2021 PDA Data Integrity Workshop

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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.

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.

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Standard Registration

Member Price

$837

GovernmentMember Only

$392

Health AuthorityMember Only

$392

StudentMember Only

$157

AcademicMember Only

$392

Non-Member

$1,033

See Qualifying Criteria for Member Types.

Day 1

Wednesday, 22 September

09:45 – 11:30 EDT | 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.’

09:45 – 09:50 EDT | Welcome and Overview from Workshop Chair
Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance

09:50 – 10:20 EDT | Data Governance: Exploiting the value of Metadata using Data Analytics
James Strickland, Data Integrity Program Lead, Pfizer Inc

10:20 – 11:05 EDT | 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

11:05 – 11:30 EDT | Q&A

11:30 – 11:45 EDT | Break

11:45 – 13:15 EDT | 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 EDT | Fit for Purpose: Enabling Optimized Data Usage through a Modern Validation Approach
Jennifer M. Rheaume, MBA, Validation Engineer III, AstraZeneca

12:15 – 12:45 EDT | Small Systems with Critical Data Assets: Innovation for Data Integrity and Usability
Brian J. Kear, MBA, Global Business Development Lead - Lab Software, Mettler-Toledo

12:45 – 13:15 EDT | Q&A

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

Day 2

Thursday, 23 September

09:45 – 11:30 EDT | 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.
09:45 – 09:50 EDT | Day 1 Recap
Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance

09:50 – 10:25 EDT | The Brain Behind the Curtain: Unlocking the Data Quality Culture
Lori Richter, BS, Director Risk Management and GxP Global Learning, Ultragenyx Pharmaceutical

10:25 – 11:00 EDT | The Human Factors of Expert Decision Makers
Kenneth R. Allendoerfer, PhD, Manager, Human Factors Branch, Federal Aviation Administration William J. Hughes Technical Center

11:00 – 11:30 EDT | Q&A

11:30 – 11:45 EDT | Break

11:45 – 13:30 EDT | 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 EDT | 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

12:45 – 13:15 EDT | Q&A Panel
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
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 EDT | Closing Remarks from Workshop Chair
Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance
Agenda is subject to change.

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