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2020 PDA/FDA Joint Regulatory Conference

The Future is Now: Effective Quality Management and Robust Manufacturing

Sep 14 - Sep 16, 2020
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online
Program Highlights
New this year, the 2020 PDA/FDA Joint Regulatory Conference will be totally virtual! Attend the conference from anywhere in the world from the comfort of your computer. Sessions  will be recorded and available on-demand for 30 days post-conference for paid registrants!


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 29th year. This flagship conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and related compliance issues in an ever-evolving landscape. This year’s theme is “The Future Is Now: Effective Quality Management and Robust Manufacturing,” and will explore the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. The conference proceedings will delve into the details through the discussion of latest innovative technologies, case studies, regulatory expectations, and forward-looking perspectives in sessions, such as:

  • Commercialization challenges in cell and gene therapy
  • Data analytics in manufacturing
  • De-risking your Supply Chain
  • The Quality Assurance role in 2020 and beyond
  • ICH quality initiatives
  • OOS investigations
  • Process validation lifecycle
  • Combination products, diagnostics, and software as a medical device
  • U.S. FDA Emerging Technology Program
  • Using risk management to reduce the risk of drug shortage
  • Utilizing modeling in manufacturing

This year’s conference focuses on advancing quality management and the robust manufacturing of innovative drugs, biologics, and combination products. Combined efforts of industry and regulators are necessary to assure uninterrupted supplies of safe and high-quality products while advancing the use of new capabilities.

In addition to the above topics, attendees will also learn about hot topics such as supplier quality control, new large volume parenteral technical approaches, joint inspection program for sterile drugs, human performance tools to help strengthen deviation management, preventing nitrosamine impurities, and how regulators assess firms in times of crises. FDA senior officials will discuss Center-specific initiatives as well as provide compliance updates.


  • Day 1
  • Day 2
  • Day 3
  • Monday, September 14

    10:00 a.m. – 11:45 a.m. | P1: Pharmaceutical Quality Management: What Are We Learning from Current Challenges
    Moderator: John D. Ayres, MD,
    Risk Assessment Clinican, Pharma Safety Solutions, LLC

    This year's conference theme "The Future Is Now: Effective Quality Management and Robust Manufacturing" could not have been more foretelling of current pandemic-related events unfolding before us. The evolving pandemic has exposed meaningful vulnerabilities in the infrastructure and capabilities of governmental public health partnerships, healthcare systems, and the pharmaceutical industry. These limitations played a significant role in necessitating a stringent self-isolation quarantine to reduce morbidity and mortality and to mitigate the impact to hospitals, drug shortages, and global market instability. For the pharmaceutical industry, now more than ever, effective quality management systems, oversight, robust manufacturing processes, and quality culture are critical to rise to the current public health challenges.

    This session will explore some of these weaker elements exposed by the current events. Importantly, what aspects of partnerships, systems, and enterprises have been 'stress-tested' by pandemics, natural disasters, material shortages, and other supply chain challenges. A critical assessment of these elements serves as the necessary first step in developing tangible and thoughtful approaches to managing these issues.

    10:00 a.m. | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
    Richard M. Johnson, MSc, President and CEO, PDA
    Jette Christensen, Chair, PDA Board of Directors
    CDR Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA
    John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    10:15 a.m. | The Pharmaceutical Supply Chain: Current Challenges and Future Vision
    Douglas  R. Throckmorton, MD, Deputy Director of Regulatory Programs, CDER, U.S. FDA

    10:45 a.m. | Niya D. Bowers, PhD, Senior Program Officer, Bill & Melinda Gates Foundation

    11:15 a.m. | Q&A

    11:45 a.m. – 12:00 p.m. | Break

    12:00 p.m. – 1:30 p.m. | P2: Quality Assurance in 2020 Means Managing Risks Beyond Your Own Facilities
    Moderator: Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA

    In the year 2020, the supply chain has never been more intricate. Strong quality systems must oversee the ongoing dynamics during the commercial lifecycle, including maintaining current knowledge of identity and capability of all parties in the supply chain. Two top quality assurance executives will provide insights into lifecycle management of suppliers, as well as new risk management strategies involved with integrating use of modern products and new technologies. An industry CEO will discuss how a strong quality management system (QMS), and candid customer relationships, assures that issues are identified and effectively resolved to prevent quality and safety consequences.

    12:00 p.m. | Managing Your Supply Chain: Handling Expected and Unexpected Challenges
    Guy Villax, CEO, Hovione

    12:25 p.m. | De-Risking Your Supply Chain: Critical Quality Assurance (QA) Role
    Andrea J. Goddard, Senior Vice President and Head of Quality and Compliance, Roche Pharma Technical Operations  

    12:50 p.m. | Supply Risk Management for New Product Introductions and Modern Technology
    Sean McEwen, MA, Vice President Quality Assurance, AbbVie Inc.  

