by Thomas Agrait | Jan 27, 2020 | Centers for Disease Control and Prevention (CDC), Citizenship, Community Service, Coronavirus, Cultural Diversity, Curiosity, Cybersecurity, Disaster Response, Eco-Anxiety, Education, Emergency Plan, Engagement, Environmental Responsibility, Ethics, FDA, Fear Management, Guidelines, Human Rights, Innovation, Leadership, Lean Enterprise Consulting, LEC Universitas, Love & Compasion, Mindfulness, Mother Nature, Pathogens Contamination, People Engagement, Public Health, Public Safety, Puerto Rico, Readers Engagement, Survivals, Training, U.S. Chamber of Commerce Foundation, Universal Citizens, Universe Reciprocity, Values, virus, World Health Organization
Dear Friends, Thank all of you for registering for our webinar. Due to high demand, we have opened a second webinar line so more attendees can experience the same content. Please go to this link to complete your registration and receive the phone line and log-in...
by Thomas Agrait | Dec 26, 2019 | 483, Abundant Life, Admiration, Attitude, Believes, Business Decision Making, Business Process Transformation, CAPA, cGMP, Cleaning Validation, Collaboration, Compliance, Computer System Validation, Connection, Cost Reduction, Creativity, Cultural Diversity, Curiosity, Cybersecurity, D-M-A-I-C-S, Diversity, Draft Guidance, Drug Evaluation, Drugs & Biologics, Education, Efficiency, EMEA, Energy, Engineering, Envision, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News, FDA/CDER, FIIILE, Foreign Manufacturers, Gap, Good Documentation Practices, Guidelines, Happy New Year, Improvement, Innovation, ISO 56000, Leadership, Lean Enterprise Consulting, LEC Universitas, Manufacturing, Manufacturing Engineering, Medical Devices, Mindfulness, NDA, Neuro-Linguistic Programming, NeuroGneering @ VORTEX, Personal Development & Improvement, Pharma, Process Improvement, Quality Engineering, Quality System Operations, Quality Systems, Regulatory, Supplier Quality Agreement, Supplier Quality Management, Team Work, Technology, Third Party Audits, TIER System, Warning Letter
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by Thomas Agrait | Dec 10, 2019 | Actions, Adaptive Design, ANVISA, Attitude, Audits, Believes, Biotech, Brain, Branding, Business Decision Making, Business Process Transformation, Business Transformation, CAPA, cGMP, Cleaning Validation, Collaboration, Commitment, Communication, Compliance, Computational Neuroscience, Cost Reduction, Creativity, Cultural Diversity, Curiosity, Cybersecurity, D-M-A-I-C-S, Diversity, Drugs & Biologics, Eco-Anxiety, Education, Efficiency, EMA, Emotional Intelligence, Energy, Engagement, Engineering, Envision, Ethics, FDA, Good Documentation Practices, Guidelines, Human Error, Improvement, Inclusion, Innovation, Internal Auditor Training, Internet of Things (IoT), Interpersonal Intelligence, ISO, Leadership, Lean Enterprise Consulting, Lean Six Sigma, LEC Universitas, Manufacturing, Manufacturing Engineering, Medical Devices, Mindfulness, Molding Academy, Motivation, Multiple Intelligences, Neuro-Linguistic Programming, NeuroGneering @ VORTEX, NeuroLeadership, New Culture, People Engagement, Personal Development & Improvement, Pharma, Process Improvement, Profitability, QA, Quality Engineering, Quality System Operations, Quality Systems, Raw Material Inspection / Testing, RDC16, Recognition, Regulatory, Risk Assessment, Safety, SMED, Strategic Planning, Strengths Psychology, Supplier Quality Agreement, Supplier Quality Management, Supply Chain, Team Work, TIER System, Time Management, Training, Validation, Value Stream Mapping
LEC Universität At Lean Enterprise Consulting we realized that 2020 is just around the corner. Right now, many of our friends and customers are asking us for our Academia in order to set a plan to fine-tune the skills-set of their team members in order to get ahead...
by Thomas Agrait | Dec 10, 2019 | Actions, Artificial Intelligence - AI, Audits, Biotech, Business Decision Making, Business Process Transformation, CAPA, cGMP, Clinical Trials, Communication, Compliance, Computational Neuroscience, Cost Reduction, D-M-A-I-C-S, Deep Learning (DL), Draft Guidance, Drugs & Biologics, Efficiency, EMA, Emotional Intelligence, Energy, Engineering, Ethics, FDA, Guidelines, Improvement, Innovation, Medical Devices, Multiple Intelligences, NeuroGneering @ VORTEX, NeuroLeadership, Personal Development & Improvement, Pharma, Process Improvement, QA, Quality System Operations, Quality Systems, Raw Material Inspection / Testing, Regulatory, Risk Assessment, ROI, Safety, SMED, Strategic Planning, Strengths Psychology, Supplier Quality Management, Supply Chain, Team Work, Technology, Time Management, Training, VORTEX by LEC
Education is what remains after one has forgotten what one has learned in school. Albert Einstein I would like to schedule a time to talk to all of you interested in developing your team in areas that will improve your performance and the bottom line of your...
by Thomas Agrait | Nov 18, 2019 | Business Process Transformation, Business Transformation, cGMP, Collaboration, Commitment, Communication, Community Involvement, Compliance, Draft Guidance, Efficiency, Envision, FDA, FDA Inspection, FDA News, Guidelines, Laws, Leadership, Lean Enterprise Consulting, LEC Universitas, Manufacturing, Mother Nature, Outsourcing, Personal Development & Improvement, Pharma, Professional Development, Public Health, Public Safety, Quality Systems, Raw Material Inspection / Testing, Regulatory, Risk Assessment, Safety, Supplements, Supply Chain
On Thursday, December 12, the South Florida Manufacturers Association and it’s Regulatory Affairs and Quality Committee will be hosting its first seminar titled: To Be or Not to Be Regulated? The Food and Drug Administration (FDA) regulates both finished dietary...
by Thomas Agrait | Nov 13, 2019 | Business Decision Making, Business Process Transformation, Draft Guidance, FDA New Guidelines, FDA News, Guidelines, Leadership, Legal, Logistics, Medical Devices, Process Improvement, Regulatory, Supply Chain
Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices to explain why the FDA may deny issuing a Certificate to Foreign Government (CFG)...
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