Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
Avoid FDA 483s by properly configuring and validating GxP-compliant Excel spreadsheets — with live step-by-step setup of audit trails, security features, and data entry verification.
David Nettleton
Complaint Handling and Investigation: Linking CAPA, MDR Reporting, Trend Evaluation, and Recall Considerations
This session examines complaint handling from a lifecycle perspective, focusing on how complaint information drives downstream quality and regulatory decisions.
Meredith Crabtree
Cleaning Validation Lifecycle Control: Monitoring Drift, Method Sensitivity, and Revalidation Decisions
This session examines cleaning validation from a lifecycle perspective, focusing on how organizations maintain confidence in validated cleaning processes long after initial approval.
Meredith Crabtree
Human-in-the-Loop (HITL) in GMP: Maintaining Human Oversight of AI-Assisted Decisions
Human-in-the-Loop is not simply having a person present. Effective HITL requires meaningful human oversight, defined decision authority, documented intervention, traceability, and lifecycle monitoring proportional to GMP risk.
Dr. Ginette CollazoChange Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
Validating Interfaces Between GxP Systems: Data Transfers, APIs, Middleware, and Integration Failures
Repeat Deviations and OOS: Strengthening RCA-CAPA Effectiveness and Managing Investigation Backlogs | Risk-Based Decisions on When to Investigate Deeper, Escalate, or Close
Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
Learn how SPC, Six Sigma, and process data support CGMP production controls — sampling plan justification, verification/validation, and trend analysis for non-conformances, complaints, and CAPAs.
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