    1:15 p.m. | Q&A

    1:30 p.m. – 2:15 p.m. | Virtual Exhibit Hall Open

    2:15 p.m. – 3:45 p.m. | Concurrent Sessions

    A1: Quality Risk Management
    Moderator: Rebecca E. Dombrowski, MS, Supervisory Investigator, ORA, U.S. FDA

    As detailed in ICH Q9, “quality risk management (QRM) is a systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle.” In light of current events, the need for a robust and adaptive QRM system is underscored. 

    This session will provide insight from industry and key FDA officials regarding the expectations for QRM as the core of a mature quality culture. Discussions will focus on the key role of QRM in reaching an effective and sustainable quality maturity level, as well as the translation of a maturity model to implementation of quality on the “shop floor.”

    2:15 p.m. | Risk Management Approaches for Pharmaceutical Manufacturing Systems
    Richard Derek Glover, Head of Global Quality, Mylan N.V.

    2:35 p.m. | Measuring Up and Across – Risk Registers and Communication
    Jason M. Urban, PhD,
    Senior Director, Quality Risk Management, Alexion Pharmaceuticals

    2:55 p.m. | CDR John W. Diehl, MS, Director, Compliance Branch, ORA, U.S. FDA

    3:15 p.m. | Q&A

    B1: Covid-19 Vaccine Development
    Moderator: Douglas A. Campbell, Senior Consultant, InterPro QRA

    Since the beginning of 2020, the effects of the COVID-19 pandemic have been evident in our personal and professional lives, and most agree that an effective vaccine is the key to a return to life and work as we knew it. The call-to-action generated an unprecedented collaboration, between researchers in different countries and in different pharmaceutical companies, to develop a vaccine. While there may be an understanding of the similarities between SARS-CoV (Severe Acute Respiratory Syndrome; outbreak in 2003) and SARS-CoV-2 (which belongs to the same Betacoronavirus genus), this session will include information relating to the challenges of developing a vaccine for a “novel” virus. At the same time, appropriate flexibility by the U.S. FDA and other regulatory agencies is important to serve the public health mission and the desire to accelerate the stages to enable distribution of a vaccine as soon as possible. The presentations in this session will provide context for what has been accomplished. There will also be updates on the progress of the development, manufacturing, and distribution timelines.

    2:15 p.m. | COVID, BARDA, and Operation Warp Speed (OWS)
    Clement Lewin, MBA, PhD,
    AVP Head BARDA Office and NV Stakeholder Engagement, Sanofi

    2:45 p.m. | Regulator Invited

    3:15 p.m. | Q&A

    C1: What’s Happening with ICH Quality Initiatives?
    Moderator: Clarice H. Hutchens, PhD, MA, DM, Senior Director, Pfizer

    Industry will present ICH Quality Discussion Group (QDG) initiatives regarding ICH quality (Q) and relevant multidisciplinary (M) guidelines with an emphasis on the challenges associated with contemporizing many of these for the future. ICH has dramatically improved global harmonization of regulatory expectations. ICH Q guidelines have provided direction for global regulatory convergence based on science and risk-based approaches. However, interpretation and implementation have been inconsistent, especially for ICH Q – 8, 9, 10, and 11. While global regulatory harmonization through a product’s lifecycle is a significant challenge, ICH has established a reasonably effective paradigm for improving convergence of regulatory expectations and alignment of innovative approaches to pharmaceutical commercialization. FDA will share their experiences on implementation of ICH Q12 as a primary example of opportunities and challenges for regulatory harmonization.

    2:15 p.m. | The Future of ICH Quality Guidance
    Roger Nosal, MA, Vice President, GCMC, Pfizer

    2:45 p.m. | Regulator Invited

    3:15 p.m. | Q&A

    3:45 p.m. – 4:00 p.m. | Break

    4:00 p.m. – 5:00 p.m. | Special Topic Sessions

    Special Topic 1: Mission Impossible? Data Integrity and Manufacturing Processes
    Moderator: Valerie Whelan, Vice President, Head of R&D Quality and Compliance, Amgen Inc.

    Expectations around data integrity are not something new to our industry. The FDA issued 21 CFR Part 11 in 1997 to establish the criteria for the use of electronic records and electronic signatures in complying with predicate rules. As early as 2000, a warning letter was issued citing lack of control over computerized laboratory systems. While progress has certainly been made in the intervening 20+ years particularly in QC Laboratories, the basic expectations are still often found to be deficient within the manufacturing space and the need to evaluate the risks in the research and development space appears to have been overlooked by many. Leveraging the new PDA TR, this session will revisit the expectations and particularly the opportunities to ‘build in’ data integrity elements in manufacturing to succeed in this mission.   

