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2020 PDA Data Integrity Workshop

Data Governance Programs: Fit for Innovation

Sep 02 - Sep 10, 2020
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online
  • The Americas
Program Highlights

The 2020 PDA Data Integrity Workshop is going Virtual! Join us for this four-part Webinar Series on Sept. 2, Sept. 3, Sep. 9, and Sept. 10. Registration is now open!


Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity is a foundational requirement of all GXP regulations, there continues to be an increased focus on this topic both from a regulatory and industry perspective as data integrity breaches still drive a significant number of Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations.  Moreover, additional guidelines and regulations have been published to establish Data Integrity Standards.

As data integrity programs mature, firms will need to consider transitioning from a reactive model (assessments) to a preventative model and engrain data integrity into their Quality Management Systems and Culture, potentially modernizing historical control strategies to address current controls and risk scenarios. This will lead to exciting new opportunities for people, process, products, and technologies to emerge through the introduction of Data Governance, Data Process Design, Data Analytics, and Big Data initiatives—all with an intent to optimize the availability, usability, and reliability of data to enhance Management Review and  Knowledge Management Programs.  This transformation journey will demand modern, agile, flexible, and scalable Quality Risk Management strategies and inspired Cultural Change Management.


  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Wednesday, September 2 - Part 1

    10:30 a.m. – 11:45 a.m.
    P1: Data Governance: Journey to Enhanced Processes and Products
    Moderator: Kir Henrici, CEO, The Henrici Group

    Join this session to hear from MHRA and industry on the topic of data governance and gain valuable insights for a pragmatic, integrated approach to data governance across the product lifecycle in support of process verification and process improvement.

    10:30 a.m. – 10:55 a.m.
    Now and the Future
    Tracy Moore, Expert GMP Inspector, MHRA

    10:55 a.m. – 11:20 a.m.
    Development of Product and Process Knowledge throughout the Product Lifecycle using Data Collection and Analysis for Continuous Process Verification and Improvement
    Patrick Blacha, Eli Lilly and Company and Anne V. Renton, MBA, Research Scientist, Eli Lilly and Company

    11:20 a.m. – 11:45 a.m.

    11:45 a.m. – 12:00 p.m.

    12:00 p.m. – 1:00 p.m.
    Interactive Session 1: Knowledge Management - Data Insights, Decisions, and Continuous Improvement Actions
    Moderator: Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance

    Speaker: Travis A. Frick, MSc, Head Data Integrity & Analytics, GlaxoSmithKline

    In this session, attendees will execute a practical case study within manufacturing operations demonstrating targeted improvements to increase knowledge management. Attendees will improve process outputs to deliver meaningful information and insights and increase control strategy by applying data integrity by design through the pharmaceutical quality management system.


  • Thursday, September 3 - Part 2

    10:30 a.m. – 11:45 a.m.
    Interactive Session 2: Quality Data: The Secret Sauce of a Robust Pharma Manufacturing Process
    Moderator: Kir Henrici, CEO, The Henrici Group
    Speaker: Toni Manzano, PhDCo-founder and CSO, Bigfinite

    How do you design a robust manufacturing process in Pharma and Biotech? A theoretical answer would need to consider all the involved variables and constants that determine the system to establish the dynamic state equations that characterize the process. However, the laws of physics, chemistry and engineering force us to make approximations because the available data does not always explain the entire context. Obtaining real-time data of all the variables that must be taken into account to apply the theoretical model is an arduous, if not impossible task as the multitude of information sources are usually not integrated or not available. The application of Artificial Intelligence in industrial environments has drastically changed this scenario.

    Join this session for a case-study of the granulation process where the application of multiple Artificial Intelligence algorithms informs improving the manufacturing process utilizing good quality data.

    11:45 a.m. – 12:00 p.m.

    12:00 p.m. – 1:00 p.m.
    Interactive Session 3: Data Integrity: From Details Revealed via Data Forensics to Big Picture 
    Moderator: Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance

    Moderator: Mark E. Newton, Owner, Heartland QA

    We have blind spots in our thinking and our Quality Systems. These come from our approach, backgrounds and experiences, organizational structure, project plans, governance, and culture. In the ideal world, we note these spots in each other and collectively remove them. This session will view a manufacturing facility with data integrity issues (but doesn’t know it) from QC data forensics outward to the bigger picture. We will start with simple tools and techniques for data forensic analysis of QC analytical data and metadata to see a data integrity issue, then through the small bits of information provided by people in different areas of the company, we will work outward to the environment that created the data issues. The goal is to demonstrate how decisions that seem completely unrelated to data integrity can create an environment where integrity lapses live and discuss how the data samples and metrics provided in the workshop can help us see the bigger picture.

