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Full Schedule

Full Schedule

  • Monday, September 27, 2021
  • 09:15 – 11:00 EDT
    Plenary 1: Opening Plenary

    Moderator: Francis RW Godwin, MBA – U.S. FDA

  • 11:00 – 11:30 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 11:00 – 12:00 EDT
    Poster Presentations
  • 11:30 – 13:00 EDT
    Plenary 2: Emerging Stronger through Collaboration

    Moderator: Valerie Whelan – Thermo Fisher Scientific

    A wise man said that “Perseverance is not a long race; it is many short races one after the other.”

    Over the last eighteen months, we have won many of these short races together as we have adapted to the changing landscape driven by the pandemic. In this session we will hear from regulatory and industry leaders on those races; the practical challenges we have overcome from the simple to the complex, the transformative level of collaboration we have seen internally and externally, the innovation that we have accelerated and the changes that will enable us to emerge stronger.

  • 13:00 – 13:30 EDT
    Press Conference
  • 13:00 – 13:30 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 13:30 – 15:00 EDT
    A1: Managing Investigations in a Global Network

    Moderator: Rick L. Friedman, MS – U.S. FDA

    Today’s global pharmaceutical supply chain typically includes many contributors to production of a drug. Strong quality system provisions and actions are needed when deviations, OOS results, or failures occur to ensure communications and close collaboration on investigations and resolutions. This session will address the attributes of quality systems that successfully manage cross-organizational investigations, with an emphasis on lessons learned and practical case studies.

    QUALITY ASSURANCE & QMS

  • 13:30 – 15:00 EDT
    B1: Supply Chain Collaboration and Product Approvals during a Pandemic

    Moderator: Paul Z. Balcer – U.S. FDA

    As treatments for COVID-19 infections were deployed during the pandemic, we were faced with challenges in drug supply of life saving medicines. Some countries enacted export bans of certain drugs, and other factors including plant staffing caused strains on the existing supply chains of APIs, raw materials, and finished drug products. Pandemic travel bans limited inspections of drug manufacturing facilities. We will examine the effect of the pandemic on drug supply chain and drug applications. The session will include regulatory experiences with EUAs and how use of tools such as remote assessments provided insight into facilities named in drug applications.

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

  • 13:30 – 15:00 EDT
    C1: Holistic Capacity Planning: Best Practices and Lessons Learned from New Therapeutic Modalities

    Moderator: Ingrid Markovic, PhD – U.S. FDA

    Sudden onset of market and public health demands during in the face of global pandemic could lead to major capacity crunches causing production delays and/or unintended product quality outcomes. Holistic evaluation of process, facility, and operational requirements to identify potential bottlenecks is critical when planning for projected commercial manufacturing expansion (scale-up or scale-out) to ensure timely delivery of transformative therapies to patients with consistent product quality. Rapid advancement of C>s products and COVID-19 vaccines necessitated implementation of flexible and sustainable operational and facility designs. These could offer valuable learnings with operational aspects of individualized therapies possibly as challenging as those for the off-the-shelf products.

    EMERGING TRENDS & INNOVATION

  • 15:00 – 15:30 EDT
    Connect & Network
  • 15:00 – 15:30 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 15:30 – 17:00 EDT
    Ask the Regulators: Inspection-Based
    U.S. FDA investigators, reviewers, and compliance officers will answer your questions in this Q&A session that will provide you with insights regarding current topics and initiatives.
  • 15:30 – 17:00 EDT
    Ask the Regulators: Review-Based
    U.S. FDA investigators, reviewers, and compliance officers will answer your questions in this Q&A session that will provide you with insights regarding current topics and initiatives.
  • 17:05 – 17:30 EDT
    Faramarz test session

    Presenter: Faramarz Kolivand, PhD – PDA Web Developerrrrrrrrrrrr

  • Tuesday, September 28, 2021
  • 08:30 – 09:30 EDT
    Special Topic 1: Deep Cold Storage

    Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.