    4:00 p.m. | TR84: Integrating Data Integrity Requirements into Manufacturing and Packaging Operations
    Anne M. Pericone, MBA,
    Director, Quality Systems Integration, Johnson & Johnson

    4:30 p.m. | Q&A with Additional Panelist
    Els Poff, Executive Director, Data Integrity Center of Excellence, Merck & Co., Inc. (INVITED)

    Special Topic 2: Supplier Quality Control
    Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    PDA is an ANSI recognized standard development organization. The first standard developed by PDA and endorsed by ANSI is BSR/PDA Standard 01-201x, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices, and Combination Products Industries.

    This session will briefly discuss the ANSI standard setting process that PDA must adhere as required by ANSI. The majority of this session will focus on the recommendations contained in the standard that can help companies secure their supply chains and their ability to develop and manufacture high quality medicines without interruption to patient.

    4:00 p.m. | ANSI/PDA Standard 001-2020: Enhanced Purchasing Controls to Support the Biopharmaceutical Industry
    Martin G. VanTrieste,
    President and CEO, Civica Inc

    4:30 p.m. | Q&A

    Special Topic 3: LVP New Technical Approaches
    Moderator: Bing Cai, PhD, Division Director, CDER, U.S. FDA

    This session will focus on the large volume parenteral (LVP) new technical approaches and related issues in manufacturing process quality control and review assessment.

    4:00 p.m. | Effective Quality Management and Robust Manufacturing
    Neal A. Zupec, Senior Research Scientist/GST/CoE, Baxter Healthcare

    4:20 p.m. | Q&A with Additional Panelist
    Kristina M. Adams, PhD, Chemist, CDER, U.S. FDA

    Special Topic 4: Joint Inspection Program for Sterile Drugs
    Moderator: David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

    Major regulatory health authorities, including FDA, EMA, TGA, PMDA, and WHO have established a pilot program to share information on sterile inspections and to plan for join inspections for manufacturing facilities of common interest. This program was recently announced and will last for a period of two years. This session will feature a representative who is involved in this pilot program and can explain some of the operational details of the program.

    4:00 p.m. | International Sterile Finished Dosage Product Pilot
    Fernando J. Gonzalez,
    Operations Research Analyst, CDER, U.S. FDA

    4:30 p.m. | Q&A
  • Tuesday, September 15

    8:45 a.m. – 9:45 a.m. | Concurrent Special Topic Sessions

    Special Topic 5: Things Go Wrong Because They Usually Go Right: Human Performance Tools Help Strengthen Deviation Management
    Moderator: Mike G. Labruto, MS, Executive Director, GlaxoSmithKline

    Learning and listening to signals from our systems (organization/job design/individuals) is critical to advancing a robust investigation management program. Use of various tools, such as the human reliability tool, helps ensure learnings are applied to support organizational resilience.

    Introducing proactive approaches in addition to the corrective and preventive actions traditionally adopted, will aid in the understanding of why issues happen and help reduce occurrence of similar/repeat events.

    8:45 a.m. | Pioneering Human Factor Analysis
    Joseph M. Polizzotto, Operational Quality Manager, GlaxoSmithKline

    9:15 a.m. | Q&A

    Special Topic 6:  Standards Update
    Moderator: Carol L. Rehkopf, MS, Deputy Associate Director, CBER IOD Review Management, CBER, U.S. FDA

    This session will provide current information about FDA’s view on the use of standards with pharmaceutical products, including how standards are developed and how they can be used in a regulatory application.

    8:45 a.m. | Standards Development and Use in the FDA Center for Biologics Evaluation and Research (CBER)
    Judith A. Arcidiacono, MS,
    Regulatory Expert, CBER, U.S. FDA

    9:15 a.m. | Q&A

    Special Topic 7: Mergers and Acquisitions Landscape: Combining Quality Systems and Realizing What You Have Inherited
    Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    In today’s environment there are an increased number of mergers and acquisitions as well as contract manufacturing agreements that require companies to combine, adapt or modify quality systems to satisfy the business needs. This activity can be challenging to the organizations involved in the merging of their businesses.

    This session will offer participants practical solutions and ideas to blend quality systems by taking advantage of the knowledge and expertise of industry leaders who have helped companies establish and maintain a robust quality system while they integrate the various process and procedures from the merging partners.

    8:45 a.m. | Panel Discussion
    Douglas A. Campbell, Senior Consultant, InterPro QRA
    David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC
    Rebecca A. Devine, PhD, Biopharmaceutical Consultant
    Rebecca E. Dombrowski, MS, Supervisory Investigator, ORA, U.S. FDA
    Valerie Whelan, BSc, Vice President, Head of R&D Quality and Compliance, Amgen Inc.

