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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 agenda is now available!

Overview

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.

Agenda

  • Day 1
  • Day 2
  • THURSDAY, 15 SEPTEMBER

    07:00 – 17:30 | Registration

    07:00 – 08:30 | Continental Breakfast

    08:15 – 10:00 | P1
    Moderator: Doreen Newhouse, Principal Consultant, DN DI Consulting LLC

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

    08:30 | Denise Brooks, Consultant

    09:00 | Peter Baker, 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

    Speaker: Steven R. Mendivil, BS, Senior Advisor for Quality, Amgen Inc.

    11:30 –12:30 | B1: Process Intensification: Increasing Yield per Unit
    Moderator: Jennifer M. Rheaume, MBA, Principal Validation Engineer, AstraZeneca

    Speakers:
    Richard N. Love, Principal, HarborView LLC
    Regulatory Representative Invited

    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 | Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    13:55 | Doreen Newhouse, Principal Consultant, 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: Laying a strong foundation for Virtual Data Capture (VDC)
    Moderator: Julie C. Maurhoff, Vice President, GxP Compliance, Ultragenyx

    Speakers: Ndidi Rickert, Associate Director, Quality Culture Excellence, Ultragenyx and Tara Safakish, Associate Director, Quality Systems, Ultragenyx

    In today’s world, and the interrelation of computerized systems, there is an increased emphasis on Data Integrity, Interpretability, and Interoperability. As such, emphasis must be on the intended use of patient-centric computerized systems or tools, understanding the time required to perform phase appropriate risk assessment of computer systems validation (software) to protect data that matters. During this breakout session, we will be discussing our experience with capturing data virtually, including hybrid and/or Decentralized Clinical Trials (DCT).
    Breakout 2
    Moderator: Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA

    15:45 – 16:15 | Refreshment Break

    16:15 – 17:30 | P3
    Moderator: Meg Gallwitz, Principle Consultant, JAG Healthcare Consulting, LLC

    16:15 | Cultural Vigilance

    16:30 | Panel Discussion
    Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA
    Tom J. Cosgrove, JD, Partner, Covington & Burling LLP
    Victor R. Gaines, Branch Chief, CDER, U.S. FDA
    Industry Representative Invited

    17:30 – 18:30 | Networking Reception

  • FRIDAY, 16 SEPTEMBER

    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, Senior Director, Manufacturing Operations, Istari Oncology

    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 informed decision making and regulatory compliance by exploiting new technologies like Digital Twins, Big Data and AI/ML. However, the results are relying on the input data, potentially influenced by human behaviour. In this session we want to explore how data culture which considers data as a valuable asset can be an enabler for innovation and Quality Intelligence.

    08:30 | Bob Buhlmann, Head of Quality Digital Computer Related System Strategy, AstraZeneca

    09:00 | Regulatory Representative Invited

    09:30 | Q&A

    10:00 – 10:30 | Refreshment Break

    10:30 – 11:30 | Concurrent Breakout Sessions

    Breakout 1: Quality Intelligence
    Moderator: Ulrich Köllisch, PhD, Manager Data Integrity, GxP-CC

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

    Breakout 2: Foundation
    Moderator: Kir F. Henrici, CEO, The Henrici Group

    Speaker: Toni Manzano, CSO and Co-Founder, Aizon

    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

    11:45 | Panel Discussion

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

     

Highlighted Speakers

Sandra A. Boyd
Sandra A. Boyd
U.S. FDA
Meg Gallwitz
Meg Gallwitz
JAG Healthcare Consulting, LLC
Kir F. Henrici
Kir F. Henrici
The Henrici Group
Ulrich Köllisch
Ulrich Köllisch
GxP-CC
Toni Manzano
Toni Manzano
Aizon
Bethany B. Rexing
Bethany B. Rexing
Eli Lilly and Company
Jennifer M. Rheaume
Jennifer M. Rheaume
AstraZeneca
Ndidi Rickert
Ndidi Rickert
Ultragenyx

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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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
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 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 3:00 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 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. Fuel up for a busy day downtown with breakfast weekdays at Mixx or weekends at Fifteen Squares Restaurant. Our Grand Ballroom, meeting rooms and 11th-Floor Terrace are also available for a host of multi-sensory events, from important conferences to joyful weddings. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi and suites with beautiful terraces.

How to Get Here

By Air

Reagan 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: Dulles International Airport (IAD), 27.8 miles away, and Baltimore-Washington International Airport (BWI), 34 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

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

Other Options

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National. Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com.

Directions

Registration Fees

Regular Price
Registration Type Early Registration After 17 July
Member $1,495 $1,995
Non-Member $1,795 $2,295
Govern./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $995 $995

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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Program Inquiries
  • Brooke Lustig, CMP
    Senior Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
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