2020 PDA Data Integrity Workshop

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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.

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.

Standard Registration

Member Price


Early Career ProfessionalMember Only


StudentMember Only




See Qualifying Criteria for Member Types.

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].

Day 1

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.


Day 2

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.

Day 3

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.

Day 4

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.

Agenda is subject to change.

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