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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

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Program Highlights
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Overview

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.

Agenda

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

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

  • Monday, September 16

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

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

    8:00 a.m. – 10:00 a.m.
    P1: Opening Plenary: Manufacturing Innovation and Achieving the 20/20 Vision
    Moderator: David Jaworski, Senior Policy Advisor, CDER, FDA

    At this conference in 2009, 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 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.

    FDA and industry will discuss several key initiatives to advance innovation; the quality of biologics, devices, and drugs; competition; and promote public health. FDA leadership will discuss implementation of the 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.

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

    10:45 a.m.-12:15 p.m.
    P2: Learning from Failures to Implement Sustainable CAPAs 
    Moderator: Rick L. Friedman, MS, Deputy Director for Science and Regulatory Policy, OMQ, CDER, 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. – 11:15 a.m.
    Ronan Farrell, Head of Quality and Compliance, F. Hoffman-La Roche AG (INVITED)

    11:15 a.m. – 11:45 a.m.
    Jackie Elbonne, SVP Global Quality and Chief Quality Officer, Bristol-Myers Squibb (INVITED)

    11:45 a.m. – 12:15 p.m.
    Q&A Panel

    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.

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

    INNOVATION AND TECHNOLOGY

    A1: Quality Considerations for Connected Care and Devices
    Moderator: Valerie Whelan, Vice President R&D, Head of Quality, Compliance, Audit and L&P, 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. – 2:15 p.m.
    Industry Perspective on Quality Considerations for Connected Care and Devices 
    Industry Representative Invited

    2:15 p.m. – 2:45 p.m.
    Regulatory Perspective on Quality Considerations for Connected Care and Devices 
    Regulatory Representative Invited

    2:45 p.m. – 3:15 p.m.
    Q&A Panel

    QUALITY AND COMPLIANCE

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

    It’s back by popular demand! This session will include short 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. – 2:15 p.m.
    Regulatory Perspective on Current Compliance Issues and Case Studies
    Francis Godwin, Office Director (Acting), Office of Manufacturing Quality, CDER, FDA (INVITED)

    2:15 p.m. – 2:45 p.m.
    Regulatory Perspective on Current Compliance Issues and Case Studies
    Maria C. Anderson, Branch Chief, Biological Drug and Device Compliance Branch, CBER, FDA

    2:45 p.m. – 3:15 p.m.
    Q&A Panel

    LIFECYCLE IMPLEMENTATION

    C1: Quality by Design Lessons Learned and Where We are Now
    Moderator: Bita Mirzai-Azarm, Branch Chief, Division of Liquid Drug Products, CDER, 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 FDA and further improve collaboration by providing regulatory feedback and industry’s experience on commonly observed deficiencies.

    1:45 p.m. – 2:15 p.m.
    Industry Perspective on Quality by Design Lessons Learned and Where We are Now
    Kiran Krishnan, PhD, Senior Vice President, Global Regulatory Affairs, Apotex Corporation (INVITED)

    2:15 p.m. – 2:45 p.m.
    Regulatory Perspective on Quality by Design Lessons Learned and Where We are Now
    Reynold Tan, PhD, Quality Assessment Lead, OPQ, OLDP, Division of Liquid Based Products, CDER, FDA (INVITED)

    2:45 p.m. – 3:15 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

    INNOVATION AND TECHNOLOGY

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

    New technologies, like augmented reality and artificial intelligence, continue to drive innovation in the pharmaceutical industry. The ability to innovate will be critical to a company’s success in the future. Companies will have to embrace these scientific and technological advances to stay competitive and meet customer expectations. This session will explore current and proposed application of augmented reality and artificial intelligence in the pharmaceutical industry. Hear industry experts discuss the benefits and challenges of implementing these technologies while the FDA speaks to the current regulatory complexities.

    4:00 p.m. – 4:20 p.m.
    Industry Perspective on Augmented Reality and Artificial Intelligence
    Industry Representative Invited

    4:20 p.m. – 4:40 p.m.
    Artificial Intelligence in a Manufacturing Environment
    Robert Bowden, PhD, Senior Director CAR-T Advance Therapies, Johnson and Johnson (INVITED)

    4:40 p.m. – 5:00 p.m.
    Conceptualization through Implementation
    Regulatory Representative Invited

    5:00 p.m. – 5:30 p.m.
    Q&A Panel

    QUALITY AND COMPLIANCE

    B2: Quality Systems: Focus on Change Management Program
    Moderator: Rebecca Devine, PhD, Regulatory 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.

