34th SQA Annual Meeting and Quality College

RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units

Description
Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT savvy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate "what to look for" for a variety of audits, both technology-focused and more conventional areas in which technology has "encroached."

Objectives
At the end of the course, the participants shall be able to: 

• Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.
• List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)
• Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)
• Define and list the desired skill set for the eData Audit Team
• Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported
• Outcomes - AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.

Target Audience
Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.

Agenda

• Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.
• List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)
• Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)
• Define and list the desired skill set for the eData Audit Team
• Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes - AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.