LEC – Organizational Capability for QA Assessment

Today we would like to introduce you to a process that one of our Quality System SME, Eng. Roberto Correa with his LEC team, designed and validated to perform a Quality Capability within any Life Sciences company in a very short time frame. Utilizing the D-M-A-I-C...

Knowing Your Counterparts!

 One of the biggest challenges I face in a daily fashion;as a Process Improvement expert, is to deal with the “Organizational Silos (OS)”. These invisible organizational components, non-documented and sometimes disregarded by the management team; present a...

Is your company running short in resources?

Is your company running short of resources for those critical manufacturing, quality & regulatory projects? At Lean Enterprise Consulting we have an excellent hands-on team of engineers, validation specialist, CAPA Specialist, Process Improvement SMEs, regulatory...

Fear to Organizational Improvement!

Fear can prevent your organization to achieve higher levels of performance and efficiency. I have heard so many times, Managers from all over the world, from a wide spectrum of industries, asked me about what can be done to eliminate the “fear” within...

Benefit-Risk Factors – Different Technological Charasteristics

The FDA Issues Final Guidance – Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics Today, the U.S. Food and Drug Administration (FDA) released the final...

Empresario Puertorriqueño, urgente!

Estimado Empresario Puertorriqueño : Actualmente nuestra firma , Lean Enterprise Consulting junto a  la Asociacion de Profesionales de Florida  (PROFESA) y la Asociacion de Manufactureros del Sur de Florida (SFMA) nos hemos dado a la inmensa tarea de levantar un censo...