    4:00 p.m. – 4:30 p.m.
    Industry Perspective on Quality Systems
    Kimberly Bruhin, Director, Quality Systems, Janssen Inc. (INVITED)

    4:30 p.m. – 5:00 p.m.
    Q12 Update
    Ileana Barreto-Pettit, RN, MPH, Captain, U.S. Public Health Service, Drug National Expert, ORA, FDA (INVITED)

    5:00 p.m. – 5:30 p.m.
    Panel Discussion with Presenters and Additional Participant
    Chikako Torigoe, Biologist, CBER, FDA (INVITED)

    LIFECYCLE IMPLEMENTATION

    C2: Applying Phase Appropriate GMP: How to Approach Application of GMP for Expedited Programs 
    Moderator: Nicole K. Trudel, QA Team Leader, CBER, 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. – 4:30 p.m.
    Regulatory Perspective on Applying Phase Appropriate GMP
    CDR Qiao Y. Bobo, PhD, RAC, Branch Chief, CBER, FDA (INVITED)

    4:30 p.m. – 5:00 p.m.
    Indsutry Perspective on Applying Phase Appropriate GMP
    Keith Wonnacott, Executive Director, Regulatory Affairs, Pfizer (INVITED)

    5:00 p.m. – 5:30 p.m.
    Q&A Panel

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

    7:00 p.m. – 10:00 p.m.
    Grand Opening 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 Haigh Hutchens, PhD, Director, Global Chemistry Manufacturing Control Advisory Office, Worldwide Safety and Regulatory, Pfizer Biotech

    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. – 7:35 a.m.
    Regulatory Perspective on Rapid Microbiology
    Erika A. Pfeiler, Supervisory Microbiologist, CDER, FDA (INVITED)

    7:35 a.m. – 7:55 a.m.
    Industry Perspective on Rapid Microbiology
    Industry Representative Invited

    7:55 a.m. – 8:15 a.m.
    Q&A Panel

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

    Optimizing small and medium lot clean room practices - the products made by any pharmaceutical or biopharmaceutical manufacturer may be subject to 'manipulation' by a 503A Compounding Pharmacy, 503B Compounding Pharmacy, or any of hundreds of hospital pharmacies 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. What can you do to support these organizations to reduce risk to your product? Risk of loss of sterility, particles or precipitation, adverse events, loss of efficacy and more that could reflect adversely on your product? 

    Possible solutions would be providing the product in bulk containers, providing better information on compatibility and stability (i.e., does it need to remain at a pH above 8? Will it precipitate in the presence of calcium?) Indicating that the active will preferentially migrate into the rubber container closure (like fentanyl citrate) Or even setting up or purchasing a “captive”.

    7:15 a.m. – 7:45 a.m.
    Industry Perspective on Optimizing Small and Medium Lot Cleanroom Practices
    Christopher J. Smalley, PhD, Compounding Pharmacist Advisor, ValSource, LLC (INVITED)

    7:45 a.m. – 8:15 a.m.
    Panel Discussion with Presenters and Additional Participant
    Ian F. Deveau, PhD, Supervisory Consumer Safety Officer, CDER, FDA (INVITED)

    Breakfast 3: Regulatory Reporting
    Moderator: Paul Perdue, Jr., Branch Chief, Pharmaceutical Quality Program Operations Branch, ORA, 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. – 7:35 a.m.
    Field Alert Reports
    Elise A. Murphy, Supervisory Consumer Safety, CDER, FDA (INVITED)

    7:35 a.m. – 7:55 a.m.
    Biological Product Deviation Reports
    Kimberly M. Rains, Regulatory Officer, CDER, FDA (INVITED)

    7:55 a.m. – 8:15 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 US 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. – 7:45 a.m.
    Regulatory Perspective on Quality Systems
    Regulatory Representative Invited

    7:45 a.m. – 8:15 a.m.
    Q&A Panel

    Breakfast 5: Data Integrity
    Moderator: Susan Schniepp, 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. – 7:45 a.m.
    Industry Perspective on Data Integrity
    Industry Representative Invited

    7:45 a.m. – 8:15 a.m.
    Panel Discussion with Presenters and Additional Participants

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

    Featuring Compliance Directors from the 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 FDA has found during inspections, significant regulatory actions initiated, and FDA’s current enforcement strategy for a wide array of regulated products. In a Roundtable format, 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 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 FDA’s top leadership.

