QLeaR Advisors

medical devices

About

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.

Technologies

Outlook WordPress.org Nginx Mobile Friendly Google Tag Manager

Keywords

audits training technical writing medical device biologics capa fda supplier controls supplier audits eu mdr iso 13485 investigation pharmaceutical gap analysis medical equipment manufacturing attrition reduction in qa/qc teams remediation gmp regulatory compliance project management biologics compliance change management ivd regulatory support capa investigations lab root cause analysis supplier management investigation hands-on training consulting investigation training investigation report writing

Location

Minneapolis, Minnesota, United States

Related Companies

Companies in the same industry