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2021DataIntegrity-1988x680

2021 PDA Data Integrity Workshop

Sep 22 - Sep 23, 2021
Eastern Standard Time | Online
  • Virtual
  • Online

Overview

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 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.

Exciting new opportunities for people, process, products, and technologies 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.  But meaningful Data Governance and a ‘Data Quality Culture’ cannot be achieved solely by Information Technology or the Quality Unit.  Instead, Business Process Owners (i.e., “Data Owners”)--who understand the intended use(s) of their data and potential risks to patients, products, and application integrity--must play a primary role in data process improvements and data integrity risk reductions. This collaborative journey requires Management Commitment and modern, agile, flexible, and scalable Quality Risk Management strategies and inspired Cultural Change Management.

This conference will be comprised of interactive case studies, presentations, and panel discussions.  Come join us to share experiences, learnings, and ideas.

Agenda

  • Day 1
  • Day 2
  • Wednesday, 22 September

    9:45 – 11:30 | P1: Data Ownership Across the Product Life Cycle
    Moderator: Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance

    Data Owners use data for key decisions that affect product quality, patient safety, and application integrity. Join this interactive session to learn about modern approaches, such as data analytics and metadata review, to facilitate the usefulness of data in decision making and identification of risks. U.S. FDA will also discuss data ownership across the product lifecycle and why continued approval of applications hinges on the reliability of data generated, controlled, and maintained throughout a drug’s lifecycle. U.S. FDA will explore various types of submissions to the Agency, responsibilities of data owners, and important elements of the ‘long game.’

    9:45 – 10:00 | Welcome and Overview from Workshop Chair
    Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance

    10:00 – 10:30 |Tools for Data Owners: Data Analytics and Exploiting the Value of Metadata
    James Strickland, 
    Senior Director Data Integrity Program Lead, Pfizer

    10:30 – 11:00 | Data Owner’s Manual: Applications are Not ‘One and Done’
    Aditi S. Thakur, MS,Acting Quality Assessment Lead, CDER, U.S. FDA
    Karen K. Takahashi, Senior Policy Advisor, CDER, U.S. FDA

    11:00 – 11:30 | Q&A

    11:30 – 11:45 | Break

    11:45 – 13:15 | P2: Applying Data Integrity to Realize Data as an Asset
    Moderator: Kir F. Henrici, CEO, The Henrici Group and Mark E. Newton, Owner, Heartland QA

    This session explores the value of applying data integrity foundations to business applications to create data as an asset. Efficient use of generated data across the organization assures robust monitoring, continuous improvement, and the drive for innovation.

    11:45 – 12:15 | Fit for Purpose: Enabling Optimized Data Usage through a Modern Validation Approach
    Jennifer M. Rheaume, MBA,
    Validation Engineer III, AstraZeneca

    12:15 – 12:45 | Small Systems with Critical Data Assets: Innovation for Data Integrity and Usability
    Brian Kear,
     Mettler Toledo

    12:45 – 13:15 | Q&A

    13:15 – 13:30 | Day 1 Closing Remarks
    Monica J. Cahilly, MS,
    President/Consultant, Green Mountain Quality Assurance

  • Thursday, 23 September

    09:45 – 11:30 | P3: Data Quality Culture
    Moderator: Julie C. Maurhoff, CQA, Vice President, GxP Compliance, Ultragenyx Pharmaceutical

    Data Integrity is a core element of Quality Culture and in many ways, boils down to good risk management and decision making. How do you create a culture that facilitates staff expertise and high performance? How do you ensure that your automation is designed to facilitate quality data? This session, led by experts from Pharma and the FAA, will lean into the different human factors that influence, enhance, and dissuade our ability to sustain Data Integrity and drive Quality Culture.
    9:45 – 10:00 | Day 1 Recap
    Monica J. Cahilly, MS,
    President/Consultant, Green Mountain Quality Assurance

     

    10:00 – 10:30 | The Brain Behind the Curtain: Unlocking the Data Quality Culture
    Lori Richter, BS, Director Risk Management and GxP Global Learning, Ultragenyx Pharmaceutical

    10:30 – 11:00 | The Human Factors of Expert Decision Makers
    Kenneth Allendoerfer, PhD, Director of the Human Factors Branch, FAA

    11:00 – 11:30 | Q&A

    11:30 – 11:45 | Break

    11:45 – 13:30 | P4: 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 U.S. FDA regulators on current regulatory and compliance perspectives on data integrity, including discussions of emerging U.S. FDA inspectional approaches for data integrity, new tools and techniques, perspectives on data materiality, U.S. FDA expectations for remediation of data integrity issues, and examples of recent data integrity observations and case studies. In addition, regulators will also share data integrity challenges encountered during the pandemic and their thoughts on pivotal questions, such as: what does the future look like with regard to data integrity and U.S. FDA inspections? Will regulators verify the integrity of data submitted during the pandemic? and How will U.S. FDA perform data validity checks?

    11:45 – 12:45 | Brooke Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

    12:45 – 13:15 | Q&A Panel
    Brooke Higgins, MS,
    Senior Policy Advisor, CDER, U.S. FDA
    Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA
    Karen K.Takahashi, Senior Policy Advisor, CDER, U.S. FDA
    Aditi S. Thakur, MS, Acting Quality Assessment Lead, CDER, U.S. FDA

    13:15 – 13:30 | Closing Remarks from Workshop Chair
    Monica J. Cahilly, MS, 
    President/Consultant, Green Mountain Quality Assurance

Highlighted Speakers

Brooke K. Higgins
Brooke K. Higgins
U.S. FDA
Jennifer M. Rheaume
Jennifer M. Rheaume
AstraZeneca
Lori Richter
Lori Richter
Ultragenyx Pharmaceutical
Carmelo Rosa
Carmelo Rosa
U.S. FDA
Karen K. Takahashi
Karen K. Takahashi
U.S. FDA
Aditi S. Thakur
Aditi S. Thakur
U.S. FDA

Learning Objectives

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

  • Understand roles and responsibilities for Data Owners in management of data and knowledge across product life cycle
  • Understand the current regulatory climate and remediation expectations and to define what is needed to engrain Data Integrity into the Quality Management System and Culture.
  • Discuss proactive approaches for Data Owners in optimizing computerized systems and data process governance
  • Promote a holistic understanding of the challenges faced by the industry in detecting and remediating data integrity risks
  • 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 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

Registration Fees

Register Now
Early Registration
Registration Type Price by 31 July 2021
Member $598
Non-member $738
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Early Career Professional
Member
$299
Regular Registration
Registration Type Regular Registration
Price after 31 August 2021
Member $837 $1,076
Non-member $1,033 $1,328
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Early Career Professional Member
$419 $538

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