    9:45 a.m. – 10:00 a.m. | Break

    10:00 a.m. – 11:30 a.m. | P3: Compliance Updates
    Moderator: David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

    Featuring Compliance Directors from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. It will focus on challenges and deficiencies that U.S. FDA has found during inspections, significant regulatory actions initiated, and U.S. FDA’s current enforcement strategy for a wide array of regulated products. In a Roundtable format, U.S. FDA’s top leaders in Compliance and Enforcement will describe their programs and initiatives related to inspection and compliance activities. This is the best possible opportunity for you to understand U.S. FDA’s thinking and expectations for Good X Practice (GXP) compliance of the industry. Most importantly, there will be ample time for the audience to ask probing questions of U.S. FDA’s top leadership.

    10:00 a.m. | CDER Compliance Updates 
    Donald D. Ashley, JD, Director, Office of Compliance, CDER, U.S. FDA

    10:15 a.m. | ORA Compliance Updates
    Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA

    10:30 a.m. | CBER Compliance Updates
    Melissa J. Mendoza, JD, Deputy Director, Office of Compliance and Biologics Quality, CBER, U.S. FDA

    10:45 a.m. | CVM Compliance Updates
    Timothy C. Schell, PhD, Director, Office of Surveillance and Compliance, CVM, U.S., FDA

    11:00 a.m. | Roundtable Discussion

    11:30 a.m. – 11:45 a.m. | Break

    11:45 a.m. – 1:15 p.m. | Concurrent Sessions

    A2: Compliance/GMP Updates
    Moderator: David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

    It’s back by popular demand! This session will include presentations from CDER and CBER compliance managers that are designed to provide more than just the usual “Top 10” 483 observations and a summary of the latest warning letters. These presentations will be followed by a panel discussion with panelists from each of the Agency’s Centers and will be an opportunity for participants to gather specific insight.

    11:45 a.m. | Francis RW Godwin, MBA, Office Director, CDER, U.S. FDA

    12:15 p.m. | Maria C. H. Anderson, MS, Branch Chief, Biological Drug and Device Compliance Branch, CBER, U.S. FDA

    12:45 p.m. | Q&A with Additional Panelists
    Stephanie Durso, CPH, Director - Compliance Branch, ORA, U.S. FDA
    Marea K. Harmon, Consumer Safety Officer, CVM, U.S. FDA

    B2: Cell and Gene Therapy: The Challenges of Commercialization
    Moderator: Anthony F. Lorenzo, Team Lead, CBER, U.S. FDA

    One of the most innovative and revolutionary advancement in the treatment and control of diseases in this era is cell and gene therapy. As of January 2020, the FDA has approved four gene therapy products and over 900 investigational new drug (IND) applications in this area are in clinical studies.

    These new therapies rapidly move from clinical trials into commercial manufacturing with little time available to mature the manufacturing process. What are the challenges to the innovators of this new therapy when licensed and approved? Speaking on this subject will be a representative from industry.

    The rapid development and unique manufacturing strategy challenged the regulators paradigm. How did the FDA approach the unique aspects of the manufacturing process and the risks associated with the personalized approach of this treatment? Speaking on this subject will be a representative from the FDA.

    11:45 a.m. | Quality and Regulatory Issues Towards Commercialization of Cell and Gene Therapy Products
    W. Bryan Silvey, Senior Director, Head - Global Quality Compliance, Kite, a Gilead Company

    12:15 p.m. | FDA Perspective on Commercial Facility Designs for Cell and Gene Therapy Products
    Lily Y. Koo, PhD, Consumer Safety Officer CBER, U.S. FDA

    12:45 p.m. | Q&A with Additional Panelists
    Regulators Invited

    C2: Utilizing Modeling in Manufacturing
    Moderator: Ellen A. Huang, Senior Advisor, ORA, U.S. FDA

    Significant advancements have been made in manufacturing technology and scientific innovation in the past several years, in part due to modeling. Modeling is a powerful tool that has helped accelerate drug development and optimized manufacturing and facility design. Modeling has also been used to resolve some of the most challenging issues in manufacturing robustness and control. Statistical modeling can provide a common language and neutral ground for bridging problem-solving efforts across disciplines and backgrounds. This session will explore the use of modeling for improving various aspects of manufacturing, from determining equipment limitations to defining design space to linking scientific practice to GMP. Use cases for physics-based simulations in process development, validation, monitoring and process deviation analysis will be discussed.  Introduction of data-based strategies early in development through commercialization sets the foundation for a more robust control strategy and can preempt the need for investigations later.

