The Stage 1 workshop is focused on developing a solid understanding of the foundations of GXP data governance and data integrity assurance outlined in the newly published EU Annex 11 and associated PIC/s Guide. In this two-day workshop we discuss current regulatory expectations and guidance, including the basics of DI: the ALCOA principles, with the goal of developing a comprehensive understanding of how to operate efficiently within a GXP regulated environment. We discuss risk-based approaches to ensure regulatory compliance; referencing current regulations, regulatory actions, and harmonized guidance. Specific sub-topics include:
A modern interpretation of 21 CFR Part 11/EU Annex 11
FDA GMP regulation 21 CFR Part 211.68 – computerized systems in GMP
Guideline on computerised systems and electronic data in clinical trials (EMA, 2023)
FDA Draft Guidance: “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” (2024)
PIC/s Final Guidance (June 2021): Good Data Management
Data Integrity expectations for GLP
Quality Risk Management & ICH Q9:
Design
Operation
Monitoring
Strategies for metadata (e.g. audit trail) review
Critical Thinking and Data Integrity
Each day will include hands-on case studies where participants will practice application of data integrity principles in real-life scenarios.
The Stage 1 workshop is designed for personnel engaged in regulated GXP activities (employees who create, review or approve GXP data), including employees who support GXP activities, such as IT professionals. This workshop moves well beyond the ALCOA+ principles with a heavy emphasis on quality risk management and lean manufacturing principles, and is relevant to both new and experienced employees as we discuss data integrity from a regulator’s perspective. This workshop is designed to set individuals up for success in an evolving regulatory environment that is rapidly adapting to new technologies.
Each topic is presented and discussed from a regulatory patient-focused perspective, with the primary objective being gaining the confidence necessary to solve complicated GXP problems (e.g., hybrid systems) and defend governance strategies during regulatory inspections and/or internal audits. When employees are able to confidently describe “why we do what we do” from a risk-based and patient-centric perspective, even when dealing with imperfect systems, inspectors are better able to understand the site’s rationale, reducing misunderstandings and ultimately leading to improved regulatory/audit outcomes.
Who should join the Stage 1 Fundamentals course? Individuals working within a GXP environment that:
are required to operate efficiently within a regulated environment (QC, Manufacturing, Quality, Warehouse, Engineering, IT, etc.) where the integrity of data (paper or electronic) is considered critical to patient safety,
responsible for the development or monitoring of clinical or non-clinical studies,
may (or are) tasked with contributing to investigations (e.g., deviations) that include data integrity concerns,
perform or participate in internal or external audits,
participate in computer system validation or IT systems management,
or field data integrity related questions (written or verbal) during regulatory or customer interaction.