    Panelists
    Michael Levy, Deputy Director for Policy and Analysis, Office of Compliance, CDER, FDA (INVITED)
    William H. Maisel, MD, MPH, Director, Office of Product Evaluation and Quality, CDRH, FDA (INVITED)
    Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality, CBER, FDA
    CVM, FDA Representative Invited
    ORA, FDA Representative Invited

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

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

    INNOVATION AND TECHNOLOGY

    A3: Innovations in Aseptic Processing
    Moderators: Shane Killian, MS, 
    Senior Director, Licensing & Acquisition Head, Johnson & Johnson and Lynnsey A. Renn, PhD, Public Health Analyst, Office of Manufacturing Quality, CDER, 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. – 11:15 a.m.
    Industry Perspective on Innovations in Aseptic Processing
    Chakradhar Padala, Director, Drug Product Pilot Ops & Next Gen Technologies, Process Development, Amgen (INVITED)

    11:15 a.m. – 11:45 a.m.
    Regulatory Perspective on Innovations in Aseptic Processing
    Bryan S. Riley, Supervisory Microbiologist, CDER, FDA (INVITED)

    11:45 a.m. – 12:15 p.m.
    Q&A Panel

    QUALITY AND COMPLIANCE

    B3: Facility Lifecycle
    Moderator: David Doleski,
     Compliance Head for Biologics Quality Operations, Sanofi

    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 the quality unit. This can reveal and assess the suitability of the plant and highlights areas needing mitigation and drives pro-active improvement. This session will share an example approach that is used within a company. 

    10:45 a.m. – 11:15 a.m.
    Regulatory Perspective on Facility Lifecycle
    Rick L. Friedman, MS, 
    Deputy Director for Science and Regulatory Policy, OMQ, CDER, FDA

    11:15 a.m. – 11:45 a.m.
    Facility and Equipment Assessment to Ensure Microbial Control throughout the Lifecycle
    Cheryl Essex, MS, 
    Head of Microbiological Control for Biologics, Sanofi (INVITED)

    11:45 a.m. – 12:15 p.m.
    Panel Discussion with Speakers and Additional Panelists
    Hal S. Baseman, Chief Operations Officer, ValSource, LLC (INVITED)

    INSPECTION AND AUDITS

    C3: The New Inspection Paradigm
    Moderator: Mai X. Huynh, MS,
     Supervisory Team Leader, CVM, FDA

    How can drug inspection be improved? Based on feedback received throughout the last few years, the 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 FDA's current thinking how a facility can best develop an effective response to FDA Form 483 Inspectional Observations. 

    10:45 a.m. – 11:05 a.m.
    Current Activities with the FDA/EU Mutual Recognition Agreement
    David Churchward, 
    Expert GMP Inspector, Medicines & Healthcare products Regulatory Agency

    11:05 a.m. – 11:25 a.m.
    Pilot Program: The New Inspection Protocols Project (NIPP)
    Rosa J. Motta, 
    Supervisory Consumer Safety, CDER, FDA (INVITED)

    11:25 a.m. – 11:45 a.m.
    Responding to FDA Form 483 
    David Jaworski,
     Senior Policy Advisor, CDER, FDA

    11:45 a.m. – 12:15 p.m.
    Panel Discussion with Speakers and Additional Participants

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

    Back by popular demand and at a new time! Grab your boxed lunch and bring questions for 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

    Panelists
    Derek S. Smith, Supervisory Chemist, CDER, FDA (INVITED)

    Inspection-Based Panel Discussion

    Panelists
    Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA (CONFIRMED)
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, FDA (INVITED)

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

    INNOVATION AND TECHNOLOGY

    A4: Continuous Manufacturing Update
    Moderator: Clarice Haigh Hutchens, PhD, Director, Global Chemistry Manufacturing Control Advisory Office, Worldwide Safety and Regulatory, Pfizer Biotech