    11:45 a.m. | Modeling Lyophilization
    Alina A. Alexeenko, PhD, Professor of Aero & Aeronautics and Prof. of Chemical Engineering; Co-Director, Advanced Lyophilization Technology Hub, Purdue University

    12:15 p.m. | Control Strategy Grounded in Process Modeling
    Julia C. O’Neill, MS, Principal Consultant, Direxa Consulting

    12:45 p.m. | Q&A with Additional Panelists
    Francisco Vicenty, Consumer Safety Officer, CDRH, U.S. FDA

    1:15 p.m. – 2:00 p.m. | Virtual Exhibit Hall Open

    2:00 p.m. – 3:30 p.m. | Concurrent Sessions

    A3: Risk Management Planning to Reduce Drug Shortage Risk
    Moderator: Neil A. Stiber, PhD, Associate Director for Science and Communication, Office of Surveillance, CDER, U.S. FDA

    How does risk management planning help maintain robust supply chains and prevent drug shortages?  Drug shortages, whether in normal times, or as the result of emergencies, pose significant threats to patient outcomes.  Multiple difficult-to-predict factors influence drug shortages including raw material availability and price, global vulnerabilities, demand fluctuations, and quality control.  How can these factors, and others, be incorporated into a pharmaceutical company’s risk management plan?  What firms have shown success mitigating, managing, and preventing shortages and how did a risk management plan provide them with useful data and perspectives?  How does considering the element of “surprise” add value and resilience to risk management?

    2:00 p.m. | Risk Management Plans to Mitigate the Potential for Drug Shortages
    Grace E. McNally,
    Director, Division of Regulations and Guidance, Office of Policy for Pharmaceutical Quality, CDER, U.S. FDA

    2:30 p.m. | Diane L. Hustead, MS, Director, Regulatory Affairs, Merck

    3:00 p.m. | Q&A with Additional Panelists
    Melanie L. Power-Burns,
    Senior Vice President, Quality, North America, Fresenius Kabi USA, LLC
    CDR Emily T. Thakur, RPh, Team Leader, CDER, U.S. FDA

    B3: Seizing the Product Surveillance Opportunity
    Moderator: Valerie Whelan,
    Vice President, Head of R&D Quality and Compliance, Amgen Inc.

    When you hear the words 'Product Complaint' or 'Adverse Event' are you typically filled with dread, does your Quality System provide easy access to data to help understand root causes and trend consolidated data across all aspects of product surveillance, do you see these activities as necessary evils of our industry or real opportunities for process improvement, waste minimization and most importantly avenues to help protect patients and improve their product experience?

    In this session we will explore how industry and the regulators are reimagining this space to drive improved understanding and more effective CAPAs; tackle the question of who owns this part of the QMS and we will hear what the learnings have been so far, good and bad, with leveraging data analytics in this space.

    2:00 p.m. | Future State of Adverse Event/Product Complaint Surveillance
    Doug A. Roepke, MD,
    Medical Fellow, Lilly Global Patient Safety Medical - Product Safety Assessments, Eli Lilly and Company

    2:30 p.m. | Regulator Invited

    3:00 p.m. | Q&A with Additional Panelists
    David J. Jaworski, MBA,
    Senior Policy Advisor, CDER, U.S. FDA
    Elise A. Murphy, Supervisory, Consumer Safety Officer, CDER, U.S. FDA

    C3: Data Analytics in Pharmaceutical Manufacturing
    Moderator: Sharyl D. Hartsock,
    Senior Director Quality, Global Quality Systems, Eli Lilly and Company

    We have all heard the adage, "with knowledge comes power." This is especially true in the pharmaceutical industry where robust data enable confident decision making and drive operational efficiency. Digital maturity and data integrity by design have become key elements of the digitalized operations model of a pharmaceutical organization. As such, the role of data analytics in manufacturing has increased in importance. In this session, the FDA will highlight the value of trending data to drive quality improvements. In addition, a representative from industry will demonstrate how visualization and analysis of manufacturing data can result in the answers you need to transform operations in a Pharma 4.0TM context.

    2:00 p.m. | Trending Data to Drive Quality Improvements
    CDR Tara Gooen Bizjak, MBS,
    Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    2:30 p.m. | Data Analytics: Holistic Approach to Implement the Digital Plant
    Wilfred J. Mascarenas, MS ME, MS CS,
    Advisor - Data and Analytics, Eli Lilly and Company

    3:00 p.m. | Q&A

    3:30 p.m. – 3:45 p.m. | Break

    3:45 p.m. – 5:15 p.m. |Ask the Regulators
    U.S. FDA investigators, reviewers, and compliance officers will answer your questions in this Q&A session that will allow for direct input and will provide you with insights regarding inspection trends and center initiatives.

