Other Courses - Eventura

GCP E6(R3): What Inspectors Will Test in Sponsor Oversight

_______________________________________________________________________________________________________ 📅 October 14, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

Change Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs

_______________________________________________________________________________________________________ 📅 October 29, 2026 | 🕒 12 PM Eastern Time US | 🕒 4 PM GMT | ⏳ 90 Minutes

CAROLYN TROIANO

Risk Management for AI/ML Medical Devices: Applying ISO 14971 and ISO/TS 24971-2:2026

_______________________________________________________________________________________________________ 📅 October 06, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

MEREDITH CRABTREE

Design Changes After Clearance: When a New 510(k) Is Required

_______________________________________________________________________________________________________ 📅 October 09, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

510(k)s, DeNovos, and PMA Submissions: Practical Considerations for Modern Device Classifications and Market Authorization

_______________________________________________________________________________________________________ 📅 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

FDA Inspections Under QMSR: What Changes for Risk Management, CAPA, MDRs, and Design Controls

_______________________________________________________________________________________________________ 📅 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

From Inspection Observation to 483 Response: Evidence Triage, Immediate Corrections and Commitments You Should Not Make

_______________________________________________________________________________________________________ 📅 October 29, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

Vendor Assurance for AI and Cloud-Based GxP Systems: What You Can Leverage, Challenge, and Independently Verify

_______________________________________________________________________________________________________ 📅 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

Validating Interfaces Between GxP Systems: Data Transfers, APIs, Middleware, and Integration Failures

_______________________________________________________________________________________________________ 📅 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

Risk Management for AI/ML Medical Devices: Applying ISO 14971 and ISO/TS 24971-2:2026

_______________________________________________________________________________________________________ 📅 October 06, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

MEREDITH CRABTREE

EU MDR Technical Documentation: Keeping Risk, Clinical and Design Records Consistent Through Product Changes

_______________________________________________________________________________________________________ 📅 September 14, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes