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Full Schedule

Full Schedule

  • 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