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USP Inspections in 2026: What Surveyors Are Actually Citing

  • 74 minutes
  • 39 slides
What we'll cover
  • 0:00 2026 Citation Landscape
  • 9:00 Sterile Compounding Findings
  • 22:00 Nonsterile Compounding Hotspots
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What you'll take away

Practical shifts you can apply this week

  • Identify 2026 Citation Themes

    Spot the survey language, records, and observed practices most likely to trigger findings.

  • Compare High-Risk Findings

    See where sterile, nonsterile, and hazardous workflows break down in different ways.

  • Diagnose Documentation And Practice Gaps

    Catch the small mismatches that quietly grow into reportable deficiencies.

  • Evaluate Monitoring Training Competency Evidence

    Pressure-test whether your proof would hold up when a surveyor starts asking follow-ups.

  • Draft A Focused 90-Day Action Plan

    Leave with priorities, owners, and next steps you can put on a calendar.

Agenda

What we'll cover

  1. 0:00

    2026 Citation Landscape

    What surveyors can verify quickly, and why observable practice beats a tidy binder.

  2. 9:00

    Sterile Compounding Findings

    Air and surface monitoring, garbing drift, workflow issues, BUD support, and deviation handling.

  3. 22:00

    Nonsterile Compounding Hotspots

    Where records, cleaning evidence, traceability, and training gaps start looking citable.

  4. 32:00

    Hazardous Drug Control Gaps

    Containment, PPE, spill response, and exposure records that tell slightly different stories.

  5. 42:00

    Documentation That Fails

    Missing trails, weak CAPA closure, and records that cannot prove who did what and when.

  6. 49:00

    Competency Oversight Weak Points

    When completion looks fine on paper but demonstrated performance says otherwise.

  7. 55:00

    90-Day Readiness Plan

    Rank risks, assign owners, and design one mock survey worth doing.

  8. 59:00

    Recap And Q&A

    Leave with three named fixes, one accountable owner, and a date on the calendar.

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