  • Wednesday, September 9 - Part 3

    10:30 a.m. – 11:45 a.m.
    P2: Current Regulatory and Compliance Perspectives on Data Integrity in Changing Times
    Moderator: Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance

    Join us to hear from FDA and former FDA regulators on current regulatory and compliance perspectives on data integrity, including discussions of emerging U.S. FDA inspectional approaches for data integrity during the global pandemic, new tools and techniques, perspectives on data materiality and quality risk management approaches to remediation, and examples of recent data integrity observations.

    10:30 a.m. – 11:05 a.m.
    Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

    11:05 a.m. – 11:30 a.m.
    Data Materiality and Risk-Based Data Governance, a Practical Approach
    Tom Cosgrove, JD, Partner, Covington & Burling LLP and formerly with the FDA

    11:30 a.m. – 11:45 a.m.

    11:45 a.m. – 12:00 p.m.

    12:00 p.m. – 1:00 p.m.
    Interactive Session 4: Agile Development and Computer Software Assurance
    Moderator: Mark A. DiMartino, MS, Director, Quality Data Sciences, Amgen Inc.


    Carrie Babcock, Senior Specialist Quality Assurance, Amgen Inc.
    Brian T. McBreen, Jr., Director, Knowledge Analytics, Amgen Inc.
    Sebastian R. Hanet, Senior Associate Data Scientist, Amgen Inc.

    This session will be a panel discussion on the initiation, development, suitability for use demonstration and lifecycle management of advanced analytics/AI based tools that are used to support GMP operations. The business processes and procedures used will be discussed, along with discussion of a practical use case. Key considerations on how to demonstrate software assurance will be discussed. The audience will be invited to ask questions throughout the session and the moderator will pose questions to the panel.

  • Thursday, September 10 - Part 4

    10:30 a.m. – 11:45 a.m.
    Interactive Session 5: Critical Thinking Applied to Data Maps and Audit Trail Reviews
    Moderator: Els Poff, Executive Director, Data Integrity Center of Excellence, Merck & Co., Inc.
    Speaker: Michael Maltman, Director, Data Integrity Center of Excellence, Merck & Co., Inc.

    During this session we will utilize critical thinking in reviewing the process map and data management controls to apply a risk-based approach to the Quality review, of audit trails associated with manufacturing systems.

    11:45 a.m. – 12:00 p.m.

    12:00 p.m. – 1:00 p.m.
    Interactive Session 6: CGMP Data: Keeping it Real
    Moderator: Aditi S. Thakur, MS, Acting Quality Assessment Lead, CDER, U.S. FDA


    Karen K. Takahashi, MS, Senior Policy Advisor, CDER, U.S. FDA and Amy B. Muhlberg, PhD, Staff Fellow, CDER, U.S. FDA

    This session will explore the FDA’s perspective on the reliability of data submitted in or omitted from drug applications. Participants will come away with a better understanding of the agency’s thinking about the reliability of data submitted in or omitted from drug applications and about how they may think more critically about data that they maintain, submit to the agency, and the importance that this data plays throughout the product lifecycle.

Highlighted Speakers

Thomas J. Cosgrove
Thomas J. Cosgrove
Covington & Burling LLP
Travis A. Frick
Travis A. Frick
Biologics / Cell & Gene Therapy Manufacturing
Brooke K. Higgins
Brooke K. Higgins
Michael Maltman
Michael Maltman
Merck & Co., Inc.
Toni Manzano
Toni Manzano
Aizon and AFDO/RAPS Healthcare Products Collaborative
Mark E. Newton
Mark E. Newton
Heartland QA
Carmelo Rosa
Carmelo Rosa
Karen K. Takahashi
Karen K. Takahashi

Learning Objectives

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

  1. Understand the current regulatory climate and remediation expectations and to define what is needed to ingrain Data Integrity into the Quality Management System and Culture.
  2. Promote a holistic understanding of the challenges faced by the industry in data integrity.
  3. Discuss strategies on how to utilize Quality Risk Management to prevent Data Integrity issues and establish a quality culture which promotes Data Integrity as a core value.

Who Should Attend

  • GxP Business Process and System Owners
  • Compliance professionals
  • Batch Release and Qualified Persons
  • Quality Risk Managers
  • Automation Leads
  • Auditors
  • Trainers
  • Quality Control professionals
  • Regulatory & Compliance Counsel
  • Data scientists

Registration Fees

Registration Type Price
Member $1196
Non-member $1475
Young Professional Member $598
Student Member $224
Student Non-Member $248
Gov't/Health Auth./Academic Member $560
Gov't/Health Auth. Non-Member $560
Academic Non-Member $640

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