Forward: The Good, the Bad, and the Ugly
    Martin G. VanTrieste,
    President Emeritus & Board Member, Civica Rx

    14:10 | The Halo Effect: A Discussion
    Shankar Vendantam, Podcast Host and Creator, The Hidden Brain

    14:35 | Q&A

    15:05 | Closing Remarks from Conference Co-Chairs

Highlighted Speakers

Juan Andres
Juan Andres
Moderna, Inc.
Donald D. Ashley
Donald D. Ashley
Jacqueline Corrigan-Curay
Jacqueline Corrigan-Curay
Alonza E. Cruse
Alonza E. Cruse
Susan Hynes
Susan Hynes
Peter W. Marks
Peter W. Marks
Judith McMeekin
Judith McMeekin
Martin G. VanTrieste
Martin G. VanTrieste
Civica Rx

Additional Information

  • Who Should Attend
    • 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
    • Pharmaceutical sciences
    • Regulatory science
    Global Regulatory Authorities

Got a Question? We have answers

Contact Us


Conference Elements In-Person Attendance Virtual 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 No
Interest Group Discussions with FDA Participation Yes No
Lunch with the Regulators 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


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 Hotel

999 9th Street, NW
Washington, DC
Phone: +1 (202) 898-9000

Make a Reservation
Renaissance Washington, DC Downtown Hotel
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $322 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, 15 August 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Renaissance at +1 (202) 898-9000. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. Set in the heart of the city, our upscale hotel is steps from Capital One Arena, Penn Quarter and the Walter E. Washington Convention Center. From museums to entertainment, this is the perfect base for exploring downtown D.C.

    At days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 5 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27.8 miles away, and Baltimore-Washington International Airport (BWI), 34 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

The Renaissance Washington, DC Downtown Hotel is located at 999 9th Street NW, Washington, DC. Parking is available onsite at the following rates: Daily Self Parking - $35; Daily Valet Parking - $60.18

Other Options

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 USD one way to Ronald Reagan Washington National Airport (DCA). Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit


Registration Fees

Regular Price
Registration Type In-Person Attendance Virtual Attendance
Not all sessions will be livestreamed
Member $2,795 $2,295
Non-Member $3,095 $2,595
Govt./Health Authority/Academic (Member/Non-Member*) $700 $700
Student (Member/Non-Member*) $350 $350
Early Career Professional (Member Only) $1,395 $1,395

* For this member type or discount, online registration is not available, please contact [email protected].

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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Program Inquiries
  • Molly E. O’Neill, CMP
    Vice President
    Tel: +1 (301) 656-5900 ext. 132
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[email protected]

Tel: +49 (0) 30 43 655 08-10
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