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Quality Excellence, LLC

Knowledge, Learning & Human Systems

Capture the knowledge that walks out during a transition, and design roles and procedures so human error has nowhere to happen.

Knowledge and learning

  • Identify and preserve technical and business knowledge in permanent repositories.
  • Identify at-risk knowledge from restructuring, joint ventures, M&A, divestitures, contract manufacturing or technology transfer.
  • Incorporate critical knowledge into training plans.
  • Learning gap assessments, action plans and curricula optimization.
  • Development of learning programs across business, organizational development, regulatory and quality systems.

Human systems

  • Roles and responsibilities aligned to business strategy, and employee manuals that match them.
  • Procedure assessment to reduce human error, and human error analysis with preventive actions.
  • Competency assessments, gap identification and capability improvement plans.
  • Training curricula design, optimization and metrics.
A GMP training classroom with gowned participants facing a diagram on screen

Danister Quiñones, PhD

Global Organizational and Culture Expert · 35 years in biopharma

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Is your site ready for the next inspection?

Tell us what you are facing — an upcoming inspection, a gap assessment, a remediation plan — and you will get a concrete route back.

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