    Review-Based Panel Discussion
    Rebecca A. Devine, PhD, Biopharmaceutical Consultant
    Thuy T. Nguyen, DHSc, Acting Branch Chief, CDER, U.S. FDA

    3:45 p.m. | Q&A Panel

    • Renée S. Blosser, MS, Microbiologist, CVM, U.S. FDA
    • Bing Cai, PhD, Division Director, CDER, U.S. FDA
    • William Hallett, Supervisory Chemist, CDER, U.S. FDA
    • Zhihao Peter Qiu, PhD, Acting Director, Division of Microbiology Assessment, Office of Pharmaceutical Manufacturing Assessment, CDER, U.S. FDA
    • Additional Regulators Invited

    Inspection-Based Panel Discussion
    Mai X. Huynh, MS,
    Supervisory Chemist, CVM, U.S. FDA
    Ellen A. Huang, Senior Advisor, ORA, U.S. FDA

    3:45 p.m. | Q&A Panel

    • Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA
    • Laura S. Huffman, MS, Microbiologist, CVM, U.S. FDA
    • Quallyna N. Porte, MBA, Branch Chief (Acting), CDER, U.S. FDA
    • Additional Regulators Invited
  • Wednesday, September 16

    8:45 a.m. – 9:45 a.m. | Concurrent Special Topic Sessions

    Special Topic 8:  The Case for Quality
    Moderator: LCDR Timothy M. Martin, PhD, EIT, Regulatory Officer, CBER, US. FDA

    Focusing on the quality of medical devices is in everyone's best interest. There are widespread or common manufacturing risks that impact product quality. Manufacturers that focus on and manage those risks often become more productive, receive fewer complaints, require fewer Corrective and Preventive Actions and investigations, and have lower quality-related product costs.

    This session will discuss how to improve medical device quality, safety, and patient outcomes by building trust, collaboration, and moving beyond compliance.

    8:45 a.m. | Francisco Vicenty, Consumer Safety Officer, CDRH, U.S. FDA

    9:15 a.m. | Q&A Panel with Additional Panelist
    Sara A. Sulfridge, Senior Director Quality Strategy, Baxter Healthcare

    Special Topic 9:  Nitrosamines
    Moderator: Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc.

    Nitrosamines are ubiquitous within the environment and food supply, and their formation has been well-documented and well-studied for years – but nitrosamine formation within the pharmaceutical industry has been a very recent challenge. This session will explore some of the ways the industry is meeting the challenges these molecules pose. Various sources of nitrosamines as well as some of the limitations of the analytical methods currently used to detect them will be discussed as well as how to determine appropriate safety levels for this class of molecules and the applicability of ICH M7’s safety principles in corresponding risk analyses.

    8:45 a.m. | Ganapathy Mohan, PhD, Executive Director, Merck & Co., Inc.

    9:15 a.m. | Q&A with Additional Panelist
    Oliver R. Thiel, PhD, Executive Director, Amgen Inc.

    Special Topic 10: Conducting and Managing Remote Assessments
    Moderator: Jacqueline A. Kunzler, PhD, MBA, Senior Vice President, Chief Quality Officer, Baxter Healthcare Corporation

    What are the challenges and best practices for both conducting and managing through desktop (remote) audits? From technology to attendees to sharing of information, there is a lot to think about to enable a streamlined remote audit.

    8:45 a.m. | Monica Markovski Commerford, PhD, Manager, Regulatory Affairs, Thermo Fisher Scientific

    9:05 a.m. | Susanna Kerschl, PhD, TUV Lead Auditor and Account Manager, TÜV SÜD Product Service GmbH (INVITED)

    9:25 a.m. | Q&A Panel

    10:00 a.m. – 11:30 a.m. | P4: Center Updates
    Moderator: Valerie Whelan, Vice President, Head of R&D Quality and Compliance, Amgen 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 can U.S. FDA continue to lead and fulfill the promises of recent advancements to product quality while assuring the availability of high-quality medicines every day? Discuss these issues with U.S. FDA senior management officials from various U.S. FDA Centers in this highly interactive session! In a round table format, the conversation will focus on key issues that are cross-cutting to the different centers and relevant to the entire pharmaceutical space. The session organizers are looking for your questions and input, so come prepared to raise questions and discuss with these senior leaders.

    10:00 a.m. | CBER Updates
    Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA

    10:17 a.m. | CDER Updates
    Douglas  R. Throckmorton, MD, Deputy Director of Regulatory Programs, CDER, U.S. FDA

    10:32 a.m. | CVM Updates
    Steven M. Solomon, DVM, MPH, Director, CVM, U.S. FDA

    10:47 a.m. | ORA Updates
    Elizabeth P. Miller, PharmD, Assistant Commissioner, Medical Products and Tobacco Operations, ORA, U.S. FDA

    11:02 a.m. | Roundtable Discussion

    11:30 a.m. – 11:45 a.m. | Break

    11:45 a.m. – 1:15 p.m. | Concurrent Sessions

    A4: OOS Investigations: Dynamic and Strategic
    Moderator: Lynnsey A. Renn, PhD, Public Health Analyst, Office of Manufacturing Quality, CDER, U.S. FDA

    Although regulatory guidance exists for out-of-specification (OOS) test result investigations, inadequate OOS investigations are still commonly cited during inspections and on FDA Warning Letters. Adequate documentation, unbiased root cause analysis, and sound scientific evidence to support conclusions are critical to OOS investigations. Determining the root cause of OOS results, including, where necessary, expanding investigations to address potential manufacturing causes, is key to implementing effective corrective actions and preventive actions (CAPA). This session aims to discuss the regulators current thinking on OOS test result investigations and to provide case studies of OOS test result investigations.

