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Connection, Cost Reduction, Creativity, Cultural Diversity, Curiosity, Cybersecurity, D-M-A-I-C-S, Diversity, Draft Guidance, Drug Evaluation, Drugs & Biologics, Education, Efficiency, EMEA, Energy, Engineering, Envision, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News,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 24, 2019 | Admiration, ANDA, Biologics, Biotech, Business Process Transformation, CAPA, CDERSBIA, Celebration, cGMP, Cleaning Validation, Clinical Trials, Cost Reduction, Creativity, D-M-A-I-C-S, eCTD Format, Education, EMA, EMEA, Engagement, Engineering, FDA, Improvement, Innovation, Manufacturing, Manufacturing Engineering, Medical Devices, Pharma, Process Improvement, QA, Quality Engineering, Quality System Operations, Quality Systems, Team Work, Technology, Warning Letter
James, the newest member of our consulting team, James is a successful Sr. Manufacturing Operations/Plant Manager with broad cross-functional experience in the Pharmaceutical/Medical Device Industry. With previous positions as Plant Manager, Sr. Director of Operations...
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 22, 2019 | ANDA, ANVISA, Audits, Business Decision Making, Business Process Transformation, CAPA, CDERSBIA, cGMP, Cultural Diversity, D-M-A-I-C-S, DMF, Draft Guidance, eCTD Format, Efficiency, EMA, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, Gap, Human Error, Improvement, Innovation, ISO, Latin America, Lean Enterprise Consulting, LEC Universitas, Manufacturing, Medical Devices, Mitigation Strategies, NDA, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Profitability, Quality System Operations, Quality Systems, Recalls, Regulatory, Risk Assessment, RobertoCorrea, Strategic Planning, Supplier Quality Management, Training, Warning Letter
Eng. Roberto Correa Lead Consultant, Global Regulatory Affairs and Quality Assurance Lean Enterprise Consulting Eng. Correa is a Florida, USA – based global consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and...
by Thomas Agrait | Nov 21, 2019 | Business Decision Making, Business Process Transformation, Business Transformation, cGMP, Citizenship, Collaboration, Commitment, Communication, Community Involvement, Compliance, Connection, Creativity, Draft Guidamce, Efficiency, Engagement, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News, Improvement, Innovation, Manufacturing, Motivation, Networking Event, Pharma, Process Improvement, Professional Development, ProfessionalAssociation, Public Health, Public Safety, QA, Quality Systems, Recalls, Regulatory, Respect, Risk Assessment, Supplements, Warning Letter
You and your team are invited on Thursday, December 12, the SFMA’s Regulatory Affairs and Quality Committee will be hosting its first seminar titled: To Be or Not to Be? (Register now) Looking forward to seeing you there to share our knowledge and regulatory concerns...
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