    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. 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 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. – 2:05 p.m.
    Industry Update on Continuous Manufacturing
    Industry Representative Invited

    2:05 p.m. – 2:25 p.m.
    Regulatory Update on Continuous Manufacturing
    Sau L. Lee, Director, Office of Testing, CDER, FDA (INVITED)

    2:25 p.m. – 2:45 p.m.
    Continuous Manufacturing Case Study
    Industry Representative Invited

    2:45 p.m. – 3:15 p.m.
    Q&A Panel

     
     

    QUALITY AND COMPLIANCE

    B4: Investigations: Quality Risk Management and Structured Investigational Approaches 
    Moderator: Rebecca E. Dombrowski, Process and Facility Reviewer, Division of Inspectional Assessment, CDER, 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. – 2:05 p.m.
    Industry Perspective on Quality Risk Management and Structured Investigational Approaches 
    Tia Bush, Senior Vice President, Quality, Amgen (INVITED)

    2:05 p.m. – 2:25 p.m.
    Industry Perspective on Quality Risk Management and Structured Investigational Approaches
    Kevin M. Jenkins, Vice President, Quality for Sterile Injectables,Pfizer (INVITED)

    2:25 p.m. – 2:45 p.m.
    Regulatory Perspective on Quality Risk Management and Structured Investigational Approaches
    CDR Binh T. Nguyen, PharmD, Consumer Safety Officer, CDER, FDA (INVITED)

    2:45 p.m. – 3:15 p.m.
    Q&A Panel

    INSPECTION AND AUDITS

    C4: How Effective Is Your Audit Program?
    Moderators: Susan Schniepp, 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. – 2:15 p.m.
    Large Pharma Company Perspective
    Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.(INVITED)

    2:15 p.m. – 2:45 p.m.
    Small/Start Up Company Perspective
    Guy Villax, CEO, Hovione (INVITED)

    2:45 p.m. – 3:15 p.m.
    Panel Discussion with Speakers and Additional Participant
    David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

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

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

    INNOVATION AND TECHNOLOGY

    A5: Cell and Gene Therapy: CMC Considerations
    Moderator: Carol L. Rehkopf, Chief, Review Management Business Operations Staff, CBER, 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 FDA approval and launch to market. A case study will be provided that outlines one company's journey in this space.

    4:00 p.m. – 4:30 p.m.
    Regulatory Perspective on Cell and Gene Therapy: CMC Considerations
    Kimberly Schultz, Product/CMC Reviewer, CBER, FDA (INVITED)

    4:30 p.m. – 5:00 p.m.
    Industry Perspective on Cell and Gene Therapy: CMC Considerations
    Industry Representative Invited

    5:00 p.m. – 5:30 p.m.
    Q&A Panel

    QUALITY AND COMPLIANCE

    B5: OOS and Effective Remediation: Chemical and Microbiological
    Moderator: Renée Kyro, MBA, Director, Shared Services, Quality Assurance, 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 FDA's perspective on current laboratory OOS inspection observations.

    4:00 p.m. – 4:30 p.m.
    Inspection Observations
    Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA

    4:30 p.m. – 5:00 p.m.
    Investigation Case Studies
    Sean McEwan, Vice President, Quality Assurance, Abbvie Operations, Abbvie (INVITED)

    5:00 p.m. – 5:30 p.m.
    Panel Discussion with Speakers and Additional Participant

    INSPECTION AND AUDITS

    C5: The Value of Selecting the Right Consultant
    Moderators: Rebecca Devine, PhD, Regulatory Consultant and Susan Schniepp, 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. – 4:30 p.m.
    Regulatory Perspective on the Value of Selecting the Right Consultant
    Regulatory Representative Invited

    4:30 p.m. – 5:00 p.m.
    Industry Perspective on the Value of Selecting the Right Consultant
    Industry Representative Invited

    5:00 p.m. – 5:30 p.m.
    Panel Discussion with Speakers and Additional Participants

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

     

  • 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
    Moderator: Jacqueline Kunzler, PhD,
    Chief Quality Officer, Baxter International

    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. – 7:35 a.m.
    Overview of Statistical Process Control
    Karthik B. Iyer,
    Supervisory Consumer Safety, CDER, FDA (INVITED)

