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      Live - AUG 05

      QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness

      MD1382
      JOSÉ MORA

      _______________________________________________________________________________________________________ πŸ“… August 05, 2026 | πŸ•’ 11 PM Eastern Time US | πŸ•’ 3 PM GMT | ⏳ 90 Minutes

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      Live - AUG 07

      Continued Process Verification (CPV): Using Review-by-Exception Approaches for Process Monitoring and Product Quality

      FDB1614
      MEREDITH CRABTREE

      _______________________________________________________________________________________________________ πŸ“… August 07, 2026 | πŸ•’ 11 AM Eastern Time US | πŸ•’ 3 PM GMT | ⏳ 90 Minutes

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      Live - AUG 10

      Acceptance Criteria for AI Validation: Determining What β€œReliable” Actually Means in GxP Systems

      FDB3243
      CAROLYN TROIANO

      _______________________________________________________________________________________________________ πŸ“… August 10, 2026 | πŸ•’ 12 PM Eastern Time US | πŸ•’ 4 PM GMT | ⏳ 90 Minutes

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      Live - AUG 12

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

      MD3754
      JOHN E. LINCOLN

      _______________________________________________________________________________________________________ πŸ“… August 12, 2026 | πŸ•’ 11 AM Eastern Time US | πŸ•’ 3 PM GMT | ⏳ 90 Minutes

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      Live - AUG 13

      Packaging and Labeling Controls: Reducing Hidden Errors Before They Escalate

      FDB1286
      MICHAEL ESPOSITO

      _______________________________________________________________________________________________________ πŸ“… August 13, 2026 | πŸ•’ 11 PM Eastern Time US | πŸ•’ 3 PM GMT | ⏳ 90 Minutes

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      Live - AUG 20

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

      FDB1285
      MICHAEL ESPOSITO

      _______________________________________________________________________________________________________ πŸ“… August 20, 2026 | πŸ•’ 11 PM Eastern Time US | πŸ•’ 3 PM GMT | ⏳ 90 Minutes

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      Live - AUG 24

      Using EU GMP Annex 22 as the Framework for Governing AI Systems, Validation Traceability, and Data Integrity Controls

      FDB1608
      CHARLES H. PAUL

      _______________________________________________________________________________________________________ πŸ“… August 24, 2026 | πŸ•’ 11 PM Eastern Time US | πŸ•’ 3 PM GMT | ⏳ 60 Minutes

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      Live - AUG 26

      EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations

      MD3753
      JOHN E. LINCOLN

      _______________________________________________________________________________________________________ πŸ“… August 26, 2026 | πŸ•’ 11 AM Eastern Time US | πŸ•’ 3 PM GMT | ⏳ 90 Minutes

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      SEP 08-09

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

      FDB3537
      G. SUNDAR

      _______________________________________________________________________________________________________ πŸ“… September 08 - 09, 2026 | πŸ•’ 11 AM - 1 PM Eastern Time US | πŸ•’ 3 - 5 PM GMT | ⏳ 2 Days

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