QLeaR Advisors
@qlearadvisors
Minneapolis, MNhttps://Qlearadvisors.com Medical Equipment ManufacturingOverview
About QLeaR Advisors
Medical Device, Pharmaceutical, Biologics, and IVD Regulatory and Quality Compliance consulting (GCP, GLP, GMP)
We have an expertise in CAPA/Investigations, Remediation, Supplier Management, Training and Auditing. Due Diligence, inspection preparation, FDA mock audits, 13485/820 QMSR transitions. Risk-based thinking and QMS implementations.
Our Philosophy: Progressive Improvement BEATS Postponed Perfection. Our methodology for being a change agent is based on this belief.
The Key: Enrolling and engaging people in the change process and getting them to believe that there is a way to attain a high level of operational excellence...step by step, using good project management skills and leadership tools.
We have an expertise in CAPA/Investigations, Remediation, Supplier Management, Training and Auditing. Due Diligence, inspection preparation, FDA mock audits, 13485/820 QMSR transitions. Risk-based thinking and QMS implementations.
Our Philosophy: Progressive Improvement BEATS Postponed Perfection. Our methodology for being a change agent is based on this belief.
The Key: Enrolling and engaging people in the change process and getting them to believe that there is a way to attain a high level of operational excellence...step by step, using good project management skills and leadership tools.