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.


Danister Quiñones, PhD
Global Organizational and Culture Expert · 35 years in biopharma
See the credentialsOther practices
Product Registration
Registration agent for biopharmaceutical products and non-prescription drugs in the Commonwealth of Puerto Rico.
Organizational Culture Transformation
Measure how the organization actually behaves, then align it with the business strategy it is supposed to serve.
Quality Systems
Assess your systems against global regulations, then design procedures, metrics and training that hold up under inspection.
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.

