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 11, 2018 | Compliance, FDA, FDA Inspection, Improvement, ISO, Job Opportunities, Leadership, Manufacturing, Medical Devices, Personal Development & Improvement, Professional Development, Quality Systems, Recruiting, Regulatory, Team Work
One Team…..One Goal – Your Business Transformation!...
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 15, 2018 | Admiration, Audits, Biotech, Business Decision Making, Business Transformation, Communication, Compliance, Creativity, Imagination, Improvement, Innovation, Leadership, Motivation, Personal Development & Improvement, Pharma, Regulatory, Respect, Rewarding
Dr. Jose Eduardo Vidal, YOU have them all! It was not destiny that got you a new position. It was your ability to make your own destiny. On behalf of the entire team of Subject Matter Experts from Lean Enterprise Consulting, we wish you the very best on your new...
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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