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2019 PDA/FDA Joint Regulatory Conference

2019 PDA/FDA Joint Regulatory Conference

Sep 16 - Sep 18, 2019
Washington, DC

Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision

  • Conference
  • The Americas
Program Highlights

Dr. Peter Marks, CBER, U.S. FDA, has been confirmed as a regulatory keynote speaker at the 2019 PDA/FDA Joint Regulatory Conference.

Dr. Marschall S. Runge, Dean of the University of Michigan Medical School, and Louis Schmukler, SVP & President, Global Product Development and Supply, Bristol-Myers Squibb, will also provide keynote presentations during the Conference.

Join them and other leaders in medical product manufacturing, including more than 50 regulators from the FDA and MHRA at this premier pharmaceutical quality event!


The Parenteral Drug Association (PDA) and the U.S. FDA are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, now in its 28th 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 compliance issues in an ever-evolving landscape.

This year’s theme is Manufacturing Innovation, Quality, and Compliance: Achieving 20/20 Vision, and the Conference will explore the continuing development of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. Plenary and concurrent sessions will delve into the details through the assessment of the latest innovative technologies, regulatory expectations, and forward-looking perspectives, including:

  • CGMP challenges associated with cell and gene therapies
  • Combination products and connected care applications
  • Compliance updates and case studies
  • Data integrity remediation and an update on the associated PDA Technical Report
  • Designing aseptic processes to reduce quality risk
  • Effective internal and external audits
  • Evolving approaches to quality management systems
  • Improving deviation and failure investigations
  • Strategies for continuous improvement of facilities and equipment
  • Use of augmented reality and artificial intelligence in manufacturing

This year’s Conference will focus on how advances in manufacturing, quality, and compliance are advancing the continued supply of innovative drugs, biologics, and combination products. Collaborative efforts between industry and regulators are necessary to assure uninterrupted supplies of safe and high-quality products while advancing the use of new capabilities.

Attendees will also learn about hot topics, such as inspection updates, laboratory controls, rapid microbiological methods, optimizing regulatory submissions, conducting effective smoke studies, and quality trending. Multiple interest groups will meet to discuss in-depth regulatory and compliance issues.

The Center Updates – the traditional FDA presentations from each of the medical product Centers – will return this year. Here, senior officials from the FDA will discuss Center-specific initiatives and provide compliance updates. The new Lunch with the Regulators (formerly Breakfast with the Regulators) session will provide an opportunity for attendees to ask their most pressing regulatory and compliance issues.

The lineup of speakers also includes regulators from agencies around the world and industry leaders who will explore the global regulatory issues facing industry.


  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Sunday, September 15

    9:00 a.m. – 4:00 p.m. | MSOP Steering Committee (Invitation Only)

    12:00 p.m. – 1:00 p.m. | Advisory Board and MSOP Steering Committee Mix and Mingle (Invitation Only)

    1:00 p.m. – 5:00 p.m. | Biopharmaceutical Advisory Board (BioAB) (Invitation Only)

    1:00 p.m. – 5:00 p.m. | Regulatory Affairs/Quality Advisory Board (RAQAB) (Invitation Only)

    1:00 p.m. – 5:00 p.m. | Science Advisory Board (SAB) (Invitation Only)

    3:00 p.m. – 6:00 p.m. | Registration Open

    5:00 p.m. – 6:00 p.m. | PDA/FDA Program Planning Committee (Invitation Only)               

    5:30 p.m. – 7:00 p.m. | Interest Groups Leadership Dinner (Invitation Only)
  • Monday, September 16

    7:00 a.m. – 5:30 p.m. | Registration Open

    7:00 a.m. – 8:00 a.m. | Continental Breakfast

    7:00 a.m. – 8:00 a.m. | PDA Orientation Breakfast (Invitation Only)
    Supported in part by

    8:00 a.m. – 10:00 a.m. | P1: Manufacturing Innovation and Achieving the 20/20 Vision
    Moderator: David J. Jaworski, MBA, Senior Policy Advisor, CDER, U.S. FDA

    At this conference in 2009, U.S. FDA discussed its role as a public health agency which is focused on prevention of quality problems using the best available science, quality risk management, and enhanced transparency to inform the public. In the last 10 years industry, and U.S. FDA have worked together to forge the concepts discussed in 2009 into actions that are now having a positive impact on medical product quality. Today we set the stage to discuss ideas and strategies that we can use to establish our quality vision for 2020.

    U.S. FDA and industry will discuss several key initiatives to advance innovation; the quality of biologics, devices, and drugs; competition; and promote public health. U.S. FDA leadership will discuss implementation of the U.S. FDA’s Strategic Policy Roadmap and 21st Century Cures Act, and top management’s ongoing responsibility to assure quality by understanding sources of variation and improving their manufacturing operations. Industry leadership will explore the continuing evolution of innovative manufacturing capabilities, lifecycle knowledge management, and maximizing human potential within their companies. They will discuss how these innovations can drive paradigm shifts in quality assurance and compliance that lead to exceptional patient outcomes. These thought-provoking presentations will provide the strategic thinking that has enabled companies to leverage innovation to yield high quality medical products.

    8:00 a.m. | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
    John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC
    Rebecca A. Devine, PhD, Biopharmaceutical Consultant
    David J. Jaworski, MBA, Senior Policy Advisor, CDER, U.S. FDA
    Richard M. Johnson, President and CEO, PDA

    8:30 a.m. | Innovative Therapies in Health Care: Efficacy, Safety, and Speed to Market vs. High Cost and Profiteering
    Marschall S. Runge, MD, PhD, Executive Vice President for Medical Affairs & Dean, University of Michigan

    9:00 a.m. | Advancing Drug Innovation through Investment in Quality
    Patrizia Cavazzoni, MD, Deputy Director for Operations, CDER, U.S. FDA

    9:30 a.m. | Q&A Panel

    10:00 a.m. – 10:45 a.m. | Refreshment Break in Exhibit Area

    10:10 a.m. – 10:40 a.m. | Press Conference (Invitation Only)

    10:45 a.m.-12:15 p.m. | P2: Learning from Failures to Implement Sustainable CAPAs
    Moderator: Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA

    An effective quality system uses knowledge and manages risks to enable sound lifecycle decision-making. This lifecycle approach to quality management assures an ongoing state of control. When there are signals of inconsistent manufacturing operations, senior managers are responsible for driving robust fixes that prove to be sustainable in the long term. Corrective and Preventive Actions (CAPAs) can include facility, process, material, product, people or other improvements. Often, for a CAPA to be sustainable, upgrades in design are necessary. Some organizations do not take this important step. In this session, senior industry leaders will discuss how effective systems create the environment for a learning organization to optimize use of accumulated information in their decision-making and implement solutions that leverage today’s technology.

