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
- Learn how to build and leverage process maps for Data Integrity by Design.
- 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.
- Learn how CSA principles translate into real life success.
Small Group Discussions
Technical Presentations
Case Studies
Problem-Solving
Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!
Agenda
- Workshop Welcome
- Process Mapping and Data Flows Case Study
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
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
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
Chair
ISPE Expert Xchange Session Chairs & Speakers
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