    Studies have shown that ultra-cold temperatures (-70° C and colder) can introduce risk to the container closure integrity (CCI) of a sealed sterile product vial. This session will present and describe a robust approach for mitigating this risk using work done for the BNT162 mRNA vaccine as a case study. The work included the application of QbD principles to generate robust analytical data on the primary packaging system in the development phase, and then using this data for risk-based qualification and control of the vial sealing process. The holistic approach described and discussed in this session is useful for upcoming therapies needing an ultra-cold chain for storage and distribution.
  • 08:30 – 09:30 EDT
    Special Topic 2: Quality Management Maturity (QMM) and Metrics: What Does the Future Hold?

    Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer

    Hear latest update from CDER/OPQ on their QMM and Metrics programs. PDA’s Quality Management Maturity Task Force has built upon prior PDA research to assess the top QMM elements for FDA consideration in their QMM program. PDA’s Quality Culture Assessment Tool standards team will share a sneak peek of the public draft of the standard being released for peer review this fall. This session will begin with a brief update on PDA’s QMM initiatives with their recommendations on which QMM elements are important for FDA to consider in developing an assessment model. FDA OPQ will present a brief status of the QMM Pilot and their future metrics and QMM plans. A prepared interview with FDA and industry panelists will follow with time for audience Q&A at the end.
  • 08:30 – 09:30 EDT
    Special Topic 3: Current Microbiology Topics

    Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.

  • 09:30 – 09:45 EDT
    Break
  • 09:45 – 11:15 EDT
    Plenary 3: Compliance Office Updates

    Moderator: John D. Ayres, MD – Pharma Safety Solutions, LLC

    Featuring Office of Compliance leaders from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. In a virtual Roundtable format, U.S. FDA’s top leaders in Compliance and Enforcement will describe their programs, initiatives, and recent actions related to inspection and compliance. Current regulatory challenges and FDA’s current enforcement strategy for a wide array of medical products will be addressed. This is the best possible opportunity for you to understand U.S. FDA’s thinking and expectations for industry compliance. Most importantly, there will be ample time for the audience to ask questions of U.S. FDA’s senior leadership.
  • 11:00 – 12:00 EDT
    Poster Presentations
  • 11:15 – 11:45 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 11:45 – 13:15 EDT
    Plenary 4: Current GMP Compliance Trends and Topics

    Moderator: David L. Chesney, MSJ – DL Chesney Consulting, LLC

    New this year as a plenary, this perennial “standing room only” session will include presentations from CDER and CBER CGMP managers that are designed to provide insights beyond the usual “Top 10” 483 observations. Attendees will learn about major CGMP issues and notable warning letters. These presentations will be followed by a discussion with Center and ORA panelists.
  • 13:15 – 13:30 EDT
    Break
  • 13:30 – 15:00 EDT
    A2: Non-Sterile Drug Products: Microbial Risks

    Moderator: Pahala Simamora, PhD – U.S. FDA

    QUALITY ASSURANCE & QMS

  • 13:30 – 15:00 EDT
    B2: Supplier Oversight

    Moderator: Keduo Qian, PhD – U.S. FDA

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

  • 13:30 – 15:00 EDT
    C2: Drug Quality Lifecycle: Current Regulatory Concerns

    Moderator: Patricia F. Hughes, PhD – U.S. FDA

    EMERGING TRENDS & INNOVATION

  • 15:00 – 15:30 EDT
    Connect & Network
  • 15:00 – 15:30 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 15:30 – 17:00 EDT
    A3: Quality Systems: How to Ensure Resilience and Effectiveness

    Moderator: Denise M. DiGiulio (she/her/hers) – Genentech

    Quality is a mindset that impacts everyone and every relevant decision we make. A quality mindset starts at the top with strong support from executive leadership and is embedded in all functions and actions. A modern quality system and risk management approaches help manufacturers to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations for drugs (2l CFR parts 210 and 211) on a continuous basis.

    This session will explain why regulatory actions are taken and how regulators determine regulatory significance. An experienced quality professional will share her knowledge and experience in the remediation of several Consent Decrees and warning letters. The road to remediation has required systemic improvements in quality culture and quality systems. Insights into establishing and sustaining a culture of quality assurance (and thus CGMP compliance) will be explained by senior leadership from both the regulatory and industry perspective.

