Day 1
25 September 2019
  • 1300 - 1630
    Executive Forum: Assuring Due Diligence in Acquiring New Facilities - Separate Registration Required
    How do you assure due diligence when acquiring new facilities? This session will explore the importance of ensuring an effective due diligence process is undertaken to inform strategic acquisition decision-making. It will seek to examine the corporate role in establishing evidence that quality is integrated throughout the organization and that there is a good fit between the entities in terms of organizational/quality culture. The session will address:
    - "How to establish the maturity of the quality system and the level of integration of quality throughout the organization.
    - "How to gain an understanding of the various roles and responsibilities for assuring End-to-End product quality.
    - "Understanding the current influence of Global versus Local accountability - how are resources allocated?
    - "Current stakeholder communication approaches - how do they communicate issues up and down the chain from Board to workers?
    - "How do they identify, address and act to prevent drug shortages when quality issues are discovered? Where do the current decision-making processes related to drug shortages reside?
    - "What are the impacts on the acquisition decision regarding sites that are currently using new technologies?
    - "How are site selection decisions regarding new application or products made?
    Session Leaders
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Mylan NV
    Compliance Officer
    FDA/CDER
    Senior Consultant
    Commissioning Agents, Inc. (CAI)
    President & CEO
    Lachman Consultant Services, Inc
    Senior Director, Head Upjohn Global Engineering
    Pfizer Inc.
    Senior Principal Engineer
    AbbVie, Inc.
    Senior Associate
    Lachman Consultant Services
    President and CEO
    TGG, LLC (The Gintegra Group)
    Presentation Information
    [Business Integration Challenges and Solutions]
    Speaker: Rajiv Malik
    || [Key Points to Consider in Working with 3rd Party Partnerships]
    Speaker: Fran Zipp
Day 2
26 September 2019
  • 0845 - 1030
    Hear important updates on current trends in pharmaceutical quality and compliance. Gain insight from lessons learned through case studies, regulatory findings, and root cause investigations shared by global regulatory and industry experts. This session will set the stage for open dialog throughout the conference to help your organization prepare for emerging regulatory expectations for the pharma industry.
    Session Leaders
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Speakers
    Director, FDA India Office
    FDA
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Expert GMDP Inspector
    MHRA
    Senior Compliance Advisor
    Roche-Genentech
    Presentation Information
    [Update on Collaboration Efforts with India Regulators]
    Speaker: Letitia Robinson
    || [Welcome & Opening Remarks]
    Speaker: Carmelo Rosa
    || [Q10/Q12]
    Speaker: David Churchward
    || [Is Your CAPA System Effective? Proactive Approaches to Sustainable Quality and Compliance]
    Speaker: Michael Higgins

    Meeting and/or exceeding compliance requirements set forth by Health Authorities is an expectation and a prerequisite for product approvals and market access. When expectations are not met, it is important for companies to determine root cause in a systematic and holistic way and respond accordingly.
  • 1115 - 1230
    Quality & Compliance: Addressing Risk Mitigation
    Successful integration of newly acquired manufacturing sites presents unique challenges and requires a multifunctional approach. From due diligence activity through the integration of various commercial and operational functions, formal governance supported by strict project management and the coordination of various subject matter experts from many different departments is required. Careful consideration should be given to employ risk mitigation strategies to ensure compliance, quality and supply continuity are not impacted during the transition and integration periods. It is important not to assume that one size fits all when considering integration solutions specific to Information Technology, Knowledge Management, Business Processes, Commercial Strategies, etc. Firms need to take the time to understand and consider cultural differences and to establish a close collaboration with the new site leadership to facilitate a smooth transition through an effective change management approach. An effective integration process incorporates formal planning, dedicated leadership, established timelines, and a clear governance process to ensure effective execution and well-established communication channels for escalation of any critical issues. By using a comprehensive approach, firms can successfully complete the integration of newly acquired facilities in a manner that optimizes the value of the investment and avoids any unintended complications.
    Session Leaders
    Compliance Officer
    FDA/CDER
    Speakers
    Head of Global Quality Systems
    Mylan
    Site Quality Head
    Dr. Reddy's Lab
    Senior Associate
    Lachman Consultant Services
    Presentation Information
    [Techniques to Mitigate Risk Associated with Integrating Newly Acquired Manufacturing Sites ]
    Speaker: Derek Glover
    || [New way of monitoring and mitigating the product quality issues]
    Speaker: Narendira Kumar
    This presentation will cover the following topics:
    a) Product & process performance throughout product shelf life
    b) Product Quality monitoring
    c) Mitigating Product Quality issues by adopting various mechanism || [The Importance of Establishing A ‘Cultural’ Fit in The Integration Process]
    Speaker: Nuala Calnan
  • 1300 - 1500
    Modern approaches to validation using the latest technologies and risk-based methods available to the pharmaceutical industry remain under-utilized. This session will deep-dive into the opportunities to modernize approaches to validation and the current challenges in Commissioning and Qualifying facilities with case studies from recent new India facilities.
    Session Leaders
    Senior Principal Engineer
    AbbVie, Inc.
    Speakers
    Hyde Engineering + Consulting
    Compliance Officer
    FDA/CDER
    Senior Consultant
    Commissioning Agents, Inc. (CAI)
    Owner
    Biopharmaceutical Water Doc
    President and CEO
    Novatek International
    Presentation Information
    [The Conundrum entailing the Approach to Commission and Qualify Facilities ]
    Speaker: Ankur Verma
    There is a lot of debate around the industry for C&Q as to what shall be the approach, how best can the timeline and budget be optimised, Should we go the “V” way or the “Science and Risk Based” Way. This topic addresses the key concerns in C&Q for Greenfield facilities, how best to use Vendors and leveraging GEP into GMP. The presentation talks about the reasons for the Conundrum , the key aspects which one has to have in mind when following a certain path. It also talks about the Stakeholders alignment, pitfalls which block the progress of the C&Q project.
    || [Process Analytical Technology (PAT) versus Traditional Validation - How to adopt PAT to Ensure Sustainable Quality and Compliance with Higher Throughput]
    Speaker: Nissan Cohen
    Process Analytical Technology (PAT) was released to the pharmaceutical industry by the FDA in 2004, 15 years ago. Why hasn’t the industry adopted enmass this excellent technology in lieu of traditional validation and operations? Why has the industry been reticent to adopt one of the “Guidelines for the 21st Century” as outlined by the FDA? Find out how this technology has important implications to continuous manufacturing, continuous operations, sustainable quality, and compliance for 24/7 operations.
    || [URS & Implementation of Risk-Based Cleaning Validation Management System ]
    Speaker: Parsa Famili
    This presentation will discuss:

    -Manual Systems vs. Computerized Systems
    -Benefits of Compliant Computerized Cleaning Validation Software System
    -Components of a Compliant Cleaning Validation System
    -Cleaning Validation User Requirements Based on Inherent Risks
  • 1530 - 1700
    Unmasking the Reality of Out-of-Specifications (OOS) Investigations
    Why are regulatory inspectors still finding problems in Out-of-Specifications (OOS) investigations? Discussion of real examples will help you and your company to understand the difference between root cause analysis and CAPA. Learn how to establish a reliable and sustainable quality system.
    Session Leaders
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Compliance Officer
    FDA/CDER
    Placeholder Person Graphic
    Senior Vice President
    Biocon Ltd
    Presentation Information
    [Understanding the Materiality Concept in Out-of-Specifications Results Obtained from Pilot/Pre-Approval Batches (CR letters, PAI inspections that don’t make to the level of a warning letter, common problems in application review)]
    Speaker: Aditi Thakur
    || [Understanding Regulatory Expectations: A Deep Dive into the FDA Out-of-Specifications Guidance – (GMP/overall perspective, root cause, regulatory significance, examples of the good, the bad, the ugly)]
    Speaker: Frank Verni
    Testing is essential for a drug manufacturers successful operation. Not only is it required by the CGMP regulations, it is necessary to confirm that components, containers and closures, in-process materials, and finished products conform to specifications. Any Out-of-Specification (OOS) test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer shall be thoroughly investigated, whether or not the batch has already been distributed. This presentation will provide an overview of FDA’s Out-of-Specification Guidance, including case law that led to it’s development. Additionally, to demonstrate what regulators are seeing during inspections, the presentation will include multiple examples of Warning Letter violations and case studies.
    || [Meeting Regulatory Expectations]
    Speaker: Raman Srinivasan
Day 3
27 September 2019
  • 0830 - 0930
    Women in Pharma Breakfast Session
    Session Leaders
    President & CEO
    Lachman Consultant Services, Inc
    Senior Principal Engineer
    AbbVie, Inc.
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Bioprocess Systems Specialist, Merck Life Science
    Merck Life Science
    President & CEO
    Lachman Consultant Services, Inc
    President-Global Quality, Medical Affairs & Pharmacovigilance
    Cipla Ltd
    Presentation Information
    [Women in Pharma Panel Discussion]
    Speaker: Ranjani Pathak
  • 0930 - 1100
    Developments in Aseptic Processing
    What are the latest developments in aseptic manufacturing and what are the new regulatory expectations? Aseptic processing of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. There are a wide range of human and equipment factors to keeping the process sterile and compliant. We review recent findings both globally and regionally and how they impact current manufacturing and quality assumptions. With aseptic technology rapidly evolving with new process methods and innovations, how to remain cost effective and make the right decisions quickly? The use of disposable equipment and how it is finding its way into the whole production chain from de-bottlenecking operations to reducing contamination. What are the risks and opportunities? Understand how to integrate new technology and ensure appropriate alignment of quality processes. You will learn firsthand from industry leaders who understand these challenges and deal with them. Have a unique opportunity to discuss the challenges you're currently facing and gain some actionable ideas and solutions to improve your own processes.
    Session Leaders
    Senior Director, Head Upjohn Global Engineering
    Pfizer Inc.
    Speakers
    Director Operation Quality, QA Audit and Compliance
    AbbVie
    President and CEO
    TGG, LLC (The Gintegra Group)
    Presentation Information
    [Regulatory Expectations in Aseptic Processing: Review of Recent Findings]
    Speaker: Andrew Hopkins
    || [Single-Use Technologies: Advantages and Disadvantages]
    Speaker: Myriam Sosa
  • 1130 - 1315
    Data Integrity Across the Lifecycle: Past, Present, and Future
    Data Integrity Across the Lifecycle: Past, Present, & Future| Explore how the industry has changed over the past 5 years in its approach to data integrity - where we have been and what the future holds - from both regulatory and industry perspectives. A true and consistent retrospective look at early submissions reveals flaws that can inform current production and decision-making. Attendees will have the opportunity throughout the day to catalogue the data integrity challenges faced by their organizations for discussion during this round table session.
    Session Leaders
    Compliance Officer
    FDA/CDER
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Director, FDA India Office
    FDA
    Compliance Officer
    FDA/CDER
    Head of Global Quality Systems
    Mylan
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Expert GMDP Inspector
    MHRA
    Senior Associate
    Lachman Consultant Services
    Senior Compliance Advisor
    Roche-Genentech
    Presentation Information
    [Lifecycle Background/Application Perspective]
    Speaker: Aditi Thakur
    || [Their journey 2014 forward]
    Speaker: Derek Glover
    || [Knowledge Excellence: Good Data makes for Good Decision-Making]
    Speaker: Nuala Calnan
  • 1415 - 1515
    Understanding Quality: Where does GMP Begin?
    For several years, research scientists, quality and compliance professionals and regulators are faced with many discussions regarding a seemingly simple question, "Where does GMP start?" Scientists generally want to be able to experiment and may find the GMPs limit the scientific process. Some Regulators and Quality and Compliance professionals would like to have GMPs applied as early as possible. There are controls needed and challenges encountered in development, technical transfers and method and process optimization. This session will explore key aspects of this anything but simple question and implications of decisions as well as provide real-life examples and guidance for anyone struggling with this.
    Session Leaders
    President & CEO
    Lachman Consultant Services, Inc
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Placeholder Person Graphic
    General Manager
    Zydus Cadila
    Presentation Information
    [Where should the controls start? Or application review process – how a review is conducted, application submission and review process]
    Speaker: Aditi Thakur
    || [Understanding Quality: Where does GMP Begin?]
    Speaker: Rajesh Kumar Singh
    For several years, research scientists, quality and compliance professionals and regulators are faced with many discussions regarding a seemingly simple question, “Where does GMP start?” Scientists generally want to be able to experiment and may find the GMPs limit the scientific process. Some Regulators and Quality and Compliance professionals would like to have GMPs applied as early as possible. There are controls needed and challenges encountered in development, technical transfers and method and process optimization. This session will explore key aspects of this anything but simple question and implications of decisions as well as provide real-life examples and guidance for anyone struggling with this.
  • 1545 - 1700
    Remediation: Moving from Uncertainty to Robust Sustainability in CGMPs
    Once a 483, warning letter, import order, or non-compliance certificate is determined as the course of action, industry faces unique challenges to demonstrate that the operations are under control and that patients are not at risk. This session will be an opportunity to learn about the do's and don'ts during a remediation process. You will learn what regulators want to see during this phase and the process involved in re-inspecting the facility to demonstrate the appropriate corrective measures have been taken.
    Session Leaders
    President & CEO
    Lachman Consultant Services, Inc
    Speakers
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF
    Compliance Officer
    FDA/CDER
    President-Global Quality, Medical Affairs & Pharmacovigilance
    Cipla Ltd
    Director, Division of Drug Quality I
    FDA/CDER/OC/OMQ
    Expert GMDP Inspector
    MHRA
    Director Operation Quality, QA Audit and Compliance
    AbbVie
    Senior Associate
    Lachman Consultant Services
    Senior Compliance Advisor
    Roche-Genentech
    President and CEO
    TGG, LLC (The Gintegra Group)