ISPE Expert Xchange GAMP®:  Implementing Data Integrity by Design 

Next-Generation Virtual Experience

Learning Level: Intermediate
Session Length: 4 hours


  • How do CSA principles transfer to real life success? 
  • How does nomenclature impact the usability and quality of data generated by business processes? 
  • How do I create a process map for data integrity? 

The ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design will answer these questions and more!  Hear from leading industry subject matter experts present information and case studies explaining how to generate process maps and data flows, how to implement data nomenclature and analytics within your organization, and how to apply Computer Software Assurance (CSA) principles to validating your data integrity controls, and more.  

In addition, YOU get a seat at the table with these leading industry subject matter experts and your peers during the interactive topic-focused small group discussions where you will gain first-hand strategic insights and walk away with new connections, and actionable takeaways that will directly impact you, your organization, and the pharma industry. 

First-hand Strategic Insights & Actionable Takeaways 

  1. Learn how to build and leverage process maps for Data Integrity by Design. 
  2. Learn how planning and managing data nomenclature can create significant gains in the usability and quality of the data generated by the business process, thus facilitating the effective use of data analytics and knowledge management. 
  3. Learn how CSA principles translate into real life success. 
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies
Problem-Solving
Problem-Solving

Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!


Agenda

  • Workshop Welcome
    Lorrie L. Vuolo-Schuessler
    Senior Director Computer Systems Quality and Data Integrity
    Syneos Health
    Chair
  • Process Mapping and Data Flows Case Study
    Lorrie L. Vuolo-Schuessler
    Senior Director Computer Systems Quality and Data Integrity
    Syneos Health
    Charlie C. Wakeham
    APAC GxP Compliance Manager
    Waters Corporation

    This presentation will step will walk you through developing a process map and defining data flows as a foundation to Data Integrity by Design.

    55-minute case study will be followed by a 30-minute Q&A session.

  • Data Nomenclature and Data Analytics
    Lorrie L. Vuolo-Schuessler
    Senior Director Computer Systems Quality and Data Integrity
    Syneos Health
    Chair
    Mark E. Newton
    Principal
    Heartland QA

    Mark will explain how defining data nomenclature as part of Data Integrity by Design is essential for the later use of data analytics to detect DI issues and process irregularities. 30-minute presentation followed by a 30-minute Q&A session.

  • CSA Case Study
    Charlie C. Wakeham
    APAC GxP Compliance Manager
    Waters Corporation
    Chair
    Khaled Moussally
    Executive Vice President Clients & Regulatory Relations
    Compliance Group Inc
    Stephen J. Cook
    Vice President, Quality & Computer Compliance
    Compliance Group Inc.

    This case study will provide practical examples of how critical thinking and CSA approaches can be applied to computerized systems validation to verify data integrity technical controls.

    A  downloadable sample PDF will be provided to use during the case study to apply the new knowledge you’ve learned in the Expert Xchange and apply your own critical thinking to assess the requirements.

    40-minute case study will be followed by a 30-minute Q&A session.

  • Workshop Close
    Charlie C. Wakeham
    APAC GxP Compliance Manager
    Waters Corporation
    Chair

ISPE Expert Xchange Session Chairs & Speakers

Charlie C. Wakeham
APAC GxP Compliance Manager
Waters Corporation
Chair
Lorrie L. Vuolo-Schuessler
Senior Director Computer Systems Quality and Data Integrity
Syneos Health
Chair
Khaled Moussally
Executive Vice President Clients & Regulatory Relations
Compliance Group Inc
Speaker
Stephen J. Cook
Vice President, Quality & Computer Compliance
Compliance Group Inc.
Speaker
Mark E. Newton
Principal
Heartland QA
Speaker

ISPE Expert Xchange Rates

ON DEMAND ACCESS FOR 90 DAYS

Member $199
Nonmember   $249 
Academia/Emerging Economy/Government*  $120
Recent Graduates* $75
Student* $75

Buy on Demand

*ISPE Membership is required for these registration rates.


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