Program Info - Eventura

Human-in-the-Loop (HITL) in GMP: Maintaining Human Oversight of AI-Assisted Decisions

_______________________________________________________________________________________________________ 📅 October 21, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

Dr. Ginette Collazo

GMP Change Controls: Assessing Validation Impact and Regulatory Risk Before Implementation

_______________________________________________________________________________________________________ 📅 October 22, 2026 | 🕒 11 PM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

DANIELLE DELUCY

Aseptic Process Simulations: Designing and Evaluating Media Fills

_______________________________________________________________________________________________________ 📅 September 30, 2026 | 🕒 11 PM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

DANIELLE DELUCY

Determining Root Cause in Sterility Failure Investigations

_______________________________________________________________________________________________________ 📅 October 15, 2026 | 🕒 11 PM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

DANIELLE DELUCY

Repeat Deviations and OOS: Strengthening RCA-CAPA Effectiveness and Managing Investigation Backlogs | Risk-Based Decisions on When to Investigate Deeper, Escalate, or Close

_______________________________________________________________________________________________________ 📅 October 07, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 2 Hours

Measuring SOP Effectiveness Across Training, Qualification, GMP Operations, and AI-assisted environments

_______________________________________________________________________________________________________ 📅 September 17, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

MICHAEL ESPOSITO

Software Validation Observations in FDA Warning Letters and Consent Decrees: Patterns, Root Causes, and Remediation Expectations

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

MEREDITH CRABTREE

Cleaning Validation Lifecycle Control: Monitoring Drift, Method Sensitivity, and Revalidation Decisions

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

MEREDITH CRABTREE

Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally

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

MEREDITH CRABTREE

Maintaining Traceability Between User Requirements, Risk Controls and Verification Evidence

_______________________________________________________________________________________________________ 📅 September 23, 2026 | 🕒 11 PM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

Configuration Control vs. Document Control – Managing Design Changes Across Modern Quality Systems

_______________________________________________________________________________________________________ 📅 September 23, 2026 | 🕒 11 PM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

2-Day Seminar: Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice

_______________________________________________________________________________________________________ 📅 October 26 - 27, 2026 | 🕒 11 AM - 2 PM Eastern Time US | 🕒 3 - 6 PM GMT | ⏳ 2 Days

CAROLYN TROIANO

Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated

_______________________________________________________________________________________________________ 📅 September 29 - 30, 2026 | 🕒 11 AM - 1 PM Eastern Time US | 🕒 3 - 5 PM GMT | ⏳ 2 Days

Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions

_______________________________________________________________________________________________________ 📅 October 21, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

JOHN E. LINCOLN

Risk-based Excel Spreadsheet Validation - 2026 Updates

_______________________________________________________________________________________________________ 📅 September 25, 2026 | 🕒 12 PM Eastern Time US | 🕒 4 PM GMT | ⏳ 90 Minutes

CAROLYN TROIANO

Packaging and Labeling Controls: Reducing Hidden Errors Before They Escalate

_______________________________________________________________________________________________________ 📅 August 28, 2026 | 🕒 11 PM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

MICHAEL ESPOSITO

Human Error Trends as AI Enters GMP Operations: What QA Leaders Should Expect and Monitor

_______________________________________________________________________________________________________ 📅 August 26, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

Dr. Ginette Collazo

AI and Decision Making in GMP: Resolving Conflicts Between Human Judgment and AI Recommendations

_______________________________________________________________________________________________________ 📅 November 01, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

Dr. Ginette Collazo

Global eCTD v3.2.2 and eCTD v4.0 Operations: Managing FDA and EU Submissions Complexity Across the Product Lifecycle

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

JOHN E. LINCOLN