    10:45 a.m. | Global Quality in Takeda: Transformation, Integration, and Innovation
    Gerard Greco, PhD,
    Global Quality Officer, Takeda

    11:15 a.m. | A Lifecycle Approach to Quality Excellence
    Jackie Elbonne, SVP Global Quality and Chief Quality Officer, Bristol-Myers Squibb

    11:45 a.m. | Q&A Panel with Additional Panelist
    Ronan Farrell, PhD, Head of Global Quality and Compliance, Roche/Genentech

    12:15 p.m. – 1:45 p.m. | Chapter Council Meeting (Invitation Only)

    12:30 p.m. – 1:30 p.m. | Concurrent Interest Group Sessions 
    Boxed lunches will be provided for those that are participating in Interest Groups.

    IG1: Pharmacopeial

    Leaders: Anette Yan Marcussen, Managing Consultant, NNE A/S and Janeen Skutnik Wilkinson, Associate Director for Quality Intelligence, Biogen

    This session will provide participants with the latest updates from USP on standards for biologics/cell and gene therapy as week as USP’s commitment to early engagement of stakeholders.

    Speaker: Fouad Atouf, PhD, Vice President, Global Biologics, USP

    IG2: Quality Systems

    Leaders: Pia Lise Sandau, Corporate QMS Expert, Novo Nordisk A/S and Eva M. Urban, MSc, Director, Quality Risk Management, CSL Behring

    This session will provide an overview of the current discussions within the IG. In particular, the key messages from the sub-working groups will be outlined to attendees.

    Speaker: Cledwyn L. Davies, PhD, CChem, CSci, MRSC, Compliance Specialist, Qualified Person, Porton Biopharma Ltd

    IG3: Technology Transfer

    Leader: Beth J. Haas, MChE, Principal Consultant, CAI

    This IG has developed a novel tool to guide project management of technology transfers which is being incorporated into a new TR which will complement TR65. The session will be an introduction to the aspects of the new TR and will focus on the requirements for technology transfer supporting clinical phase 1-3 with key differences and similarities identified using the defined grid-style approach.

    Speaker: Derek R. Gallo, BS, Director, Technology Transfer, Thermo Fisher Scientific

    IG4: Vaccines

    Leaders: Jane L. Halpern, PhD, Independent Consultant and A. Sabrina Restrepo, PhD, Director, Global Vaccines Technical Operations, Merck & Co., Inc.

    This IG will include a working session to further develop the planned Technical Report (Vaccine Control Strategies) and a speaker who will cover 2 of the 4 conference tracks – 1) Innovation and Technology, and 2) Lifecycle Implementation.

    1:45 p.m. – 3:15 p.m. | Concurrent Sessions


    A1: Quality Considerations for Connected Care and Devices
    Moderator: Valerie Whelan, BSc, Vice President, Head of R&D Quality and Compliance, Amgen Inc.

    As big a part as technology and innovation are playing in the development and manufacture of pharmaceutical and biotechnology products, they are arguably playing a more rapidly evolving part in the experience of patients in how their medicines are administered, how their diseases are managed, and the novel ways that they can record and provide feedback on performance.

    Are our traditional quality management systems and regulations suitably equipped to adapt to this changing landscape? What have we learned to better equip us all to be successful in this space and continue to rapidly adapt?

    1:45 p.m. | Quality Considerations for Connected Care and Devices
    John F. Murray, Jr.,
    Partner, Consultant, SoftwareCPR and Carl Washburn, MBA, Senior Consultant, Digital Quality, Eli Lilly and Company 

    2:45 p.m. | Q&A Panel with Additional Panelist
    Michelle R. Harris,
    Corporate Development Officer, American Diabetes Association 


    B1: Current Compliance Issues and Case Studies
    Moderator: David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

    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.

    1:45 p.m. | CDER GMP Compliance Update
    Rick L. Friedman, MS,
    Deputy Director OMQ, CDER, U.S. FDA

    2:15 p.m. | CBER Compliance Update
    Maria C. Anderson,
    Branch Chief, Biological Drug and Device Compliance Branch, CBER, U.S. FDA

    2:45 p.m. | Q&A Panel with Additional Panelists
    John W. Diehl, MS, Director, Compliance Branch, ORA, U.S. FDA 
    Marea K. Harmon, Consumer Safety Officer, CVM, U.S. FDA


    C1: Quality by Design Lessons Learned and Where We are Now
    Moderator: Bita Mirzai-Azarm, MS, Branch Chief, CDER, U.S. FDA

    The objective of this session is to focus on the quality by design (QbD) for parenteral drugs and how it can be used to ensure the desired quality, safety and efficacy of the product in line with the product label claim, with an emphasis on case studies such as extended release injection suspension packaged in pre-filled syringe and injection solution in IV bags. The session also aims to identify gaps in the understanding of QbD between industry and U.S. FDA and further improve collaboration by providing regulatory feedback and industry’s experience on commonly observed deficiencies.

    1:45 p.m. | Applying Quality by Design to Parenteral Drug Products
    Kiran Krishnan, PhD,
    Senior Vice President, Global Regulatory Affairs, Apotex

    2:15 p.m. | Regulatory Requirements: A Design Element to Ensure Quality
    Reynold Tan, PhD,
    Chemist, CDER, U.S. FDA

    2:45 p.m. | Q&A Panel

    3:15 p.m. – 4:00 p.m. | Refreshment Break in Exhibit Area

    4:00 p.m. – 5:30 p.m. | Concurrent Sessions


    A2: Augmented Reality and Artificial Intelligence: Conceptualization through Implementation
    Moderator: Sharyl D. Hartsock, Senior Director Quality, Global Quality Systems, Eli Lilly and Company

    The digital transformation of pharma is happening at an accelerating pace and many companies are beginning to realize the potential for improved control, higher equipment reliability, and enhanced human understanding of complex process variable interactions. New technologies, like augmented reality (AR) and artificial intelligence (AI), continue to drive innovation within this space. This session will explore learnings from current and proposed application of augmented reality and artificial intelligence use cases with the intent to aid others in acceleration and realization of the benefits of more advance technologies and approaches. Industry speakers will describe their technology journeys from concept through implementation, highlighting several successful (AR/AI) use cases and how this work fits into the bigger picture of “Pharma 4.0” factory of the future.

    4:00 p.m. | Artificial Intelligence in a Manufacturing Environment
    Bob Bowden, PhD, Senior Director, Cell Collection, Advanced Therapeutics Supply Chain, Johnson and Johnson

    4:30 p.m. | Connected Health: A Case Study in User Centered Digital Design
    Jasper Benke,
    Vice President, RA/QA/CA, Companion Medical, Inc.

    5:00 p.m. | Q&A Panel with Additional Panelists
    David J. Jaworski, MBA, Senior Policy Advisor, CDER, U.S. FDA
    Sean Saint, Chief Executive Officer, Companion Medical, Inc.


    B2: Facility Lifecycle
    Moderator: David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

    A manufacturer must manage each of its facilities to ensure equipment, processes, and the overall building remain robust. As part of a self-inspection program, it is important to have a detailed and hands-on inspection of the facility and equipment that involves appropriate SMEs, including the quality unit. This can reveal and assess the suitability of the plant and highlights areas needing mitigation and should drive pro-active improvements throughout the facility lifecycle. This includes appropriate investment in facility upgrades and process improvements that are part of the evolution of any manufacturing enterprise. This session will share an example approach that is used within a company. Also, U.S. FDA will reinforce the reasons why robust equipment and facilities are so critical to assuring quality, and advantages of leveraging current technologies in CGMP facilities as part of a 2020 quality vision.

    4:00 p.m. | Facility Lifecycle: 1980s vs. 2020s Technology
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

    4:30 p.m. | Facility and Equipment Assessment to Ensure Microbial Control throughout the Lifecycle
    Cheryl E. Essex, MS, Head of Microbiological Control, Sanofi

    5:00 p.m. | Q&A Panel with Additional Panelists
    Hal Baseman, Chief Operations Officer, ValSource LLC
    Glenn E. Wright, Quality Head, Exelead BioPharma Inc.


    C2: Applying Phase Appropriate GMP: How to Approach Application of GMP for Expedited Programs
    Moderator: Nicole Trudel, Quality Assurance Lead, DMPQ, CBER, U.S. FDA

    This session will focus on GMP requirements that should be considered early in product development. Topics will include the design of clinical production facilities in order to meet future production goals and the associated GMPs, transitioning from Phase III to approval, and manufacturing challenges associated with personalized medicine, small and/or virtual companies, and fast-track/breakthrough approval cycles.

    4:00 p.m. | Phase Appropriate GMPS in Investigational New Drug (IND) Manufacturing
    Anthony F. Lorenzo,
    Lead Consumer Safety Officer, CBER, U.S. FDA

    4:30 p.m. | GMP for ATMP: Comparing US and EU Requirements
    Keith Wonnacott,
    Executive Director, Regulatory Affairs, Pfizer

    5:00 p.m. | Q&A Panel with Additional Panelists
    Jeffrey C. Baker, PhD, Deputy Director, Office of Biotechnology Products, CDER, U.S. FDA
    Carolyn Renshaw, Branch Chief, CBER, U.S. FDA (INVITED)

    5:45 p.m. – 6:45 p.m.
    Concurrent Interest Group Sessions

    IG5: Combination Products

    Leader: Lee H. Leichter, MBA, RAC, President, P/L Biomedical

    The challenge to combination product manufacturers has become how to continue to meet the ever-changing requirements within the regulatory process designed for drugs and biologics.

    This session will provide an overview of the activities within the industry and U.S. FDA to balance the needs for flexibility and innovation while balancing the need for oversight ingrained within the drug approval process.

    Speaker: Suzette M. Roan, JD, Senior Director, GRA Devices, Sanofi

    IG6: Facilities and Engineering and QRM

    Facilities and Engineering Leader: Shelley M. Preslar, MBA, PMP, General Manager, Azzur Group Raleigh 
    Quality Risk Management Leader: Eva M. Urban, MSc, Director, Quality Risk Management, CSL Behring 

    This combined IG session will draw upon a case study to explore the ways that QRM is used to enable the evolving manufacturing conditions across the industry

    Speaker: John Kutney, Director, Manufacturing, Novavax, Inc

    IG7: GMP Links to Pharmacovigilance

    Leader: John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    USP general chapters <787> and <788> provide that parenteral products for which the labeling specifies use of a final filter prior to administration are exempt from the requirements of those chapters, provided that scientific data are available to justify this exemption. 

    In the past few years some studies suggest that the use of in-line filters may decrease morbidity in certain clinical situations. Seizing on this data, some commentators have urged routine utilization of bedside in-line filtration independent of the particle counts found in the final product.

    This session will explore the application of the USP exemptions and the scientific evidence sufficient to justify its adoption. In addition, the much broader recommendation for employing the use of a filter for every intravenous infusion and the applicable cGMP elements concerning filter selection and qualification will be discussed.

    Speaker: CAPT Uduak M. Inokon, PharmD, MA,
    Program Management, OPQ, CDER, U.S. FDA

    IG8: Process Validation

    Leader: Scott R.  Bozzone, PhD, MS, Principal, Pharm Lifecycle Validation LLC

    This IG will cover both quality and compliance and innovation in process validation with a presentation on Example of Tablet Sampling Plan and Alternate Statistical Criteria to USP <905> Compendia - A Case Study in Process Validation; and update and brief summary and open discussion on PDA initiatives: Continued/On-going Process Verification (CPV)- technical report and latest information on this Stage 3 of the PV lifecycle; and a cleaning validation update on the Technical Report 29 revision and latest information on regulatory aspects of cleaning validation.        

    Speaker: Maria M. Diaz-Cabrera, BS, Quality Systems & Compliance - Validation Senior Manager, Pfizer

    IG9: Sterile Processing

    Leader: Rebecca A. Brewer, Vice President of Strategic Practices, Quality Executive Partners

    Evolving the expectations for aseptic process simulations is required to keep pace with technology. Combination products, cell and gene therapy, innovations in isolator technology, continuous manufacturing, factories of the future – what impact are they having today on the concepts and requirements for aseptic process simulation and what does the future hold? What changes do we need to current regulation and guidance on aseptic processing to keep pace? What tools require investment by industry to improve confidence in our results (from what is commonly manual visual inspection), methods to streamline inspection, and to enhance documentation?

