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2021DataIntegrity-1988x680

2021 PDA Data Integrity Workshop

Sep 30, 2021
Washington, DC

  • Workshop
  • The Americas

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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

  • Thursday, 30 September

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

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

    10:00 – 10:30 | Industry Representative Invited

    10:30 – 11:00 | Aditi S. Thakur, MS, Acting Quality Assessment Lead, CDER, U.S. FDA

    11:00 – 11:30 | Q&A

    11:30 – 12:00 | Break

    12:00 – 13:00 | P2: Data Analytics & Computing for Innovation
    Moderator: Kir Henrici, CEO, The Henrici Group

    12:00 – 12:20 | Jennifer M. Rheaume, MBA, Validation Engineer III, AstraZeneca

    12:20 – 12:40 | Regulatory Representative Invited

    12:40 – 13:00 | Q&A

    13:00 – 14:00 | Lunch

    14:00 – 15:00 | P3: Data Quality Culture
    Moderator: Julie C. Maurhoff, CQA, Vice President, GxP Compliance, Ultragenyx Pharmaceutical

    14:00 – 14:20 | Lori Richter, Director, GxP Global Learning and Risk Management, Ultragenyx Pharmaceutical

    14:20 – 14:40 | Industry Representative Invited

    12:40 – 13:00 | Q&A

    15:00 – 15:30 | Break

    15:30 – 17:15 | P4: Data Risk Management & Improvement
    Moderator: Monica J. Cahilly, MS,
    President/Consultant, Green Mountain Quality Assurance

    15:30 – 16:30 | Regulatory Representatives Invited

    16:30 – 17:00 | Q&A

    17:00 – 17:15 | Closing Remarks from Workshop Chair
    Monica J. Cahilly, MS,
    President/Consultant, Green Mountain Quality Assurance

Additional Information

  • Learning Objectives

    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

    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

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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.


Washington, DC

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Registration Fees

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
Young 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
Young Professional Member $419 $538

* 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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Tel: +1 (301) 656-5900 ext. 115
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