    QUALITY ASSURANCE & QMS

  • 15:30 – 17:00 EDT
    B3: Manufacturing during and after the Pandemic

    Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

  • 15:30 – 17:00 EDT
    C3: Improving Manufacturing via Modern Technology

    Moderator: Rebecca E. Dombrowski, MS – U.S. FDA

    EMERGING TRENDS & INNOVATION

  • Wednesday, September 29, 2021
  • 08:30 – 09:30 EDT
    Special Topic 4: PDA QbD Book and PDA Vaccine Development Lifecycle Technical Report

    Moderator: Valerie Whelan – Amgen Inc.

  • 08:30 – 09:30 EDT
    Special Topic 5: AI Research Force (AIRForce) Group: Focus on Artificial Intelligence and Machine Learning

    Moderator: Rebecca E. Dombrowski, MS – U.S. FDA

  • 08:30 – 09:30 EDT
    Special Topic 6: Risk Management of Non-Ingredient Suppliers

    Moderator: Mai X. Huynh, MS – U.S. FDA

  • 09:30 – 09:45 EDT
    Break
  • 09:45 – 11:15 EDT
    Plenary 5: Center Updates

    Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.

    The global regulatory landscape is evolving, and innovative approaches to product life cycle and quality paradigms are met by new real-life challenges and complexities every day – patient-individualized medicines, supply challenges for legacy products, transition to new technologies, highly globalized supply chains. How will U.S. FDA continue to optimize its mission to safeguard the quality, safety, and effectiveness of medicines for patients even with these manufacturing and supply challenges? After introductory presentations, your questions on these and other issues will be posed to FDA executive management from various FDA Centers! In a virtual round table format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space.
  • 11:15 – 11:45 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 11:45 – 13:15 EDT
    A4: Process Validation Lifecycle: 10 Years in Review

    Moderator: CDR Tara Gooen Bizjak, MBS – U.S. FDA

    QUALITY ASSURANCE & QMS

  • 11:45 – 13:15 EDT
    B4: ICH’s Initiatives to Advance Global Harmonization, Innovation, and Continual Improvement Throughout Lifecycle

    Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

  • 11:45 – 13:15 EDT
    C4: Moving Quality to the Next Level: "What Would it Take?"

    Moderator: Mike G. Labruto, MS – University of Pennsylvania/Gene Therapy Program

    EMERGING TRENDS & INNOVATION

  • 13:15 – 13:45 EDT
    Connect & Network
  • 13:15 – 13:45 EDT
    Virtual Exhibit Hall
    To visit the Exhibitors, click on the Exhibit Hall tile on the home screen.
  • 13:45 – 15:15 EDT
    A5: Aging Facilities vs. Modern Facilities

    Moderator: Patricia F. Hughes, PhD – U.S. FDA

    QUALITY ASSURANCE & QMS

  • 13:45 – 15:15 EDT
    B5: Sterile Drug Hot Topics

    Moderator: Douglas A. Campbell – InterPro QRA

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

  • 13:45 – 15:15 EDT
    C5: All That Data…Now What?

    Moderator: Sharyl D. Hartsock – Eli Lilly and Company

    EMERGING TRENDS & INNOVATION

  • 15:15 – 15:45 EDT
    Break
  • 15:45 – 17:16 EDT
    Plenary 6: Thanks Science

    Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.

    We live in a time at which scientific discoveries – and technologies based on them – come at an unprecedented pace . . . and yet also at time when the public may be increasingly slow to trust scientists. How can we improve the way we – scientists, engineers, quality professionals -- communicate with the public about our work? This session will feature CBER Center Director Dr. Peter Marks and Baylor College of Medicine’s Dr. Peter Hotez, who will discuss with us their work in helping the public at large appreciate science and its contribution to public health. At the same time, we’ll take a moment to celebrate some of science’s successes and to appreciate not just how science impacts the world, but how world events impact science, spurring us to ever new innovations and discoveries.