    Speakers: Hal Baseman, MBA, Chief Operating Officer, ValSource LLC and Rebecca E. Dombrowski, MS, Senior Policy Advisor, U.S. FDA 

    IG10: Visual Inspection of Parenterals

    Leaders: John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC and Rick J. Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.

    Visual inspection continues to be a critical part of the manufacturing and quality control process. This session will review the recent US and EU guidance changes and their impact on routine visual inspection processes. Inspection technology is also changing and the use of artificial intelligence and deep learning pose both opportunities for improved inspection performance as well as challenges to validation and regulatory compliance. This session will discuss current experience and possible strategies for effective implementation of these exciting new tools as well as challenges and opportunities in the visual inspection field and an opportunity to share current experiences.

    7:00 p.m. – 10:00 p.m. | Networking Reception

  • Tuesday, September 17

    7:00 a.m. – 6:30 p.m. | Registration Open

    7:00 a.m. – 8:30 a.m. | Continental Breakfast

    7:15 a.m. – 8:15 a.m. | Concurrent Breakfast Sessions

    Breakfast 1: Rapid Microbiology
    Moderator: Clarice Hutchens, PhD, MA, DM, Senior Director, Pfizer

    Rapid microbiological methods can facilitate timely monitoring and release, and support innovation. In this session, participants will learn how to overcome roadblocks through case studies of applications in environmental monitoring, in-process testing, continuous manufacturing, and cell and gene therapy. Compendia status and regulatory expectations regarding data integrity, validation, and implementation (e.g., real time release testing) will be presented.    

    7:15 a.m. | Coevolution of Rapid Micro Methods and Pharmacopeia Requirements
    David L. Jones, PhD, 
    Director, Rapid Micro Biosystems

    7:45 a.m. | Q&A Panel with Additional Panelists
    Candace Gomez-Broughton, Microbiologist, CDER, U.S. FDA
    Ed C. Tidswell, PhD, BSc, Executive Director QA, Merck & Co., Inc.

    Breakfast 2: Optimizing Small and Medium Lot Cleanroom Practices
    Moderator: Enrique Diloné, PhD, RAC, Senior Vice President, Technical Operations, Amicus Therapeutics

    The products made by any pharmaceutical or biopharmaceutical manufacturer may be subject to “manipulation” by a compounding pharmacy or any hospital pharmacy prior to being administered to the patient. Some of these organizations range from very sophisticated clean room and aseptic operations managed by well operated 503B compounding pharmacies and teaching hospitals, to small 503A compounding pharmacies and small regional hospitals that may compound only sporadically. This breakfast session will present what you can do to support these organizations to reduce risk to your product.

    7:15 a.m. | What Can We Learn from Compounding Pharmacy Producing Small Parenteral Batches?
    Chris J. Smalley, PhD, Compounding Pharmacist Advisor, ValSource, LLC

    7:45 a.m. | Q&A Panel with Additional Panelist
    Ian F. Deveau, PhD, Division Director (Acting), CDER, U.S. FDA

    Breakfast 3: Regulatory Reporting
    Moderator: Paul Perdue, Jr., Branch Director, ORA, U.S. FDA

    In this session, we will discuss what must be reported when submitting Field Alert Reports (FARs), Biological Product Deviation Reports (BPDRs) and MedWatch Reports. In addition, this session will discuss case studies demonstrating the agency expectations regarding the interpretation of the regulation and clear examples of when FARs, BPDRs, and MedWatch Reports should be reported.

    7:15 a.m. | Field Alert Reports
    Elise A. Murphy, Supervisory Consumer Safety, CDER, U.S. FDA

    7:35 a.m. | Biological Product Deviation Reports
    Kimberly E. Rains, PharmD, Associate Director for Regulatory Affairs, CDER, U.S. FDA

    7:55 a.m. | Q&A Panel

    Breakfast 4: Quality Systems: Preventing Quality and Shortage Issues
    Moderator:Douglas A. Campbell, Senior Consultant, InterPro QRA

    The last several years have been consumed with discussions and events designed to raise awareness and raise a call for action to reduce drug shortages. It is clear that Industry and the U.S. FDA must continue to be proactive to reduce the cause and effects of drug shortages. This session will provide a brief update on the Drug Shortage Task Force. In addition, this session will provide input and insights related to how establishing an effective quality system will enable your company to better manage its day-to-day operations and emergencies, while also providing controls to better manage the supply of products to the market.

    7:15 a.m. | Quality Systems
    Jeannie C. David, MS,
    Senior Program Management Officer, CDER, U.S. FDA

    7:45 a.m. | Q&A Panel with Additional Panelist
    Glenn E. Wright,
    Quality Head, Exelead BioPharma Inc.

    Breakfast 5: Data Integrity
    Moderator: Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc.

    The PDA Data Integrity Task Force has been working on a series of technical reports (TRs) addressing data integrity. The most recent TR is focused on data integrity issues related to manufacturing/shop floor systems and processes. A risk-based approached for identification of appropriate data integrity controls and implementation mitigations are the core concepts described in this report. This session will be the first opportunity for PDA members to get an inside look at some of the information and recommendations contained in this draft TR. This session will also include a panel discussion with members from the team that wrote the technical report and will be a great opportunity for PDA members to ask questions regarding the thought process behind the recommendations contained in the report.

    7:15 a.m. | PDA Tech Report: Integrating Data Integrity Requirements into Manufacturing and Packaging Operations
    Els Poff, Executive Director, Data Integrity Center of Excellence, Merck & Co., Inc. and PDA Data Integrity Technical Report Leader

    7:45 a.m. | Q&A Panel with Additional Panelist 
    Maan S. Abduldayem,
    Supervisory Consumer Safety, CDER, U.S. FDA

    8:30 a.m.-10:00 a.m.
    P3: Compliance Updates
    Moderator:John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    Featuring Compliance Directors from the U.S. FDA Centers and Office of Regulatory Affairs/Office of Enforcement, Director, 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.

    8:30 a.m. | Panel Discussion
    CDR John W. Diehl, MS, Director, Compliance Branch, ORA, U.S. FDA
    Martine L. Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance, CVM, U.S. FDA
    Michael Levy, JD, Deputy Director for Policy and Analysis, Office of Compliance, CDER, U.S. FDA
    Melissa J. Mendoza, JD, Deputy Director, Office of Compliance and Biologics Quality, CBER, U.S. FDA

    10:00 a.m. – 10:45 a.m. | Refreshment Break and Passport Drawing in Exhibit Area

    10:45 a.m. – 12:15 p.m. | Concurrent Sessions


    A3: Innovations in Aseptic Processing
    Shane D. Killian, MS, Senior Director, Licensing, Acquisition & Early Development, Janssen R&D Quality & Compliance and Lynnsey A. Renn, PhD, Public Health Analyst, Office of Manufacturing Quality, CDER, U.S. FDA

    Manufacturing innovation is key to aseptic filling of sterile drug products. Automation can minimize risk to exposed products by reducing operator interventions. This session will discuss new/modern approaches to aseptic processing, such as robotics, and the benefits of technological advances in drug manufacturing.

