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Live - SEP 04

Risk-based Excel Spreadsheet Validation - 2026 Updates

_______________________________________________________________________________________________________ 📅 September 04, 2026 | 🕒 12 PM Eastern Time US | 🕒 4 PM GMT | ⏳ 90 Minutes

CAROLYN TROIANO
FDB3644
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Live - SEP 10

AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend

_______________________________________________________________________________________________________ 📅 September 10, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 90 Minutes

MEREDITH CRABTREE
FDB1417
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Live - SEP 09

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

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

JOHN E. LINCOLN
FDB3755
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Live - SEP 09

OTC Monograph Reform and OMUFA II: What FDA’s Modernized OTC Framework Means for Manufacturers

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

MEREDITH CRABTREE
FDB1418
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Live - SEP 03

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

_______________________________________________________________________________________________________ 📅 September 03, 2026 | 🕒 11 AM Eastern Time US | 🕒 3 PM GMT | ⏳ 60 Minutes

Dr. Ginette Collazo
FDB1308
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SEP 10-11

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

_______________________________________________________________________________________________________ 📅 September 10 - 11, 2026 | 🕒 11 AM - 1 PM Eastern Time US | 🕒 3 - 5 PM GMT | ⏳ 2 Days

G. SUNDAR
FDB3537
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SEP 10-11

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

_______________________________________________________________________________________________________ 📅 September 10 - 11, 2026 | 🕒 11 AM - 2 PM Eastern Time US | 🕒 3 - 6 PM GMT | ⏳ 2 Days

CAROLYN TROIANO
FDB3244
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Live - SEP 17

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
FDB1285
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Live - SEP 11

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
MD3754
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Live - SEP 23

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

JOSÉ MORA
MD1383
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Live - AUG 28

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
FDB1286
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Live - AUG 26

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
FDB1307