    7:35 a.m. – 7:55 a.m.
    Industry Case Study using Statistical Process Control
    Jayme Patterson,
    Operations Excellence Manager, Baxter Healthcare Corp. (INVITED)

    7:55 a.m. – 8:15 a.m.
    Q&A Panel

    Breakfast 7: Using Emerging Tools to Understand Post-Market Patients'/Consumers' Perspectives on Quality
    Moderator: Neil A. Stiber, PhD,
    Associate Director for Science and Communication (Acting), Office of Surveillance, CDER, 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. – 7:35 a.m.
    Regulatory Perspective on Using Emerging Tools to Understand Post-Market Patients'/Consumers' Perspectives on Quality
    Christine S. Lee,
    General Health Scientist, CDER, FDA (INVITED)

    7:35 a.m. – 7:55 a.m.
    Academic Perspective on Using Emerging Tools to Understand Post-Market Patients'/Consumers' Perspectives on Quality
    Hyunwoo Park, Assistant Professor, Department of Management Sciences, The Ohio State University (INVITED)

    7:55 a.m. – 8:15 a.m.
    Q&A Panel

    Breakfast 8: Quality Culture
    Moderator: Susan Schniepp, 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. – 7:45 a.m.
    Quality Culture Role Play

    Cylia Chen, Member, PDA Quality Metrics Task Force (INVITED)
    Steve Mendivil, Member, PDA Quality Metrics Task Force (INVITED)

    7:45 a.m. – 8:15 a.m.
    Q&A Panel

    Breakfast 9: Aseptic Processing for Cell and Gene Therapy Products
    Moderator: Laurie P. Norwood
    , Consultant

    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 FDAs 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. – 7:45 a.m.
    Regulatory Perspective on Aseptic Processing for Cell and Gene Therapy Products
    Lily Y. Koo, PhD,
    Consumer Safety Officer CBER, FDA (INVITED)

    7:45 a.m. – 8:15 a.m.
    Q&A Panel

    Breakfast 10: Smoke Studies
    Moderator: Lynnsey A. Renn, PhD,
    Public Health Analyst, Office of Manufacturing Quality, CDER, 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. – 7:45 a.m.
    Industry Perspective on Smoke Studies
    Industry Representative Invited

    7:45 a.m. – 8:15 a.m.
    Q&A Panel

    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 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 FDA senior management officials from various FDA Centers in this highly interactive session! In a round table 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.

    Panel Discussion
    Peter W. Marks, MD, PhD, Director, CBER, FDA
    Steven Solomon, DVM, Director, CVM, FDA
    Douglas Throckmorton, MD, Deputy Center Director for Regulatory Programs, CDER, FDA

    10:30 a.m. – 12:15 p.m.
    P5: The Evolving Regulatory Landscape
    Moderator: John 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 flexibility are critical to promote meaningful advancements. Likewise, clear compliance standards are equally important to ameliorate risk related to the uncertainty inherent in the application of innovative technologies. 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.

    10:30 a.m. – 11:00 a.m.
    Regulatory Perspective on the Evolving Regulatory Landscape
    Peter W. Marks, MD, PhD, Director, CBER, FDA

    11:00 a.m. – 11:30 a.m.
    Industry Perspective on the Evolving Regulatory Landscape
    Industry Representative Invited

    11:30 a.m. – 12:00 p.m.
    Q&A Panel

    12:00 p.m. – 12:15 p.m.
    Closing Remarks and Introduction of 2020 PDA/FDA Joint Regulatory 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.

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

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

Got a Question? We have answers

Contact Us

Travel

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

Make a Reservation
Renaissance Washington, DC Downtown Hotel
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    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.

    To make reservations, individuals may click on the reservation link above or call the Renaissance Washington, DC Downtown Hotel at +1 (202) 898-9000. Please make sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

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

Ground Transportation

Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles 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

Metro

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

Train

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

Directions

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.

Sponsors

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Featured Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

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Media Partners

Contact

Program Inquiries
  • Molly O’Neill Moir, CMP
    Vice President
    Tel: +1 (301) 656-5900 ext. 132
  • Jason E. Brown
    Assistant Director, Programs
    Tel: +1 (301) 656-5900 ext. 131
Exhibition Inquiries
Training Course Inquiries
  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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