    10:45 a.m. | Innovations in Aseptic Processing: Opportunities and Challenges in Implementing Next Generation Technologies
    Chakradhar Padala, PhD,
    Director, Process Development, Amgen Inc.

    11:15 a.m. | A Regulatory Perspective on Innovations in Aseptic Processing
    Bryan S. Riley,
    Supervisory Microbiologist, CDER, U.S. FDA

    11:45 a.m. | Q&A Panel with Additional Panelist
    Hal S.Baseman,
    Chief Operations Officer, ValSource, LLC


    B3: Quality Systems: Focus on Change Management Program
    Rebecca A. Devine, PhD, Biopharmaceutical Consultant

    Managing post-approval changes (PAC) is a challenging prospect in today’s global environment. With Life Cycle Management for Pharmaceuticals as outlined in the draft ICH Q12, the implementation of an effective change management process for regulatory filings will be important. An effective pharmaceutical quality system (PQS) will be key for implementing changes that do not have to be reported prior to implementation. This session will focus on the expectations for life cycle management, the PQS, and the risk-based approaches to PAC management. The session will cover perspectives from regulators, expectations for the PQS, and practical examples of effective PAC management from industry.

    10:45 a.m. | Managing Post-Approval Changes in a Global Regulatory Environment
    Rebecca A. Devine, PhD,
    Biopharmaceutical Consultant

    11:15 a.m. | Effective Change Management in the Q12 Paradigm
    Ileana Barreto-Pettit, RN, MPH,
    Captain, U.S. Public Health Service, Drug National Expert, ORA, U.S. FDA

    11:45 a.m. | Q&A Panel with Additional Panelists
    Sharyl D. Hartsock,
    Senior Director Quality, Global Quality Systems, Eli Lilly and Company
    Chikako Torigoe,
    Biologist, CBER, U.S. FDA


    C3: The New Inspection Paradigm
    Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA

    How can drug inspection be improved? Based on feedback received throughout the last few years, the U.S. FDA has developed a new inspection paradigm in response to globalization, and ongoing effort to encourage manufacturing quality at regulated pharmaceutical facilities. In addition to learning the new paradigm, this session will also provide attendees insight to U.S. FDA’s current thinking how a facility can best develop an effective response to U.S. FDA Form 483 Inspectional Observations.

    10:45 a.m. | Current Activities with the U.S. FDA/EU Mutual Recognition Agreement
    David M. Churchward, MSc,
    Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA, UK

    11:05 a.m. | Pilot Program: The New Inspection Protocols Project (NIPP)
    Rosa J. Motta,
    Supervisory Consumer Safety, CDER, U.S. FDA

    11:25 a.m. | Responding to U.S. FDA Form 483
    David J. Jaworski, MBA,
    Senior Policy Advisor, CDER, U.S. FDA

    11:45 a.m. | Q&A Panel with Additional Panelists
    Laura Huffman, MS,
    Master Microbiology Reviewer, CVM, U.S. FDA
    Nicholas A. Violand, Consumer Safety Officer, ORA, U.S. FDA

    12:15 p.m. – 1:45 p.m. | Portfolio Steering Committee (Invitation Only)

    12:30 p.m. – 1:30 p.m.
    Concurrent Lunch Sessions with the Regulators

    Back by popular demand and at a new time! 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.

    Review-Based Panel Discussion
    Moderators: Rebecca A. Devine, PhD, Biopharmaceutical Consultant, Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA, and Bita Mirzai-Azarm, MS, Branch Chief, CDER, U.S. FDA

    Renée S. Blosser, MS, Microbiologist, CVM, U.S. FDA
    Bing Cai, PhD, Division Director, CDER, U.S. FDA
    Zhihzo Peter Qiu, PhD, Chief, Biotechnology Manufacturing Assessment Branch, CDER, U.S. FDA
    Ramesh Raghavachari,
    Supervisory Chemist, CDER, U.S. FDA
    Derek S. Smith, Supervisory Chemist, CDER, U.S. FDA

    Inspection-Based Panel Discussion
    Moderators: Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc., Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc, and Valerie Whelan, BSc, Vice President, Head of R&D Quality and Compliance, Amgen Inc.

    David M. Churchward, MSc, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA, UK
    Marea K. Harmon, Consumer Safety Officer, CVM, U.S. FDA
    Brooke K. Higgins, MS,
    Senior Policy Advisor, CDER, U.S. FDA
    Jose E. Melendez,Drug National Expert, ORA, U.S. FDA
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

    1:45 p.m. – 3:15 p.m. | Concurrent Sessions


    A4: Continuous Manufacturing Update
    Moderator:Clarice Hutchens, PhD, MA, DM, Senior Director, Pfizer

    ICH released a concept paper that outlines the content for the guidance “ICHQ13: Continuous Manufacturing of Drug Substances and Drug Products” with a scope of small molecules and therapeutic proteins. U.S. FDA released a draft guidance entitled “Quality Considerations for Continuous Manufacturing Guidance for Industry” with a scope of small molecule, solid oral drug products that are regulated by CDER. Learn how ICH and U.S. FDA guidances are developing with similarities and differences noted. The roles of USP, EP, ASTM, and academia will be highlighted. Industry and regulators will present continuous manufacturing case studies to include experiences in working with the Emerging Technology Team.    

    1:45 p.m. | ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products
    Ganapathy Mohan, PhD, Executive Director, Merck & Co., Inc.

    2:10 p.m. | Regulatory Perspective on Continuous Manufacturing
    Sharmista Chatterjee,
    Supervisory Chemist, CDER, U.S. FDA

    2:35 p.m. | Industrial Experience in the Application of Continuous Manufacturing (CM) for an Oral Solid Dosage Form
    David Pappa,
    Director of Technical Services/Manufacturing Science, Eli Lilly and Company

    3:00 p.m. | Q&A Panel


    B4: Investigations: Quality Risk Management and Structured Investigational Approaches
    Moderator: Rebecca E. Dombrowski, MS, Senior Policy Advisor, CDER, U.S. FDA

    Investigations into failures, discrepancies, and unplanned events are integral to root cause understanding and risk management, including both internal investigations and those associated with contracted organizations. This session will examine various structured approaches, systems, and methods available as part of an effective investigation to determine the root cause(s) of a discrepancy, failure, or unplanned event. Complex case studies demonstrating true root cause determination(s) and lessons learned, as well as operational phases of corrective action/preventative action implementation, through effectiveness assessments, will be presented.