    11:45 a.m. | Christine E. Gray, Lead Senior Inspector, UK MHRA

    12:17 p.m. | OOS Investigation Techniques and Preventative Measures
    Mark W. Roy, Director of Quality Control Business Strategy, Quality Control, Sanofi

    12:47 p.m. | Q&A with Additional Panelist
    Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA

    B4: Quality Role in Design of Facilities and Maintenance Operations
    Moderator: David J. Jaworski, MBA, Senior Policy Advisor, CDER, U.S. FDA

    A quality system can provide the necessary framework for implementing quality by design (building in quality using a strong process development program), a vigilant monitoring program, continual improvement, and risk management in the drug manufacturing process.

    Quality managers set implementation priorities and develop action plans. All levels of management can provide support of the quality system by:
    • Actively participating in system design, implementation, and monitoring, including system review
    • Advocating continual improvement of operations of the quality system
    • Committing necessary resources to supply and maintain facilities with the appropriate equipment to consistently manufacture a quality product. This includes periodic evaluation of equipment as technology changes and customer needs change, as well as proactive and preventive maintenance of facilities as they age and production increases
    • Review maintenance and engineering practices
    • Develop facility and maintenance knowledge management databases.

    11:45 a.m. | Glenn E. Wright, MS, Vice President, Science and Regulatory Affairs, PDA

    12:17 p.m. | FDA Perspective on Design on Facilities and Maintenance Operations
    Quallyna N. Porte, MBA, Branch Chief (Acting), CDER, U.S. FDA

    12:47 p.m. | Q&A

    C4: FDA Emerging Technology Program
    Moderators: Thuy T. Nguyen, DHSc, Acting Branch Chief, CDER, U.S. FDA

    The FDA established an Emerging Technologies Team (ETT) in 2014 to facilitate and promote the use of technologies that have not been widely used in the industry. The Emerging Technology Program requires collaboration between the FDA and the pharmaceutical industry. This session will provide an overview of the current status of the FDA’s Emerging Technology program, as well as challenges and opportunities from an industry perspective.

    11:45 a.m. | Overview of the FDA Emerging Technology Program
    Sau (Larry) Lee, PhD, Director, CDER, U.S. FDA

    12:17 p.m. | Pharmaceutical Innovation: Challenges and Opportunities from an Industry Perspective
    Socrates Kyritsis, MSE, Area Head, Regulatory Affairs CMC, Global Drug Development, Novartis Pharma AG

    12:47 p.m. | Q&A

    1:15 p.m. – 2:00 p.m. | Virtual Exhibit Hall Open

    2:00 p.m. – 3:30 p.m. | Concurrent Sessions

    A5: Combination Products, Diagnostics, and Software as a Medical Device
    Moderator: Denise M. DiGiulio, Senior Director, Johnson & Johnson

    This session will provide an update of FDA drug/device combination product regulations and initiatives focusing on how the Intercenter consult request (ICCR) process works for a CDER-led Drug-Device novel Combination Product. Additionally, case studies from FDA and industry perspectives highlighting how the complex product quality CMC-related review and inspection challenges are successfully addressed and managed will be presented.

    2:00 p.m. | Steve B. Hertz, MS, MBA, PE, Consumer Safety Officer, CDER, U.S. FDA

    2:32 p.m. | Combination Products: An Industry Perspective
    Karyn M. Campbell,
    Senior Director, QA Audit and Compliance, AbbVie Inc.

    3:02 p.m. | Q&A with Additional Panelists
    Susan W. Neadle, MS, FAAO, DEx BB, PE BB, Senior Director, Johnson & Johnson
    John (Barr) Weiner, Associate Director for Policy, Office of Combination Products, OC, U.S. FDA 

    B5: Process Validation (PV): You Are Always Validating Your Process – What Does PV Mean to You?
    Moderator: Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA

    We are counting down to the 10th anniversary of the U.S. FDA publishing the “Guidance for Industry: Process Validation: General Principles and Practices.” This session will provide conference attendees an opportunity to refresh their knowledge on various activities associated with process validation, including discussion of knowledge and data from development lots and commercial scale studies, along with continued process verification (CPV). The expectation for effective CPV was established in 2011 and has been evolving, along with specific challenges ranging from globalization to the commercial manufacturing frontiers of cell and gene therapy products. Insights related to the current industry standard for developing a plan for CPV and how data analysis and procedures to monitor out-of-trend (OOT) results are examples of important components for your product evaluations.

