Agenda

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Day 1
Thursday, 17 June 2021
  • 0300 - 0430
    Opening Plenary Session
    Quality Risk Management: Beyond Theory to Practical Implementation
    Many international regulatory authorities have published guidance/draft guidance on Quality Risk Management, as well as ICH and WHO. This fact highlights the importance of QRM in manufacturing and quality operations: it helps coordinate and direct an organization's activities to meet customer and regulatory requirements; it helps in day-to-day decision making within the quality and manufacturing units; it helps ensure the effectiveness of CAPAs; and it helps organizations improve effectiveness and efficiency on a continuous basis. However, despite the clear benefits and need for QRM, organizations often struggle with implementing one fully. In this session, we will discuss the practical implementation of a QRM and how to integrate and avail the organization to the resulting benefits in daily operations and sustainable supply.
    Session Leaders
    Speakers
    Presentation Information
    [Behind the Regulations: Understanding the Intent of Regulatory Guidelines ]
    Speaker: Kevin O'Donnell
  • 0500 - 0540
    Round 1- Case Study 1
    Practical Applications for Out-of-Specification (OOS) Investigations/Assessments Background to case-studies that will be addressed -   Issues observed included: observations of repeat testing until a better and/or passing result is obtained; Maximum number of retests NOT specified in SOP; vary based on variability of method and is adjusted during OOS Investigation; Multiple attempts of retesting and different definition of “retesting”; Disregarding OOS results and failure to thoroughly review unexplained discrepancies; Product quality failures are ignored without scientific justification. -Testing into Compliance -Averaging of failed replicates -Finding a flaw in the analysis after the run (e.g., Analyst failure/error/ SST/ QA oversight/ Decision making in QC) -Failure to extend investigation to other batches.
    Speakers
    Presentation Information
    [Practical Applications for Out-of-Specification Investigations/Assessments ]
    Facilitators: Georg Singewald and Aditi Thakur
  • 0500 - 0540
    ROUND 1- Case Study 2
    Cross Contamination Controls A lab assay discovers viral residue in a product that was recently released. This plan will include an emergency response describing market action, remediation and plans to effectively communicate with regulatory authorities and customers.
    Speakers
    Presentation Information
    [Cross Contamination Controls.]
    Facilitators: Tony Crincoli and Vivianne Arencibia
  • 0500 - 0540
    ROUND 1 - Case Study 3
    Critical Review of Quality and Manufacturing Data Emer-Pen is part of General-Pharma’s auto-injector portfolio. It is a single-use drug-device combination product, comprising device components with sterile injectable solution cartridge. Emer-Pen is used in life-threatening emergencies prior to gaining access to qualified medical care. Approximately 4 million packs (2 devices per pack) were prescribed in the local market during financial year 2015-16.
    Speakers
    Presentation Information
    [Critical Review of Quality and Manufacturing Data.]
    Facilitators: David Chruchward and Deva Puranam
  • 0500 - 0540
    ROUND 1 - Case Study 4
    Aseptic Processing Controls
    Speakers

    Brooke Higgins

    Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
    FDA/CDER/OC/OMQ
    Presentation Information
    [ Aseptic Processing Controls ]
    Speakers: José Meléndez and Brooke Higgins
  • 0550 - 0630
    ROUND 2 - Case Study 1
    Practical Applications for Out-of-Specification (OOS) Investigations/Assessments
  • 0550 - 0630
    ROUND 2 - Case Study 2
    Cross Contamination Controls
  • 0550 - 0630
    ROUND 2 - Case Study 3
    Critical Review of Quality and Manufacturing Data
  • 0550 - 0630
    ROUND 2 - Case Study 4
    Aseptic Processing Controls
  • 0645 - 0800
    Case Study Report-Outs and Discussion
    Session Leaders
    Speakers

    Brooke Higgins

    Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
    FDA/CDER/OC/OMQ
Day 2
Friday, 18 June 2021
  • 0300 - 0400
    Adapting During the Pandemic: Changing Regulatory Processes
    The COVID-19 pandemic forced unanticipated change in the way inspections, reviews and EUAs are handled by regulatory agencies and the industry. The impact on supply chain transfers, locations, registrations, and visibility is being felt across the industry.  This session will focus on the regulatory guidance and direction provided by global agencies for adapting to and managing remote processes and unprecedented supply chain needs.
    Session Leaders
    Speakers
  • 0415 - 0515
    Creating Comprehensive Responses To Regulatory Actions
    With an increasing number of non-conformances, warning letters/OAIs for sites governed by US regulations, one has to ask what the missing link might be. Companies responding to regulatory actions need to create comprehensive responses that not only address their remediation plan, but also identify how they intend to ensure the sustainability of the remediated processes. Surely, most companies participating this conference must have been through at least one USFDA physical audit. We are all fully aware that our expertise, presentation, knowledge, and behavior are important traits while facing agency investigators during inspection time. What is more important is our post-inspection behavior. How we read and understand a 483, how we respond, and how we communicate with the agency all play a vital role in how we will draw the closure lines. They can be good short ones or a very long one.  Response to a 483 observation is perhaps the last and best opportunity to tell your side of the story before many agency officials (compliance, enforcement, OMQ, OPQ, to name a few) who have not been to your facility and are unaware of what might have happened during the inspection. Form 483 is the living, guiding document for them to assess your facility and make some assumptions of what happened during inspection. You may be surprised to learn that FDA believes it is your responsibility to work with its investigators before they leave your facility to address any inaccuracies on the Form 483.  Fortunately, during these unprecedented times, the FDA has implemented an interim COVID-19 process for communicating with facilities following FDA review of records that will help companies to navigate the post-OAI requirements. Join us as we discuss how to create comprehensive responses to regulatory actions  with industry peers, SMEs, and global regulators (USFDA, MHRA).
    Session Leaders
    Speakers
    Presentation Information
    [Responding Effectively to Regulatory Inspectional Observations]
    Speaker: Narendira Kumar
    || [Legal Perspective on Effective Responses to Regulatory Inspections]
    Speaker: Scott Kaplan
  • 0515 - 0600
    CMO/CDMO Relationships, Management, and Quality
    As more organizations rely on CMO/CDMOs to meet supply demands, managing multiple sponsor requirements becomes challenging. As a sponsor, ensuring your requirements are met are critical. The track will specifically focus on the process of application and revision of such following significant compliance findings (eg Data Integrity) at the CMO/CDMO. What are some of the expectations if the applicant decides to withdraw the facilities (CMO) specifically under compliance action for the pending applications? What new data would be needed to support the application with the addition of a new site? We will discuss the challenges of a sponsor working with multiple CMOs during a pandemic and provide strategies to ensure adequate controls, oversight and consistency.
    Session Leaders
    Speakers
    Presentation Information
    [Understanding the Impact of CMO’s Compliance Action on the Submissions]
    Speaker: Aditi Thakur
    || [Lessons Learned from Managing Multiple CMOS to Concurrently Produce the Same Product ]
    Speaker: Vivianne Arencibia
  • 0615 - 0730
    Regulatory and Industry Panel
    Maintaining Full Transparency with Regulatory Agencies
    Session Leaders
    Speakers

    Joey Gouws, PhD

    Team Lead, Inspection Services, Prequalification Team
    World Health Organization

    Brooke Higgins

    Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
    FDA/CDER/OC/OMQ

    Jila Breeze

    EVP, Global Head Quality & Compliance
    SUN Pharmaceutical Industries, Inc.