    1:45 p.m. | QRM and Structured Investigational Approaches: Industry Experience
    Wallace Torres,
    Executive Director, Quality, Amgen

    2:05 p.m. | Deviation Investigations
    Kevin M. Jenkins, BS, MBA,
    Vice President, Sterile Injectables Quality, Pfizer

    2:25 p.m. | The Art of a Quality Investigation
    Binh T. Nguyen, PharmD,
    Consumer Safety Officer, CDER, U.S. FDA

    2:45 p.m. | Q&A Panel


    C4: How Effective Is Your Audit Program?
    Moderators: Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc

    A good audit program should integrate information from regulatory, client, internal and supplier audits to offer a holistic view of your operations. This session will focus on the various types of audits that constitute an audit program, tracking and aligning the information from the various audits to ensure continued improvement and consistency across your operation and how to communicate those improvements to regulatory authorities and clients.

    1:45 p.m. | Effectiveness of Auditing Program
    Ghada N. Haddad, MBA,
    Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

    2:15 p.m. | Small/Start Up Company Perspective
    Guy Villax
    , CEO, Hovione

    2:45 p.m. | Q&A Panel with Additional Panelist
    David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

    3:15 p.m. – 4:00 p.m. | Refreshment Break and Passport Drawing in Exhibit Area

    4:00 p.m. – 5:30 p.m. | Concurrent Sessions


    A5: Cell and Gene Therapy: CMC Considerations
    Moderator: Carol L. Rehkopf, Chief, Review Management Business Operations Staff, CBER, U.S. FDA

    Cell and gene therapy products bring much promise to patients suffering rare or serious life-threatening diseases but getting them to market at large scale proves challenging. This session will discuss the chemistry manufacturing and control (CMC) considerations to prepare for successful U.S. FDA approval and launch to market. The speakers of this session have first-hand experience with regulatory expectations and industry challenges and they will share their tips for success.

    4:00 p.m. | CMC Considerations for Gene Therapy Product Development
    Lilia L. Bi, PhD,
    CMC Reviewer, CBER, U.S. FDA

    4:30 p.m. | Gene Therapy: The Road from IND to BLA
    Paul J. Gil, PhD,
    Executive Director, Regulatory Affairs CMC Gene Therapy, Amicus Therapeutics, Inc.

    5:00 p.m. | Q&A Panel


    B5: OOS and Effective Remediation: Chemical and Microbiological
    Moderator: Renée D. Kyro, MBA, Director, AbbVie

    It’s been 26 years since the landmark case of Barr Laboratories vs. USA set the standard for all Out of Specification (OOS) investigations. Has our industry truly integrated and maintained the lessons learned from this case? Or with the passage of time, has history been forgotten and appropriate laboratory practices altered? Is the laboratory automatically implicated in an OOS or do manufacturing and lab personnel work together to determine root cause and remediation? In this session, participants will hear industry case studies and best practices, along with the U.S. FDA’s perspective on current laboratory OOS inspection observations.

    4:00 p.m. | Inspection Observations
    Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA

    4:30 p.m. | Investigation Case Studies
    Sean McEwen, Vice President, Quality Assurance, Abbvie Operations, Abbvie

    5:00 p.m. | Q&A Panel with Additional Panelist
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA


    C5: The Value of Selecting the Right Consultant
    Moderators:Rebecca A. Devine, PhD, Biopharmaceutical Consultant and Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc

    Companies hire consultants for many reasons. Sometimes consultants are hired to perform staff activities, to prepare strategic plans for continuous improvements, to help with maintenance or re-qualification activities, or to help with preparing necessary reports for regulatory filings. However, the most prevalent reason companies hire consultants is to help them avoid serious regulatory actions because they behaved in an un-compliant or questionable manner.

    In these situations, the client often doesn’t take the time to properly vet the consultant they chose and often end up with consultants that don’t fit their culture or meet their expectations. This session will focus on how to choose a consultant that meets your needs, is capable of delivering your project, and will work well with your organization.

    4:00 p.m. | Considerations and Regulatory Background for Selecting Consultants
    Tamara L. Ely,
    Consumer Safety Officer, CDER, U.S. FDA

    4:30 p.m. | The Importance of Selecting the Right Consultant
    Anil Sawant, PhD, MSc,
    Senior Vice President, Global Quality Compliance, Merck & Co., Inc.

    5:00 p.m. | Q&A Panel with Additional Panelists
    Douglas A. Campbell, Senior Consultant, InterPro QRA
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    5:45 p.m. – 6:45 p.m. | Concurrent Interest Group Sessions

    IG11: Filtration

    Leader: Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing, Inc.

    This session will update participants on the PDA/BPOG SFQRM (Sterile Filtration Quality Risk Management) (Pre-Use Post-Sterilization Integrity Testing (PUPSIT)) initiative, its work, and results. The initiative’s four workstreams will be discussed. It will also address the interaction the task group has with the European regulatory authorities and the work together with them.

    IG12: Inspection Trends

    Leader: Christopher S. Carter, Director, Quality Assurance & Regulatory Affairs, Owens & Minor

    Europe and Britain agreed to new deadline of October 31, 2019 for Brexit implementation. Brexit was initially schedule for March 29. This session will discuss the impact of Brexit from EMA and MHRA perspectives, on Pharma industry, in terms of regulatory requirements.

    IG13: Lyophilization and Packaging Science

    Lyophilization Leader: Edward H. Trappler, President, Lyophilization Technology, Inc.
    Packaging Science Leader: Roger P. Asselta, BS, Vice President, Technical Affairs, Genesis Packaging Technologies

    Glass/product interactions and vial breakage continue to be a focus of attention within the industry. In particular, vial breakage and the risk of glass contamination of surrounding product is a prominent concern. The session will open with highlights on recent discussions and highlights from the PDA Glass Conference held in January 2018. This IG will then be an open forum for discussions on these and other current topics in packaging for both liquid products and lyophilized preparations. 