    Representatives from FDA and regulated industry will present case studies for the collection and evaluation of such data typical of each stage of the process validation to illustrate how manufacturers can ensure that the process can consistently produce quality product under commercial manufacturing conditions. Product lifecycle management is critical to understanding and maintaining the quality of the product.

    2:00 p.m. | New PDA Technical Report: Strategies for Vaccines Development and Lifecycle Management
    Cristiana Campa, PhD, Technical R&D Advisor, GSK Vaccines

    2:22 p.m. | Embedding the Validation Lifecycle Approach as an Enabler for Product Robustness
    Mark D. O'Connor, Technical Manager - Validation Sciences, AstraZeneca

    2:42 p.m. | An Investigator’s Approach to Process Validation
    LCDR Jeffrey D. Meng, Director, Investigations Branch, ORA, U.S. FDA

    3:02 p.m. | Q&A with Additional Panelist
    Laura S. Huffman, MS, Microbiologist, CVM, U.S. FDA

    C5: Quality Organization for the Future
    Moderators: Jacqueline A. Kunzler, PhD, MBA, Senior Vice President, Chief Quality Officer, Baxter Healthcare Corporation

    Our industry has matured over the last 20 years to understand that the role of the quality organization is far more than quality control and/or compliance. In fact, the realization that a finished product is impacted by so many variables within the end to end supply chain has resulted in, rightfully, an expansion of the breadth of the quality function responsibility. In this session, we will review and contemplate the role for the quality organization of the future including specific skill sets that are needed and which, we need to cultivate. Additionally, we will utilize real-world examples to demonstrate what happens when quality oversight is lacking.

    2:00 p.m. | Lorianne Richter, Director, Risk Management, Ultragenyx

    2:32 p.m. | Quality Organization of the Future
    Donna Gulbinski,
    Chief Quality Officer, Civica Inc

    3:02 p.m. | Q&A with Additional Panelist
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA

    3:45 p.m. – 5:30 p.m. | P5: Pharmaceutical Quality Management: Applying Learnings from the Past to Transform the Future
    Moderator: CDR Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    “Do not pretend that things will change if we always do the same. The crisis is the best blessing that can happen to people and countries, because the crisis brings progress.”  - Albert Einstein

    Over ten years ago, Q10 Pharmaceutical Quality Systems described quality system elements and management responsibilities which are intended to encourage the use of science- and risk-based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle.  In our current environment, we are confronted with many opportunities to continually improve and adapt to changes in the world and public health.  The topics covered in this conference relating to pharmaceutical manufacturing, such as effective quality management systems, supply chains, modern CAPA, robust data analysis, and quality risk management and risk management plans, encourage us to continually refocus our thinking on what can be further enhanced, upgraded, and improved in pharma manufacturing. In this session, industry representatives will integrate topics from many of the conference’s discussions regarding current initiatives and share forward-looking vision and new strategies for product lifecycle management and continual improvement, such as:

    • Development and manufacturing innovations to improve process capabilities and drug quality;
    • Maximizing human potential and robust product quality through knowledge management; and
    • Modernizing regulatory approaches to promote agile and efficient manufacturing improvements that assure consistent, quality product and support exceptional patient outcomes.

    3:45 p.m. | Tia L. Bush, Senior Vice President, Quality, Amgen Inc.

    4:17 p.m. | David K. Elder, Executive Vice President, Greenleaf Health

    4:47 p.m. | Q&A

    5:17 p.m. | Closing Remarks from Conference Co-Chairs

Highlighted Speakers

Niya D. Bowers
Niya D. Bowers
Bill & Melinda Gates Foundation
Tia L. Bush
Tia L. Bush
Amgen Inc.
David K. Elder
David K. Elder
Greenleaf Health
Andrea Goddard
Andrea Goddard
Roche Pharma Technical Operations
Sean McEwen
Sean McEwen
AbbVie Inc.
Douglas R. Throckmorton
Douglas R. Throckmorton
Guy Villax
Guy Villax

Learning Objectives

At the completion of this conference, participants will gain skills to:

  • Conduct successful investigations of Out-of-Specification (OOS)/Out-of-Trend (OOT) findings
  • Effectively implement data integrity remediation
  • Establish robust processes and maintain state of controls
  • Improve product availability and avoid shortages
  • Manage post-approval changes and change management processes
  • Successfully implement quality management techniques and robust manufacturing
  • Update facilities to support dependable quality and supply

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

Registration Fees

Registration Type Price
Member $1916
Non-member $2139
Young Professional Member $958
Student Member $224
Student Non-Member $248
Gov't/Health Auth./Academic Member $560
Gov't/Health Auth. Non-Member $560
Academic Non-Member $640

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