510(k)s, DeNovos, and PMA Submissions: Practical Considerations for Modern Device Classifications and Market Authorization
This course helps device teams distinguish among FDA submission pathways and evaluate how classification, risk, clinical evidence, newer technologies, and available submission programs affect regulatory planning and market authorization.
GCP E6(R3): What Inspectors Will Test in Sponsor Oversight
This course helps sponsors establish a clearer oversight strategy, align supplier arrangements with ICH-GCP E6(R3), and prepare documentation and contractual evidence that supports inspection readiness.
Risk Based Quality Management and Risk Based Monitoring under ICH E6 (R3)
This course helps clinical trial teams distinguish RBQM from RBM, identify Critical to Quality factors, and establish a practical implementation approach aligned with ICH E8(R1) and ICH E6(R3).
From Inspection Observation to 483 Response: Evidence Triage, Immediate Corrections and Commitments You Should Not Make
This course strengthens the ability to control the critical period between an emerging FDA inspection concern and the formal response, using available evidence to prioritize actions and make commitments that remain supportable after the inspection ends.
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 CrabtreeChange Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
Determining Root Cause in Sterility Failure Investigations
A practical investigation framework for tracing sterility failures through laboratory, manufacturing, environmental, and contamination-source evidence to establish a defensible root cause, determine the impact on affected batches, and support appropriate corrective actions.
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
Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice
A two-day, risk-based framework for CSV/CSA and GAMP® 5 validation decisions on modern GxP systems — cloud, SaaS, configurable, and AI-enabled platforms — built for inspection readiness.
Carolyn TroianoRecording available
Validating Interfaces Between GxP Systems: Data Transfers, APIs, Middleware, and Integration Failures
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 CollazoRepeat Deviations and OOS: Strengthening RCA-CAPA Effectiveness and Managing Investigation Backlogs | Risk-Based Decisions on When to Investigate Deeper, Escalate, or Close
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