    In this open forum, topics are identified by participants, then prioritized by voting, reflecting the level of interest for discussion by the group. 

    IG14: Prefilled Syringes

    Leader: Olivia A. Henderson, PhD, Principal Engineer, Amgen, Inc.

    This will continue its series on glass alternatives. Alternative materials such as COC (cyclic olefin copolymer) or COP (cyclic olefin polymer) enable silicone oil-free syringe functionality thereby mitigating risk of potential harm to patients that could be caused by immunogenicity from protein-silicone oil interactions. Alternative materials are also sought after for use in syringes to improve dimensional tolerances and manufacturing capability, reduce dependency on silicone oil and reduce dependency on manufacturing materials such as tungsten and adhesives. This session will host a discussion of plastic syringe development challenges. 

    IG15: Regulatory Affairs

    Leader: Ruhi Ahmed, PhD, RAC, Vice President, Inozyme Pharma Inc.

    If the manufacturing team did not face issues or if they did not innovate throughout development (and often post-approval), many in quality and regulatory chemistry, manufacturing, and controls (CMC) would be bored out of their minds! However, sometimes the issues in product development and manufacturing stop being routine and enter the realm of being serious quality and compliance issues that could impact the continued development of the product. Many of us can benefit from a dialogue with the regulatory agencies to overcome serious challenges in CMC during drug development to ensure a safe and quality product for the market. This is particularly true for the CMC programs of novel therapies that are on the expedited approval pathways. This IG will host an interactive panel discussion with real world situations to illustrate and clarify the why, when, and how for requesting and conducting US or EMA regulatory agency meetings specifically for CMC/quality-related issues.

    Mo Heidaran, PhD, Vice President, Technical, Parexel International
    Don L. Henry, Acting Director, Office of Program and Regulatory Operations, OPQ, CDER, U.S. FDA

    IG16: Supply Chain Management

    Leaders: Lucy Cabral, Head Global Supplier Quality, Genentech, A Member of the Roche Group and Amelia (Amy) L. Mutere, MS, Head Global Quality Inspection Management, Genentech, a member of the Roche Group

    This IG will discuss innovation, quality, and compliance in supply chain management, including: 1) share best practices for meeting China and Russia pharmacopeia and Chinese regulatory Requirements, 2) supplier quality management of single-use systems and the different from the traditional supplier quality management (SQM) models (i.e., change control), and 3) supply chain management of cell gene therapies.

    Speaker: Bernd A. Kraemer, PhD, Head of Supplier Quality Management - Americas Region, Genentech, Inc. 

  • Wednesday, September 18

    7:00 a.m. – 12:00 p.m. | Registration Open

    7:00 a.m. – 8:30 a.m. | Continental Breakfast

    7:15 a.m. – 8:15 a.m. | Concurrent Breakfast Sessions

    Breakfast 6: Using Statistical Tools and Effective Statistical Control: Introduction to Statistical Process Control
    Jacqueline A. Kunzler, PhD, MBA, Senior Vice President, Chief Quality Officer, Baxter Healthcare Corporation

    Statistical process control (SPC) is one of many great tools in the tool bag that empowers an operator to make smart adjustments to the process, before the process produces out of specification limits. If used properly, SPC can also diagnose a process that is unstable (sick) and needs a healthy dose of maintenance or corrective action prescribed for the process. This session will briefly show the basics of SPC (statistics) but will focus primarily on lessons learned and highlight real world applications (process control).

    7:15 a.m. | Overview of Statistical Process Control
    Karthik B. Iyer,
    Supervisory Consumer Safety, CDER, U.S. FDA

    7:35 a.m. | Industry Case Study using Statistical Process Control
    Jayme D. Patterson,
    Senior Manager Operational Excellence, Baxter Healthcare Corporation

    7:55 a.m. | Q&A Panel

    Breakfast 7: Using Emerging Tools to Understand Post-Market Patients'/Consumers' Perspectives on Quality
    Neil A. Stiber, PhD, Associate Director for Science and Communication, Office of Surveillance, CDER, U.S. FDA

    Understanding the patient/consumer experience is key to evaluating post-market quality data. Conventional quality feedback mechanisms, including complaints, MedWatch, and adverse events, can be complemented by social media to more fully capture patient/consumer perspectives. Social media provide an innovative approach to explore patient perspectives that might otherwise remain unknown. Data and text analytics can integrate multiple data sources to discover and analyze trends and signals. The outcomes can improve future patient experiences.

    7:15 a.m. | Harnessing the Power of Social Listening and U.S. FDA Archival Data to Gain Insight into the Patient’s Experience
    Christine S. Lee, PhD, PharmD,
    Scientist, OC, U.S. FDA

    7:35 a.m. | User-Generated Web Data Predicts Quality Risk: Evidence from the Pharmaceutical Industry
    Hyunwoo Park,
    Assistant Professor, The Ohio State University

    7:55 a.m. | Q&A Panel

    Breakfast 8: Quality Culture
    Susan J. Schniepp, BS, Distinguished Fellow, Regulatory Compliance Associates Inc

    PDA has recognized the importance culture has on an organization since the first quality metrics meeting in 2014. The ability of an organization to manufacture products in a compliant manner depends on people’s behavior and management’s guidance. PDA quality culture/quality metrics task force has developed a quality culture assessment tool that maps quality behaviors to quality attributes. Members of the task force will be presenting one of the training modules from this tool so attendees can understand this relationship and how it can impact the overall company performance.

    7:15 a.m. | Quality Culture Role Play
    Cylia Chen-Ooi, MS,
    Director Quality External Affairs, Amgen Inc. and Member, PDA Quality Metrics Task Force
    Steve R. Mendivil, BS, Independent Consultant and Member, PDA Quality Metrics Task Force

    7:45 a.m. | Q&A Panel

    Breakfast 9: Aseptic Processing for Cell and Gene Therapy Products
    Moderator: Laurie P. Norwood, MS,
    President, Norwood Biologics Consulting LLC

    Production of cell and gene therapy products often requires aseptic processing from beginning to end. The manufacturing processes for these novel products do not always fit the usual paradigm of media fills for final finished drug product. This morning’s session will provide some insight on U.S. FDA’s expectations for media simulations for these non-traditional products as well as an industry case study on how to perform a risk assessment to support the steps to be included in such media simulations.

