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2022 Data Integrity

2022 PDA Data Integrity Workshop

Sep 15 - Sep 16, 2022
Washington, DC

Building a Data Culture: What it is and Why it Matters

  • Workshop
  • The Americas

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Program Highlights

The closing plenary will be a working lunch! You'll hear from U.S. FDA representatives and industry experts on how to bring key takeaways back to your leadership.


Technology, automation, and advanced usages of data are sweeping the global pharmaceutical industry, ushering in an era of innovation that is revolutionizing the way we monitor, diagnose, and treat patients all over the world. Equal to the hope and promise of innovative new medicines is the abiding benefit of mainstay treatments that have long enhanced people’s lives.

Realizing the healthcare mission to provide safe, effective, and quality drug products through GMP compliance is inextricable from data integrity, and thus data integrity remains at the forefront of concern to Health Authorities and manufacturers alike. Data governance is fast replacing earlier approaches to data integrity and is now the Regulatory expectation as a holistic way organizations can “build-in” data integrity compliance by design. Assuring data integrity compliance as an output of an intentional, risk-based scheme addressing people, processes, and technical controls, enables organizations to maintain compliance and meet quality attributes across an ever-growing ecosystem of data assets.

More and more, the influence of Quality Culture is at the forefront of the adoption of successful data governance. Regulatory guidance for data integrity suggests that a lack of leadership and Quality Culture can lead to a breakdown of quality systems and data integrity lapses. Thus, Health Authorities’ increased focus on the link between successful data governance and Quality Culture has become increasingly evident in enforcement actions such as Warning Letters. This “link” is further supported by leading research such as PDA’s Quality Culture Survey Report and St. Gallen’s “Impact of Quality Culture on Operational Performance”. Leadership responsibilities, organizational procedures, personnel behaviors, knowledge/risk and data management, and technical controls, must all be leveraged across data governance and Quality Culture strategies if data integrity compliance objectives are to be achieved.

This Workshop will be comprised of interactive case studies, presentations, and panel discussions addressing strategic and tactical elements of Data Governance with a focused lens on Quality Culture attributes. Speakers will share on a variety of topics including management responsibility, data governance programs, monitoring data integrity and cultural risk, “inspecting” culture, maturity models, enabling change, and advanced data usage. Come join us to share experiences, learnings, and ideas.


  • Day 1
  • Day 2

    07:00 – 17:30 | Registration

    07:00 – 08:30 | Continental Breakfast

    08:15 – 10:00 | P1: What is a ‘Data Culture’ and Why Does it Matter?
    Moderator: Doreen Newhouse, MSc, Principal, DN DI Consulting LLC

    So, “What is a Data Culture?” For starters, your organization already has one! In this session, we will define and explore “Data Culture” through the lens of data integrity compliance, discussing regulatory expectations for data governance and quality culture within the broader context of business excellence. Organizations that build a “Data Culture” through an integrated approach to robust data governance, quality systems, culture, and data analytics will benefit from compliance by-design and the ability to innovate towards the health and well-being of human beings from all over the world!

    08:15 | Welcome Remarks from Workshop Chair 
    Kir F. Henrici,
    CEO, The Henrici Group

    08:30 | Data Governance + Quality Culture: The Whole is Greater than the Sum of its Parts
    Kir F. Henrici, CEO, The Henrici Group

    09:00 | The Good News about U.S. FDA's Quality Management Metrics (QMM) and Data Integrity
    Peter E. Baker, MS, President, Live Oak Quality Assurance

    09:30 | Q&A

    10:00 – 10:30 | Refreshment Break

    10:30 –11:30 | Small Group Discussion 1: Maturity Model Exercise
    Moderator: Julie C. Maurhoff, Vice President, GxP Compliance, Ultragenyx

    Steven R. Mendivil, BS,
    Senior Advisor for Quality, Amgen Inc.
    Chuck Bornhoeft, Director, Quality Assurance, Rion

    This small group discussion will offer a high-level description of the Maturity Model tool developed by PDA. Measuring the maturity of key Quality Systems, such as Data Integrity Programs/Governance, can offer insight into a firm’s Quality Culture, and used as an input for developing relevant Quality Metrics. The group discussion will include a short activity to review and score a case study scenario using the PDA Maturity Model tool concepts and Q&A for our panel experts.

