by Thomas Agrait | Sep 24, 2018 | Communication, Compliance, FDA New Guidelines, Guidelines, Improvement, Innovation, Process Improvement, Professional Development, Regulatory, Social Responsibility
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...
by Thomas Agrait | Sep 16, 2018 | Business Decision Making, Business Transformation, Collaboration, Commitment, Communication, Community Service, Connection, Creativity, Ethics, Improvement, Innovation, Interaction, Job Opportunities, Leadership, Logistics, Manufacturing, Medical Devices, Motivation, Networking Event, People Engagement, Personal Development & Improvement, Process Improvement, Professional Development, Profitability, prosperous, Readers Engagement, Recognition, Social Responsibility, Supply Chain, Team Work, Technology
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...
by Thomas Agrait | Sep 15, 2018 | Admiration, Business Transformation, Collaboration, Commitment, Communication, Connection, Creativity, Curiosity, Diversity, Efficiency, Energy, Engineering, Envision, Imagination, Improvement, Innovation, Leadership, Motivation, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, prosperous, Readers Engagement, Recognition, Respect
Eng. Daniel Hernandez-Neris, on behalf of your former team at Lean Enterprise Consulting Inc.WE want to express our congratulations & appreciation for your achievement of this milestone at Bristol-Myers Squibb. You are a great example of the quality of...
by Thomas Agrait | Sep 6, 2018 | Audits, Biotech, Communication, Compliance, FDA New Guidelines, Process Improvement, Quality Systems, Regulatory, Technology
Quality in 510(k) “Quik” Review Program Pilot Today the U.S. Food and Drug Administration (FDA) is launching the Quality in 510(k) (“Quik”) Review Program pilot. The goal of this pilot is to simplify how manufacturers of certain moderate-risk medical...
by Thomas Agrait | Aug 13, 2018 | Audits, Biotech, Business Decision Making, Business Transformation, CAPA, Commitment, Communication, Compliance, Creativity, Curiosity, Diversity, Efficiency, Emotional Intelligence, Energy, Engineering, Envision, Ethics, FDA, FDA Inspection, Guidelines, Improvement, Innovation, Laws, Leadership, Manufacturing, Medical Devices, Mitigation Strategies, Motivation, People Engagement, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Profitability, Regulatory, Respect, Risk Assessment, Team Work, Technology, Training
If you’re reading this post, then you’re probably considering utilizing our team expertise at your company. As President and CEO of Lean Enterprise Consulting Inc. (LEC), I’m very pleased to hear that! When you join forces with the great team of...
by Thomas Agrait | Aug 10, 2018 | Business Transformation, CAPA, Communication, Compliance, Creativity, Curiosity, Diversity, Efficiency, Engineering, FDA Inspection, Guidelines, Improvement, Innovation, ISO, Job Opportunities, Manufacturing, Medical Devices, Motivation, Opening, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Quality Systems, Recruiting, Regulatory
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