    7:15 a.m. | Regulatory Perspective on Aseptic Processing for Cell and Gene Therapy Products
    Lily Y. Koo, PhD,
    Consumer Safety Officer, CBER, U.S. FDA 

    7:45 a.m. | Q&A Panel

    Breakfast 10: Smoke Studies
    Lynnsey A. Renn, PhD, Public Health Analyst, Office of Manufacturing Quality, CDER, U.S. FDA

    Smoke studies are critical to understanding airflow in an aseptic area. Executing suitable smoke studies can be challenging. This session aims to provide information about how to design and conduct an effective smoke study, as well as, critique air patterns.

    7:15 a.m. | Airflow Visualization Techniques and Practices
    David K. Matsuhiro,
    Senior Consultant, Cleanroom Compliance, Inc.

    7:45 a.m. | Q&A Panel with Additional Panelists
    Tamara L. Ely,
    Consumer Safety Officer, CDER, U.S. FDA
    Jose E. Melendez, Drug National Expert, ORA, U.S. FDA

    8:30 a.m. – 10:00 a.m. | P4: Center Updates
    Moderator: Tina S. Morris, PhD, Vice President, Scientific and Regulatory Affairs, PDA

    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 ICH advancements to product quality while assuring the availability of high-quality medicines every day? Discuss these issues with senior management officials from various U.S. FDA Centers in this highly interactive session! In a roundtable 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.

    8:30 a.m. | Panel Discussion
    Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA
    Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA
    Steven M. Solomon, DVM, MPH, Director, CVM, U.S. FDA
    Douglas R. Throckmorton, MD, CDER Deputy Director of Regulatory Programs, CDER, U.S. FDA

    10:30 a.m. – 12:15 p.m. | P5: The Evolving Regulatory Landscape
    Moderator: John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    One of the great challenges related to innovation involves the capacity of the regulatory environment to be flexible enough to adapt yet explicit enough to provide clear-cut compliance guidance. To ensure manufacturing quality standards do not degrade, executive support for robust pharmaceutical development and manufacturing infrastructure upgrades are critical to promote meaningful advancements. Likewise, clear regulatory standards are equally important to ameliorate risk related to the uncertainty inherent in the use of innovative technologies and products. This plenary session will focus on those competing tensions and the opportunities to promote a regulatory environment that simultaneously encourages innovative behaviors, provides safeguards against unforeseen consequences, and leads to peak pharmaceutical innovation and quality assurance.

    10:30 a.m. | Facilitating the Development of Advanced Therapies
    Peter W. Marks, MD, PhD,
    Director, CBER, U.S. FDA

    11:00 a.m. | Industry Trends in Innovation Drive the Need for Integrated Quality
    Greg C. Guyer, PhD, MBA, Senior Vice President, Operations, Bristol-Myers Squibb

    11:30 a.m. | Q&A Panel with Additional Panelist
    Ilisa B. Bernstein, PharmD, JD, Deputy Director, CDER, U.S. FDA

    12:00 p.m. | Closing Remarks from Conference Co-Chairs

Networking Opportunities

Monday Evening Reception

7:00 p.m. - 10:00 p.m.

Unwind from a busy first day during the Monday Evening Reception! Use this time to catch up or make new connections with colleagues, peers, and suppliers over food and drinks. All attendees are permitted to attend. Guest tickets can be purchased for $60. 

Highlighted Speakers

Patrizia  Cavazzoni
Patrizia Cavazzoni
David M. Churchward
David M. Churchward
Jackie Elbonne
Jackie Elbonne
Bristol-Myers Squibb
Rick L. Friedman
Rick L. Friedman
Martine L. Hartogensis
Martine L. Hartogensis
Peter W. Marks
Peter W. Marks
Marschall S. Runge
Marschall S. Runge
University of Michigan
Douglas R. Throckmorton
Douglas R. Throckmorton

Additional Information

  • Learning Objectives

    Learning Objectives

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

    • Improve data integrity
    • Assure product availability and avoid shortages
    • Establish robust processes and maintain a state of control
    • Scoping and initiating investigations for OOS/OOT findings
    • Successfully implement innovative products and manufacturing operations
    • Manage post-approval changes
    • Update facilities to support dependable quality and supply
  • Who Should Attend

    Who Should Attend

    Departments: Research and Development | Regulatory Affairs | Manufacturing | Quality | Assurance/Control | Marketing | Sales

    Job Function: Compliance/Inspection Management | Supply Chain | Auditing | Executive Management

    Academia: Pharmaceutical sciences | Regulatory science

Got a Question? We have answers

Contact Us


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: (202) 898-9000

Renaissance Washington, DC Downtown Hotel
  • Accommodations

    A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $317 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, August 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    Cut Off Date: The cut off date has now passed. Please contact the hotel directly to secure a room based on availability.

    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 prior to the date of arrival by 6:00 p.m. (EST) to avoid cancellation fees.

  • Amenities

    The Renaissance Washington, DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded luxurious bedding, coffee makers, hair dryers, iron, and an ironing board.

How to Get Here

By Air

Area Airports

Ronald Reagan Washington National Airport (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Washington Dulles International Airport (IAD) is 28 miles away and Baltimore/Washington International Thurgood Marshall Airport (BWI) is 32 miles away.

Ground Transportation

Taxi fares from DCA are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from IAD is approximately $75 and from BWI is about $75.

By Car

Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking

$35 / Daily Self-Parking
$45 / Daily Valet Parking

Other Options


Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.


Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit


Registration Fees

Early Registration
Registration Type Price by July 30
Conference Conference + Workshop
Workshop is independently sponsored by PDA
Member $2,395 $3,740
Non-member $2,674 $4,219
Young Professional Member $1,198 $1,946
Gov’t/Health Auth. Member $700 $1,400
Gov’t/Health Auth. Non-member* $700 $1,500
Academic Member $700 $1,400
Academic Non-member* $800 $1,600
Student Member $280 $560
Student Non-member* $310 $620

Regular Registration
Registration Type Price after July 30
Conference Conference + Workshop
Workshop is independently sponsored by PDA
Member $2,995 $4,640
Non-member $3,274 $5,119
Young Professional Member $1,489 $2,337
Gov’t/Health Auth. Member $700 $1,400
Gov’t/Health Auth. Non-member* $700 $1,500
Academic Member $700 $1,400
Academic Non-member* $800 $1,600
Student Member $280 $560
Student Non-member* $310 $620
One Day Only Registration
Monday/Tuesday Only
Member $1,398
Non-member $1,510

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Aug 17, 2019, no fee will be charged. After Aug 17, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Aug 17, 2019, a full refund will be given minus a $200 fee. After Aug 17, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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