    11:30 –12:30 | Small Group Discussion 2: Metrics Best Practices to Drive Continuous Improvement
    Moderator: Meg Gallwitz, Principal Consultant, JAG Healthcare Consulting, LLC

    Richard N. Love, Director of Business Intelligence, L7 Informatics / Principal, HarborView LLC
    Hui-I K. Tom, Chemist, OPQ, CDER, U.S. FDA

    In this session, we will cover using metrics as a means to an end, and not as an end to themselves. The concept of big M metrics used as standard KPIs vs the use of little m metrics to drive continuous improvement will be introduced. This Workshop will give attendees hands-on experience in building global data management systems and automating the calculation and presentation of metrics with the ability to detect signals over noise by using process behavior charts. Then, we will explore the link between metrics data and quality culture.

    12:30 – 13:30 | Lunch

    13:30 – 14:45 | P2: Data Integrity Assessments: They don’t have to be Dry; Take Action in a Dynamic Environment!
    Moderator: Bethany B. Rexing, M&Q Data Management Director, Eli Lilly and Company

    Do you already have adequate controls in place to detect and mitigate data integrity vulnerabilities associated with you highest criticality data? Assessing the residual data integrity risks in your system, equipment, and/or process can be important. Many of us immediately think of conducting an assessment, writing a formal report, and working through the approval process when we hear the words “Data Integrity Assessment” which can be a very dry, and often tedious process, to create and maintain. It doesn’t have to be that way! These two presenters will share different methodology and/or case studies on how they performed data integrity assessments in a more dynamic way.

    13:30 | From Dry to Dynamic: Bringing Data to Life
    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    13:55 | Mindset and Behaviors: Critical Enablers to Data Integrity/Data Culture Excellence
    Doreen Newhouse, MSc, Principal, DN DI Consulting LLC

    14:20 | Q&A

    14:45 – 14:50 | Break into Concurrent Breakout Sessions

    14:50 – 15:45 | Breakout Sessions

    Breakout 1: Clinical Trial Data Integrity Control Strategy
    Moderator: Julie C. Maurhoff, Vice President, GxP Compliance, Ultragenyx

    Ndidi Rickert, Associate Director, Quality Culture Excellence, Ultragenyx
    Tara Safakish, BSc, Associate Director, QA Computer System Validation, Ultragenyx

    The belief that Data Integrity is not required in early phase development must be challenged. Long before a Regulatory submission or PAI occurs, organizations should build a strong Data Culture and Data Integrity awareness in early phase operations. How do you ensure clinical data collected via Virtual Data Capture (VDC) methodology will stand up to Regulatory scrutiny? What actions can you take to detect failure modes in in your pre-submission data?

    Wearable technology such as glucose monitors and other patient-centric data collection devices pose unique data integrity challenges. In this breakout session, we will discuss the importance of data process mapping as a tool for detecting potential data integrity risks and issues and review an audit case study on wearable technology failure modes.

    Breakout 2: Risk-Based Data Governance
    Moderator/Speaker: Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA

    Data integrity control strategies are expected to be commensurate with risk. However, all GxP information and data, even data classified as low risk, must comply with data integrity requirements. Further, “low” risk data in context with negative data integrity trends or lapses can result in a high level of impact that may place product quality and the safety of patients at risk. Manufacturers that may consider their operations “low” risk are thus expected to implement strategies that assure data integrity and reliability. Without a scientifically sound approach to data integrity compliance, such as a Data Governance program and initiatives to foster a Data Culture, “low” risk data may quickly become “high” risk data.

    In this breakout session, participate in hands on case studies to understand expectations and risk-based Data Governance strategies for “low” risk manufacturers.

