Senior Management Executive

Senior Management Executive

Allow me to introduce Eng. Eddie Ignacio, S.S.M.B.B.-  one of the top SME at Lean Enterprise Consulting who brings to our company a vast and profound C- Suite Multinational Experience His Industry Background Includes Medical Devices/Pharmaceutical, Electronic,...
Elite “coterie” of Professionals !

Elite “coterie” of Professionals !

Do you classify yourself as an elite breed of professional that looks for and hire for competencies, knowledge, people skills, and ROI on your consultant’s services above all other considerations? If you answered yes, then you are the rare and unique category of...
Lawsuits,Federal Budget Cuts and FDA – The Prophecy !

Lawsuits,Federal Budget Cuts and FDA – The Prophecy !

In a previous post, I shared with all of you my opinion about Mr. Trump’s “nefarious” decision to reduce the FDA budget and the rise of a “Regulatory Anarchy”. Today, in the newspaper, to validate my prophecy, I found this...

Over-spending $ Responding to a FDA 483 ? No need

Is your company over-spending in regulatory support? Dealing with a 483? FDA Warning Letters requires immediate and expert attention …they mean that the Agency has found that one or more of your practices, processes, or products are in violation of FDA...
LEC PRAESENTI

LEC PRAESENTI

The U.S. Food and Drug Administration (FDA) issued two guidances today related to shared system risk evaluation and mitigation strategies (REMS). A REMS is a required risk management plan that uses tools beyond the approved labeling (prescribing information) to manage...

Fundamentals of Pharmaceutical Filtration Technology @ Miami,Fl

ASQ section 1510/1515 Joint Dinner Meeting: May 15, 2018 And Lean Enterprise Consulting Inc. Invites you to join us REGISTER HERE Speaker Eng. Julio Juarbe,S.M.E. Presentation Topic  Filtration – Protecting What Matters most Every Day! at Shula’s Hotel,  15255 Bull...