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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by Thomas Agrait | Aug 8, 2018 | Audits, Biotech, Business Decision Making, Business Transformation, CAPA, Cargo Security, Commitment, Communication, Compliance, Creativity, Curiosity, Diversity, Efficiency, Energy, Engineering, Ethics, FDA, FDA Inspection, Guidelines, Human Error, Improvement, Innovation, Leadership, Logistics, Manufacturing, Medical Devices, Mitigation Strategies, Motivation, People Engagement, Pharma, Process Improvement, Professional Development, Profitability, Quality Systems, Recruiting, Regulatory, Risk Assessment, ROI, Supply Chain, Team Work, Technology, Training, Transportation, Uncategorized
Dear Lean Enterprise Consulting Customers & Prospects: Thanks for accepting our invitation to know more about our Firm! These are our core services: Lean Six Sigma Enterprise Training and Consulting Validation & Commissioning Quality Engineering...
by Thomas Agrait | Jul 1, 2018 | Audits, CAPA, Compliance, Ethics, FDA, FDA Inspection, Guidelines, Human Error, Improvement, Laws, Leadership, Manufacturing, Mitigation Strategies, Pharma, Process Improvement, Quality Systems
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...
by Thomas Agrait | Jun 26, 2018 | Audits, Biotech, Business Transformation, CAPA, Commitment, Compliance, Envision, Ethics, FDA, FDA Inspection, Guidelines, Human Error, Improvement, Innovation, Laws, Leadership, Manufacturing, Medical Devices, Mitigation Strategies, Motivation, People Engagement, Pharma, Process Improvement, Profitability, Quality Systems, Regulatory, Risk Assessment, Team Work, Technology
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...
by Thomas Agrait | Jun 6, 2018 | Audits, CAPA, Communication, Compliance, Engineering, FDA Inspection, Guidelines, Human Error, Innovation, ISO, Logistics, Manufacturing, Medical Devices, Mitigation Strategies, Quality Systems, Recruiting, Regulatory, Risk Assessment, Training
Meet Yvette @ Lean Enterprise Consulting Inc. Professional Summary: Dedicated professional, eager to provide services in general Quality Systems, using knowledge acquired during 25 years of service to regulated environments: Pharmaceuticals, Medical Devices,...
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