    15:45 – 16:15 | Refreshment Break

    16:15 – 17:30 | P3: Data Culture: People and Risk
    Moderator: Meg Gallwitz, Principal Consultant, JAG Healthcare Consulting, LLC

    Quality culture is a critical element of ‘Data Integrity by Design’, yet many organizations are unsure how to achieve cultural excellence in context with Data Governance and are unprepared to navigate the potential impact of cultural risks that may impact data integrity compliance.  

    Assessing the full extent of cultural risks within an organization often requires collaboration and crossover of functional areas that traditionally operate as separate and distinct. Waiting until a risk presents to establish that first point of crossover may result in critical delays, confusion and fear among various stakeholders.  Organizations should strive to establish a proactive strategy with all potential stakeholders, including Quality, Operations, HR, Safety, and Legal to establish roles and responsibilities for managing cultural risk as well as standardized tools for collecting and responding to cultural signals and data. During this session we will explore people and risk within a Data Culture, and hear from Legal experts, understand Regulatory expectations and learn about innovative ways in which some companies are proactively managing cultural vigilance in their organization.

    16:15 | Data ‘Cultural’ Governance
    Meg Gallwitz, Principal Consultant, JAG Healthcare Consulting, LLC

    16:25 | Panel Discussion
    Peter E. Baker, MS, President, Live Oak Quality Assurance
    Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA
    Thomas J. Cosgrove, JD, Partner, Covington & Burling LLP
    Victor R. Gaines, Branch Chief, CDER, U.S. FDA
    Richard N. Love, Director of Business Intelligence, L7 Informatics / Principal, HarborView LLC

    17:30 – 18:30 | Networking Reception


    07:00 – 13:00 | Registration

    07:00 – 08:30 | Continental Breakfast

    07:30 – 08:15 | Breakfast Session: Engage in Building a Pharmaceutical Data Culture - Join the PDA Data Integrity Interest Group!
    IG Leader: Travis A. Frick, MSc, Manufacturing & Quality Operations Leader, Biologics / Cell & Gene Therapy Manufacturing
    Presenter: John Fetherston, Branding + Marketing Associate,The Henrici Group

    Join us for breakfast and learn about the PDA Data Integrity Interest Group! Membership and participation in the Data Integrity IG connects you to a community of individuals who are passionate about Data Integrity; engaging regularly on the topic through online discussion posts in PDA Connect® and in-person meetings held in conjunction with PDA Conferences. Be part of the Data Integrity conversation and fuel the vision of a Pharmaceutical Data Culture!

    08:30 – 10:00 | P4: Data Culture: Foundation for Advanced Technologies and Innovation
    Moderator: Ulrich Köllisch, PhD, Manager Data Integrity, GxP-CC

    Digital transformation can pave the way to efficient, informed decision making and regulatory compliance. In an advanced state, an organization that recreates its mission and ways of working through the adoption of digital technologies empowers their data and fuels innovation. Reimagining an organizational culture versed and engaged in the application of technologies such as AI/ML to expansive sets of regulated GxP-data requires individuals to be empowered with fundamental knowledge of “how” data is transformed, “how” technologies work, and "where" to start.

    In this session, through industry and Regulatory perspectives, we explore the building blocks of data culture to unlock data as an asset and realize compliant, advanced digital technologies.
    08:30 | Digital Transformation for Quality 
    Bob Buhlmann, Head of Quality Digital Systems, AstraZeneca

    09:00 | Digital Transformation: Challenges and Strategies to Mitigate Data Integrity Risk
    Krishna Ghosh, PhD, Senior Reviewer and Subject Matter Expert, CDER, U.S. FDA

    09:30 | Q&A

    10:00 – 10:30 | Refreshment Break

    10:30 - 11:30 | Quality Intelligence
    Moderator/Presenter: Ulrich Köllisch, PhD, Manager Data Integrity, GxP-CC
    Peter E. Baker, MS,
    President, Live Oak Quality Assurance
    Kir F. Henrici,
    CEO, The Henrici Group

    Quality intelligence facilitates knowledge by bringing together different data sources. This breakout will demonstrate some case studies and real-life challenges.

    11:30 – 11:45 | Break

    11:45 – 13:00 | P5: Data Culture: The Business Case for Leadership (Working Lunch)
    Moderator: Kir F. Henrici, CEO, The Henrici Group

    As the Data Integrity Workshop draws to a close some may ask, “What am I going to do on Monday?” This panel provides an opportunity to discuss why Leadership should adopt an organizational vision to realize a Data Culture and “How.” Through questions and answers, important workshop takeaways, and insights from individuals managing data integrity and cultural change, understand the business case for investing in Data Culture and strategic next steps.

    11:45 | Panel Discussion
    Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA
    Bob Buhlmann, Head of Quality Digital Systems, AstraZeneca
    Thomas J. Cosgrove, JD, Partner, Covington & Burling LLP
    Richard N. Love, Director of Business Intelligence, L7 Informatics / Principal, HarborView LLC
    Yash Sabharwal, PhD, Co-Founder & CEO, QbDVision, Inc.
    Hui-I K. Tom, Chemist, OPQ, CDER,U.S. FDA

    12:45 | Closing Remarks from Workshop Chair
    Kir F. Henrici, CEO, The Henrici Group

Highlighted Speakers

Peter E. Baker
Peter E. Baker
Live Oak Quality Assurance
Sandra A. Boyd
Sandra A. Boyd
Thomas J. Cosgrove
Thomas J. Cosgrove
Covington & Burling LLP
Krishnakali Ghosh
Krishnakali Ghosh
Kir F. Henrici
Kir F. Henrici
The Henrici Group
Amanda McFarland
Amanda McFarland
ValSource, Inc.
Ndidi Rickert
Ndidi Rickert
Hui-I K. Tom
Hui-I K. Tom

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this event, attendees will be able to:

    • Understand the essential relationship between Data Governance and Quality Culture
    • Understand the current regulatory climate in regard to Data Governance and Quality Culture
    • Discuss proactive, tactical approaches to Data Governance and Quality Culture to include monitoring, and responding to, signals that may lead to data integrity compliance issues
    • Discuss strategies on how to integrate Data Governance based utilizing a modern Quality Management System through mechanisms of detection, correction and prevention
    • Understand Quality Risk Management, Knowledge Management and Data Management as enablers for Data Governance
    • Engage on advanced data “topics” including big data and AI
  • Who Should Attend
    • Global and site-level leadership responsible for Data Governance programs
    • Individuals responsible for organizational change and Quality Culture
    • GxP Business Process Owners (“Data Owners”) and Product Quality Leaders
    • Quality and Data Integrity Compliance professionals
    • Information Technology / Engineering / Data Management personnel
    • Computer Systems Validation professionals
    • Batch Release and Qualified Persons
    • Quality Risk Managers
    • Automation Leads
    • Auditors
    • Trainers
    • Quality Control professionals
    • Regulatory & Compliance Counsel
    • Data Scientists

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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
Phone: +1 (202) 898-9000

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 $322 USD for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, 15 August 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 15:00; check-out time is 12:00.

    To make reservations, individuals may click on the reservation link above or call the Renaissance at +1 (202) 898-9000. Be 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 in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. Set in the heart of the city, our upscale hotel is steps from Capital One Arena, Penn Quarter and the Walter E. Washington Convention Center. From museums to entertainment, this is the perfect base for exploring downtown D.C.

    At days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi.

How to Get Here

By Air

Ronald Reagan Washington National Airport (DCA) is approximately 5 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Washington Dulles International Airport (IAD), 27.8 miles away, and Baltimore/Washington International Thurgood Marshall Airport (BWI), 34 miles away. Taxi fares from DCA are approximately $25 USD one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 USD and from BWI about $85 USD.

By Car

The Renaissance Washington, DC Downtown Hotel is located at 999 9th Street, NW, Washington, DC 20001. Parking is available onsite at the following rates: *Daily Self Parking - $35 USD *Daily Valet Parking - $60.18 USD

Other Options

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 USD one way to Ronald Reagan Washington National Airport (DCA). Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit


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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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